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Newtown May 18, 2020 (Thomson StreetEvents) -- Edited Transcript of Onconova Therapeutics Inc earnings conference call or presentation Thursday, May 14, 2020 at 8:30:00pm GMT

* Abraham N. Oler

Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel

Onconova Therapeutics, Inc. - CFO

Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development

* Steven M. Fruchtman

Onconova Therapeutics, Inc. - CEO, President & Director

Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Ladies and gentlemen, thank you for standby, and welcome to the Onconova Therapeutics First Quarter 2020 Earnings and Corporate Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Mr. Avi Oler, Senior Vice President, Corporate Development and General Counsel. Thank you, sir. Please go ahead.

Abraham N. Oler, Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel [2]

Thank you, operator. Good afternoon and welcome to Onconova's First Quarter 2020 Corporate Update and Financial Results Conference Call. Earlier this afternoon, we issued a press release outlining our financial results and business progress during the quarter. If you have not seen this press release, it is available on the Investor Relations page of our website at http://www.onconova.com.

On today's call, Dr. Steve Fruchtman, President and CEO, will discuss the company's recent highlights and anticipated clinical and business milestones. After Steve completes his opening remarks, Mark Guerin, our Chief Financial Officer, will review first quarter financial results. Following Mark's report, we will move to the Q&A portion of the call, which will be joined by Dr. Rick Woodman, our Chief Medical Officer. Lastly, Steve will come back with some final comments and a review of our upcoming milestones.

Before we begin, I remind everyone that statements made today during this conference call will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made as the underlying facts and circumstances may change. Except as required by law, Onconova disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. Please see the forward-looking statements disclaimer in the press release issued this afternoon and the risk factors in the company's current and future filings with the SEC.

With that, it is my pleasure to now turn the call over to Steve.

Thank you, Avi. Good afternoon, everyone, and thank you for joining today's call. First, our hearts go out to the many individuals and families impacted by the devastating COVID-19 pandemic. The world has truly changed, and we hope that brilliant scientists from around the world can bring new therapies and preventions to this devastating plague.

Onconova demonstrated significant progress during the first quarter of 2020, highlighted by the completion of enrollment of our pivotal Phase III INSPIRE trial in higher-risk myelodysplastic syndromes. We are fortunate to have achieved full enrollment prior to the profound impact of the worldwide COVID-19 pandemic, which has forced disruptions to research studies at many hospitals and cancer centers across our globe.

With enrollment now completed, Onconova's pivotal Phase III INSPIRE trial is advancing to the next pivotal catalyst. Based on historical survival trends in the INSPIRE trial, we continue to anticipate reporting top line survival data in the second half of 2020. And we expect to present the results of the INSPIRE trial at a major medical meeting later this year. With INSPIRE enrollment now complete, we are preparing for when we reach 288 survival events before analyzing and releasing top line survival data.

To shorten time lines for our anticipated NDA submission to the FDA, we have already begun NDA work prior to data readout. We are working with regulatory consultancy experts on our NDA document for the U.S. FDA as well as on the MAA document for the EMA to be in position to expedite our health authority applications when data becomes available.

We are also advancing our plans to be ready for commercialization. And to develop internal Onconova expertise, we have nominated a commercial expert, Ms. Terri Shoemaker, to our Board, who was instrumental in the commercialization of azacitidine, the most frequently prescribed pharmaceutical agent in higher-risk MDS.

As you recall, INSPIRE is an open-label, randomized, controlled, international study designed to determine the efficacy, safety and tolerability of single-agent intravenous rigosertib in the treatment of patients with second-line, high-risk MDS. Patients in this study are less than 82 years of age and have progressed on, relapsed or failed to respond to previous treatment with the standard of care hypomethylating agent therapy. The study randomized patients to receive either intravenous rigosertib with best support of care or the physician's choice of therapy with best support of care.

The primary end point of this study is overall survival of all randomized patients in the intent-to-treat population. There is also a second opportunity for an FDA approval, which is the sequential analysis of the overall survival of the very high-risk subgroup as defined by the revised International Prognostic Scoring System. Should rigosertib prolong survival in the INSPIRE trial in a statistically significant manner, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years.

Today, we disclosed that at the European Hematologic Association's upcoming virtual congress, Onconova and our collaborators at MD Anderson Cancer Center and the centers participating on the INSPIRE trial have an accepted presentation. The presentation, which was just posted to the European Hematology Association's website, detail the impact of the RAS pathway mutations on patients failing azacitidine and is entitled, Mutations in RAS Pathway Genes Correlates with Type of Failure to Azacitidine: Genomic Analysis at Randomization onto the INSPIRE Trial.

As you know, advances in the understanding of genomics have revolutionized cancer care. Participants on the INSPIRE trial received deep genomic sequencing of their blood or bone marrow at randomization and at multiple time points in their treatment during the study. The genomic data from the INSPIRE trial identifies the most common mutations in high-risk MDS following azacitidine failure, including those of the RAS pathway that may be targeted by rigosertib. We believe this data presentation will further advance the learnings about MDS, the important role of genomics and the possible place of rigosertib treatment for MDS and other RAS-driven cancers.

We have made important progress with our additional pipeline programs as well. In addition to the INSPIRE trial, we are advancing plans for a pivotal Phase II/III combination trial of oral rigosertib and azacitidine in adult patients with HMA-naive, higher-risk MDS. We received feedback from the FDA in 2019 and are preparing a Phase II/III protocol for submission based on their guidance. We anticipate meeting with the FDA in the third quarter of this year after submitting a Type C meeting request to consult with FDA. We anticipate this new registration trial will begin later this year following the FDA feedback and following the survival pivotal data readout from our INSPIRE study.

We have also received notification that the Phase I trial, which forms the basis for this new pivotal trial with oral rigosertib combined with azacitidine in HMA-naive, high-risk MDS patients, has been accepted for publication in Leukemia Research and anticipate its publication in the upcoming months.

In addition to studying rigosertib in MDS, we are primed for additional rigosertib development progress, including the to be initiated Phase I/IIa study of rigosertib plus nivolumab in Stage 4 KRAS-mutated lung adenocarcinomas following the reopening of clinical cancer research programs post the COVID-mandated stoppage as well as additional planned indications for rigosertib in other KRAS-mutated cancers and our pipeline programs. The study in KRAS-mutated lung adenocarcinoma will be an investigator-sponsored trial, and we anticipate the first patient will be enrolled following the mitigation of the burden of the COVID pandemic that has been placed on our academic medical centers.

While checkpoint inhibitors represent a significant advancement in the standard of care in treating lung cancer and have achieved blockbuster status many times over, tremendous unmet medical need continues to exist following disease progression. In our view, this makes our novel combination approach with rigosertib a very attractive option to pursue in lung cancer and potentially beyond.

And beyond rigosertib, ON123300 is our investigational first-in-class dual inhibitor of CDK4/6 and ARK5. We believe ON123300 has the potential to treat numerous cancers, including refractory metastatic breast cancer, with CDK4/6 inhibitors already commercially available. For those who are not familiar with this field, CDK inhibitors have emerged as promising compounds targeting very large cancer indications such as hormone receptor-positive metastatic breast cancer. Due to its unique targeting of ARK5 as well as CDK4 and 6, we believe ON123300 has the potential to overcome many of the existing agents' limitations, making it potentially suitable for certain cancers that may not be responsive to the current generation of commercially available CDK4/6 inhibitors. If successful, we believe ON123300 could address this very large market opportunity.

We maintain global rights of ON123300 outside of China. Our partner in China for this compound is HanX Biopharmaceuticals, who funded the Chinese IND-enabling studies. The Chinese IND was approved in January of 2020 by the Chinese health authority. We anticipate a Phase I study may begin in China in the second half of 2020. We also intend for the Chinese IND-enabling studies to comply with our FDA standards. To the U.S. and the rest of the world outside of China, our manufacturer for ON123300 is now qualified. We plan to file a U.S. IND in the fourth quarter of 2020 after obtaining the required manufacturing data.

With regard to business development. During the first quarter, we reacquired rigosertib rights in Greater China. As a result, Onconova controls the rights for rigosertib in the U.S., Europe and China, which are among the largest pharmaceutical markets in the world. Last year, we announced plans to launch an early access program with Inceptua Medicines Group. We anticipate launching this program in select countries in the second half of this year. We expect to continue to evaluate opportunities as we progress from one milestone to the next milestone.

As a reminder, our upcoming Annual General Meeting of Stockholders is coming up on May 27. I encourage stockholders to vote at our upcoming Annual General Meeting. Our proxy materials are available on our website. I am very excited that Onconova's Board of Directors has nominated life science industry veteran, Terri Shoemaker, to join the Board at this time. As mentioned, Terri has highly relevant experience in the MDS space. Terri was a key executive in the launch of azacitidine in MDS and will be a very valuable addition to our Board of Directors. We believe her experience in developing and managing commercial organizations in the life science industry will be instrumental in our efforts moving forward as we prepare for potential commercialization of rigosertib.

And now I'd like to turn the call over to Mark Guerin, our Chief Financial Officer, for a discussion of our financial results for first quarter 2020. Mark?

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Mark Patrick Guerin, Onconova Therapeutics, Inc. - CFO [4]

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Thanks, Steve, and good afternoon, everyone. Cash and cash equivalents as of March 31, 2020, totaled $31 million compared to $22.7 million as of December 31, 2019. As previously noted, common stock warrant exercises since our financing transaction in November 2019 have added $10.6 million of cash to our balance sheet. Also, of the almost 29 million stock warrants outstanding as of March 31, 2020, over 80% of them were in-the-money as of May 13. Based on our current projections, we expect that our cash and cash equivalents will be sufficient to fund our ongoing trials and operations into the third quarter of 2021.

Our net loss was $5.1 million for the quarter ended March 31, 2020, compared to $7.6 million for the comparable period in 2019. Research and development expenses were $3.4 million for the quarter ended March 31, 2020, and $4.1 million for the comparable period in 2019. General and administrative expenses were $1.8 million for the quarter ended March 31, 2020, and $3.2 million for the comparable period in 2019.

This completes my financial review. I'll now turn the call back to Steve.

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [5]

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Thank you so much, Mark. With that, we'd like to open the call for questions. After the Q&A, I'll finish with some final closing remarks. Operator, please open the call to Q&A session, and thank you.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Joe Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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Glad you're all doing well. So I have 3 questions, 2 of which, I think, are pretty much logistical. The first one is with regard to INSPIRE, it's great that you enrolled everyone right now and things are progressing and the time lines are still on track. So I was just curious, as part of your -- I guess, call it, your statistical assumptions now with COVID, is there a potential for any loss to follow up for any of these patients that you might not hear about some of these events? Or is it not a concern?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [3]

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I'll ask Rick to take that question, and thank you, Joe.

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [4]

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Yes, Joe. Thank you. The main challenge with the COVID pandemic for our global study has been monitoring of the sites. Fortunately, the number of patients in which we are not able to confirm survival events is extremely small. And we anticipate that continuing in part due to the efforts of our CRO and the clinical research assistance in the field and the team in Onconova as well as some good luck. And I think that we anticipate for the remainder of the collection of survival events that we will be able to continue doing that monitoring. But it is a challenge, and the monitors and the team have -- had to develop unique ways in which to interact with the sites because of the pandemic.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [5]

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Got it, Rick. And then my second logistical question, if you will. I know we discussed this in the past, but sometime has elapsed, and I just want to make sure if your thinking is still the same with regard to the communication strategy around putting out the data for INSPIRE. So since you're looking to present them at a major medical meeting in the second half, I'll just say presumably ASH, would you look to then have one of those typical top line press releases to say, okay, it hit, and we'll give the further data at an upcoming conference? Or not hit as...

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [6]

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Avi, why don't -- I'll ask Avi to take that one, if I may. Go ahead, Avi.

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Abraham N. Oler, Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel [7]

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Sure. Sure thing. In terms of communication, Joe, thanks for the question, but you're exactly right that we would anticipate announcing the data when it is ready at a top line level and presenting full data at an upcoming major medical meeting such as ASH or another major medical meeting.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [8]

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Got it. And then my question is -- or my third and last question. With regard to the upcoming Type C meeting, obviously, you've already had a lot of productive discussions with the FDA around the study design. So I guess I would ask it 2 ways. What's your wish list of what you want to get out of there? And what are the key outstanding things that you need to get solidified?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [9]

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Rick?

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [10]

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Yes, Joe. So I think the first part to your question is that we want to get agreement from the FDA on a novel, unique, adaptive design, a combination of a Phase II/III. And this adaptive design we presented at ASH and some of the unique features. We feel this design is particularly advantageous for us in a variety of ways as well as the medical community and the health authorities. And I think it is the additional challenge that we have is developing, particularly, as we indicated in the abstract at ASH, a very rigorous and robust interim analysis that allows us to move forward into the Phase III part of the study.

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Operator [11]

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Your next question comes from the line of Naureen Quibria with Maxim Group.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [12]

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So first, I guess, starting first with INSPIRE. Can you remind us or are you able to disclose what the current event rate is right now? And is there an average number of events that you're seeing per month? Are you able to discuss that in any detail?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [13]

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I think I'll try my hand at that, and thank you very much. We did reveal, I believe mid-March, that we have over 85% of our survival events that we require of the 288. And the reality is it's quite variable. We do monitor by month every -- the survival events that we see, it is variable. But based on what we are observing, we anticipate reaching pivotal data the second half of 2020. So before the end of the year. It's harder -- it's very hard to make a more accurate prediction than that.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [14]

Original post:
Edited Transcript of ONTX earnings conference call or presentation 14-May-20 8:30pm GMT - Yahoo Finance

People who grew up at high elevations might be less susceptible to the novel coronavirus, according to arecent study of the virus impactin high altitude communities.

The study, which was published by the Respiratory Physiology and Neurobiology journal, compared case data for the virus among communities in Bolivia, Tibet and Ecuador and found that cities and towns in higher elevations have reported fewer COVID-19 cases.

According to BoliviasMinistry of Health websiteLa Paz, Bolivia, has reported 328 cases of the virus and Santa Cruz, Bolivia has reported 2,300 cases as of Friday. La Paz sits 11,943 feet above sea level with a population of 2.7 million people. Santa Cruz is 1,365 feet above sea level with a population of 1.6 million people. For some context, Breckenridge is 9,600 feet above sea level.

This is data that strongly suggests that high altitude is protective, said Dr. Gustavo Zubieta-Calleja, director of the High Altitude Pulmonary and Pathology Institute in La Paz and one of the researchers on the study.

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When the virus attacks a persons lungs it causes hypoxia, a term used for oxygen deficiency in the body. Zubieta-Calleja said its similar to taking a person from sea level and putting them at the peak of Mount Everest. People who live at high altitude develop a tolerance to hypoxia and this may help them fight the virus, he said.

To take the theory even further, Zubieta-Calleja suggests a potential treatment for the virus could be to increase a persons red blood cell count at the early stages of the disease to simulate the biology of people who already live at high altitude.

You have to increase the red blood cells for people in order to survive the acute phase, the critical, phase of COVID, he said.

Zubieta-Calleja said a doctor would have to inject the hormone erythropoietin into a persons blood, which would stimulate the production of red blood cells.

That way your red blood cells increase and when things get more severe, then you have a reserve of red blood cells, he said.

However, some doctors are skeptical of studies like this one, because there is still so much researchers dont know about the virus.

Dr. Erik Swenson, a pulmonologist from the University of Washington, said the study shouldnt change how people live their lives in the pandemic.

It could be true, but they dont have the information to really tease out whether this is hypoxia that is living at these altitudes or is it a whole host of other factors that are relevant to those populations, he said.

Swenson suggested the ability to widely test COVID patients in these areas varies and other factors such as low pollution, healthier lifestyles and the dispersion of molecules at high altitude might contribute to the low number of cases in high altitude areas.

One of Zubieta-Callejas previous articles suggests that ultraviolet light can act as a natural disinfectant, which might be a possible reason for why less people have the virus in high altitude areas as well.

Researchers also arent sure how long a person would have to live at high altitude in order to develop the tolerance to hypoxia required to prevent COVID.

Summit County physician Dr. Christine Ebert-Santos said people living at high altitude shouldnt use this information as a reason to stop following protocols that prevent the spread of the disease.

Because of all the other factors involved in this infection, we really cant change anything that were doing, she said. We still have to be just as cautious about the contagious virus (and) the presence of a person who could spread the virus.

Ebert-Santos also said that people come from all over in Summit County and tolerance to hypoxia varies from person to person.

Even though we could say these are potential mitigating factors of COVID infection, we cannot promise any individual that they have more protection or they would have a less severe course, she said.

Follow this link:
People who grew up at high elevation may be less susceptible to COVID-19, according to study - Vail Daily News

Chowhound

If you're experiencing nervousness, racing thoughts, difficulty getting to sleep or even panic during thecoronavirus pandemic, you're not alone. This is astressful time. It's only natural that we'd feel a little amped and uneasy.

If you're having trouble relaxing, avoidingsugarandcaffeineis a must. These ingredients can further stress our bodies and set us up for anxiety. On the flip side, there are foods that can help support our nervous system, increase our resiliency to stress, and even make us feel calm right after we eat them.

As we move through this crazy time, let's lean on these nine foods that promote relaxation.

A fermented drink that falls somewhere betweenyogurtand milk,kefiris a great addition to your social distancing routine. It can be made from dairy milk ornut milkand contains high amounts of beneficial bacteria, which support a healthy gut microbiome. At first glance, our gut health might seem unrelated to our nervous systems, but it's actually quite the opposite. Studies have shown not only thatstress can alter the microbiomein undesirable ways, but thatanxiety could actually be alleviatedby regulating gut bacteria.

You can drink kefir plain or use it as a creamy base for recipes like in thischilled avocado, cucumber and kefirsoup recipe by Julie Smolyansky.

Fatty fish such assalmonare full of omega-3 fatty acids, which have proven to be extremely beneficial for calming the nervous system. In fact, a systematic review of 19 clinical trials -- published inJAMA Open Network--showed that improvements in anxiety symptoms were associated with omega-3 fatty acid treatment. Try thismaple mustard grilled salmon recipefrom Christine Gallary and add salmon to the menu a few times a week.

Read more:The best places to buy fresh seafood online

Tart cherriescontain high levels of various phytochemicals, including melatonin. You've probably heard of melatonin before; it's known as the "sleep hormone" because our bodies release it in the evening to help us get to sleep. Well,studies have shownthat consuming tart cherry juice increases melatonin levels and can improve sleep quality and duration. If you're having trouble winding down at night, tart cherries might be the perfect food to lean on.

Read more:Other foods that can help you sleep

Have you ever wondered whycucumber wateris so popular? It could be because the smell ofcucumbershas natural stress-relieving properties. And it's not only the smell, either. This low-sugar fruit also contains B vitamins, which help support our central nervous system. In fact,studieshave shown that a B complex vitamin can improve anxiety symptoms compared to placebo.

Plenty of studies have found interesting links between vitamin C and mood. In fact, one study on 42 high school students showed thatvitamin C actually lowered anxiety levels. Citrus fruits -- which includelemons,limes, oranges and grapefruit -- are one of the best ways to get vitamin C in your diet. Here'show to segment citrusfor easy, mess-free eating.

You might not think of Vegemite as a health food, buta study, published in 2018, showed that people who consume yeast-based spreads -- such asMarmite, Vegemite, Promite and Aussiemite -- have lower levels of anxiety and stress. According to the researchers, the B vitamin content in these spreads is likely to thank for their anxiety-reducing powers. To start using Vegemite, try spreading it thinly on one side of agrilled cheese sandwich. It adds a bitter, salty flavor that you may just learn to love.

Onionsare one of the best sources ofprebiotic fiber, which helps to feed healthy gut bacteria. As we now know, a balanced microbiome is essential for optimal mental health. Other sources of prebiotic fiber include leeks,bananas,garlicandapples. Try adding raw onions to salads or whips of thisEasy Caramelized Onions recipefrom Aida Mollenkamp.

Pumpkin seedsare one of the best sources of magnesium, which is often referred to as the "relaxation" mineral and is one of the topstress-relieving nutrients. Many of us are deficient in magnesium, as processed foods are virtually devoid of it. But luckily, pumpkin seeds provide more than 150 mg of magnesium per cup, which is almost 50% of your daily recommended intake. Try thishomemade pumpkin seed milk recipe, from the book Magnesium Everyday Secrets.

Lucky you: Research published in theJournal of Proteome Researchfound that eating about 1 and a half ounces ofdark chocolateper day can actually lead to lower levels of cortisol, which is one of our primary stress hormones. For extra relaxation benefits, dark chocolate also contains significant levels of magnesium. Just make sure you opt for dark chocolate and if you're not sure what to buy, these are thebest dark chocolate barsout there.

Focusing on these foods can help promote relaxation, peaceful sleep, and a sense of calm despite what's going on outside. Luckily, most of these foods are also affordable, delicious and can be prepared in any number of creative ways.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Link:
9 foods that promote relaxation to help you keep calm - CNET

Sean Doolittle has a lot to say about MLBs plans to return to action, but how do his concerns align with the leagues?Illustration: Eric Barrow (Getty)

While there are certainly many miles of financial sparring between MLB owners and players to get through before the league can return to play, issues rooted in the players concerns over safety. While a good portion, if not all, being the players anger over the owners reneging on a deal they made in March to pay prorated salaries is simply the owners acting like jagoffs, the players have contended that the owners financial risk is matched or exceeded by the players physical one. Today The Athletics Ken Rosenthal and Evan Dreilich got hold of the 67-page memo that outlines how MLB will handle the physical risk and testing to get the season under way.

It covers most everything you would think, while not going into detail about some other things you would hope for. At least not yet. Sean Doolittle outlined what his concerns were a week ago, and it seems a pretty fair checklist for what MLB is proposing to get players back into uniform. To wit:

What Rosenthal and Dreilich have outlined does not address what MLB will do about long-term effects or ailments due to anyone contracting COVID-19. That of course is something that MLB can address when it comes up, as someone is likely going to test positive. But it would also do the players faith some good to have some sort of plan now for long-term care and effects. Theres enough mistrust as is. And no, certainly infertility and hormone ratios arent addressed either, and you can bet a fair amount of players want to ask but are afraid to. Its a major question, as even a mild case could cause a players career to be in severe jeopardy if those long term lung-scarring conditions occur.

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This is addressed. At least the spring training portion protocol calls for multiple locker rooms, and as many facilities outside as possible. With stadiums remaining empty there are certainly more options than before to be repurposed for this. You could easily envision even stadium concourses that will have no need to house fans used for this. In addition theres a pretty stiff regiment of cleaning and disinfecting for each clubhouse. Spring training, at least to start, will be staggered as to how many players there are at once.

A curious aspect is that for spring training, if teams are going to use their home stadiums and not Florida or Arizona bases, they are encouraged to find minor league or college stadiums to spread out players. But that also means another facility that has to be regularly cleaned and sanitized, as well as testing for additional staff who have to man that venue. This one feels like its probably not going into the final agreement.

This is the meat of what Rosenthal and Dreilich have reported. Players will be tested multiple times per week, and will have an intake screening for spring training wherever that takes place. Players will be tested upon arriving at spring training, and then isolate while awaiting results. The idea here is to start spring training with a clean slate as it were, and to separate anyone who tests positive from jump street. Of course, false positives and negatives will make that nearly an impossibility, but thats the nature of the beast here.

Players will have temperature and symptom checks twice daily at the facilities, as well as be expected to conduct daily temperature tests at home. Any abnormality there will result in rapid-result testing for that individual.

Another concern of many players is the well-being of their families, and thats addressed in that the testing sites for players at their ballparks will be available to players families and area health care workers and first responders. Nothing is mentioned about what happens if a family member of a player tests positive, but one would have to think that a player would have to be quarantined, along with anyone he came into contact with. Of course, that could be a good chunk of or even the entire team.

As far as the amount of testing, spreading it out to the ballpark sites at least pushes it into the neighborhood of doable. A rough estimate of players, coaches, clubhouse staff, stadium staff is about 100 per team. A couple of tests per week for everyone still would be about 800-1,000 per month, which shouldnt deprive cities of tests to people who really need them.

There doesnt seem to be much mention of these folks, which seems to leave it up to the airlines or hotels or bus companies they work for to make sure they get tested. MLB will have to address what kind of assurances are going in both directions for this to work.

MLBs outline here is pretty strict, in that anyone even with a raised temperature wont be allowed on site and will remotely receive treatment from the team physician. The team physician will also direct anyone else who needs to be tested and isolated, as well. Perhaps the size of the roster is meant to address this, but its not a hard leap to envision a team having to keep eight or 10 players in quarantine for two weeks of the season with just one positive test or even one suspicion of infection with a raised temp. And Doolittle is right, and its not addressed yet, is what everyone is going to feel if just one player or team employee becomes dangerously ill. Not just for fear of the virus spreading, but MLB having to answer the question as to why it thought a baseball season was worth having if it meant possibly killing even one person.

Doolittles other concerns about players with compromised immune systems or long-standing conditions, as well as family members such as his own wife, basically are addressed in the rigorous and thorough testing and monitoring outlined here. The hope is that all of it will quickly weed out those that have the virus and keep them from the players and staff that are in more danger than most. But obviously, no system is perfect.

See more here:
MLB'S Testing Plan Is Thorough, But Does It Pass The Doolittle Test? - Deadspin

Its no accident that most people tend to sleep at night and are awake during the day. Our sleep-wake cycle is determined by our circadian rhythm, the bodys internal clock. Like old-time clocks, this internal clock needs to be reset every day, and is adjusted by first exposure to light in the morning.

Our circadian rhythms are controlled by multiple genes and are responsible for a variety of important functions, including daily fluctuations in wakefulness, body temperature, metabolism, digestion, and hunger. Circadian rhythm also controls memory consolidation (the formation of long-term memories occurs during sleep); the timing of hormone secretion (for example, the hormones controlling body growth work mostly at night); and body healing.

While the circadian sleep phase typically occurs at night, there are a range of times during which the sleep phase can occur, with some people programmed to sleep from early evening to early morning (known as morning larks), while others stay up late and sleep late (known as night owls). In addition to determining the timing of their sleep, a persons circadian tendency can also affect their choice of emotional coping skills, such as assertiveness or rationalization, and their predisposition to psychological disorders.

An irregular circadian rhythm can have a negative effect on a persons ability to sleep and function properly, and can result in a number of health problems, including mood disorders such as depression, anxiety, bipolar disorder, and seasonal affective disorder.

A recent study suggested that the night-owl type might have a greater predisposition to psychological disturbances. The authors found that the different circadian types were likely to have different coping styles to emotional stressors, and the ones adopted by the morning larks seemed to result in better outcomes and fewer psychological problems. This was a correlational study, so the reason for adopting different styles wasnt explained, but this study emphasizes the great impact circadian rhythms have on health and functioning.

Most of the evidence on the relationship between mood problems and circadian rhythm comes from studies of shift workers, whose sleep periods are out of sync with their circadian rhythm. Multiple studies show an increased prevalence of depression in night-shift workers. One meta-analysis showed that night-shift workers are 40% more likely to develop depression than daytime workers. Conversely, circadian rhythm disturbances are common in people with depression, who often have changes in the pattern of their sleep, their hormone rhythms, and body temperature rhythms.

Symptoms of depression may also have a circadian rhythm, as some people experience more severe symptoms in the morning. The severity of a persons depression correlates with the degree of misalignment of the circadian and sleep cycles.

Many successful treatments of depression, including bright light therapy, wake therapy, and interpersonal and social rhythm therapy, also directly affect circadian rhythms. (For the impact of circadian rhythm on the occurrence and treatment of depression related to bipolar disorder, please see this blog post on light therapy for bipolar disorder.)

Misalignment of the circadian rhythm may also provoke anxiety. Shift work results in a sleep disorder when your nighttime work shifts affect your ability to fall asleep and stay asleep, causing you to have excessive sleepiness during the day that in turn results in distress and affects your ability to function normally. Nurses with shift work disorder have increased anxiety scores on questionnaires. In a study on jet lag, in which travel changes the time of the external environment so that it is no longer synchronized with the internal clock and disrupts sleep, travelers had elevated anxiety and depression scores.

In seasonal affective disorder, people feel down and depressed in the winter months. Researchers believe this is due to changes in circadian rhythms as a result of seasonal changes in the length of daylight. People with seasonal affective disorder feel better using artificial morning light to realign their circadian rhythm with their sleep-wake cycle.

There is no way to change your circadian type since it is genetically determined, though there is some natural change that occurs during your lifespan. For example, our circadian sleep phase tends to shift later during adolescence (more owls) and advances earlier as we age (more like the lark).

If you find that your circadian sleep phase is out of sync with your desired schedule, you can either shift your social life to match your circadian rhythm, or try to shift your circadian rhythm to match your social life. It may be easier to try to shift your work and social life to your circadian rhythm: an example would be a person who has a delayed circadian rhythm and likes to sleep late and wake up late switching from a job with a 7 AM start time to a job which allows him or her to start working later around 10 AM. The other option would be talking to a sleep physician and doing ongoing work to try to shift your circadian rhythm to match your work and social life to an earlier wakeup time.

In general, the best way to improve your mood is to get a good nights sleep by matching your circadian rhythm to your sleep-wake cycle. Exposure to light in the morning helps synchronize the clock. Exposure to bright light at night, including bright artificial lights and screen time on laptops, tablets, and phones, can cause disruption in circadian rhythm and may contribute to worsening mood and negative consequences for health.

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Why your sleep and wake cycles affect your mood - Harvard Health Blog - Harvard Health

KARLA ANDERSON

Stay-at-home orders during this pandemic, have led to many long hours sitting in front of a computer at an unfamiliar desk or your kitchen table as you work from home or homeschool your kids. Then, you retreat to the couch to hide from the news only to binge-watch an entire Netflix series without getting up from your seat. A sedentary lifestyle isnt healthy, and it could put you at increased risk for developing a blood clot such as a deep vein thrombosis (DVT).

WHAT IS A DVT?

A blood clot is a clump of blood that has changed from a liquid to a gel-like or semisolid state. Clotting is a necessary process that can prevent you from losing too much blood in certain instances, such as when youre injured or cut. When a clot forms inside one of your veins, it wont always dissolve on its own. This can be a very dangerous and even life-threatening situation.

A blood clot in a large vein, usually in your leg, is called a deep vein thrombosis. A DVT can partly or completely block the flow of blood through the vein (causing swelling of the area below) and can move or break off and travel to the lungs. When the clot moves to the lungs its known as a pulmonary embolism and can cause death. A pulmonary embolism requires immediate medical attention.

When you sit for a long period of time, the blood flow to your legs slows down, and when your legs are still and hanging down, blood tends to pool in the muscular beds of the calf. These factors can make it easier for a clot to form and increase your risk for DVT.

SYMPTOMS OF A BLOOD CLOT

Many people that form a DVT never notice any symptoms. Symptoms include:

Swelling of your leg or arm

Pain or tenderness not caused by an injury

Skin that is warm to the touch, with swelling or pain

Redness of the skin, with swelling or pain

As mentioned, individuals with a DVT are at an increased risk for a pulmonary embolism. If you have difficulty breathing, chest pain that worsens with a deep breath, cough blood, or a faster than normal or irregular heartbeat, seek immediate attention.

PREVENTING BLOOD CLOTS

The good news is that blood clots can be prevented and treated if you understand your risk factors and get treatment quickly. Risk factors include:

Advanced age

Birth control methods that contain estrogen or hormone therapy

Cancer and cancer treatments

Chronic diseases such as heart and lung conditions, or diabetes

Family history of blood clots

Hospitalization for illness or surgery

Obesity

Severe trauma, such as a car accident

Smoking

Sitting too long, especially with legs crossed or confined to bed/wheelchair

Your physician will decide what treatment is best for you based on factors such as age, overall health, medical history, extent of the condition and symptoms. Treatment may include any of the following:

Medications such as blood thinners or clot-dissolving medications

Vena cava filter inserted to catch clots, usually only recommended for patients unable to take medication and blood thinners

Simple lifestyle modifications can help reduce your risk. Some simple tips to keep your blood flowing include:

Take short walk breaks as often as you can. Try taking a phone call on the go or using a headset so you can move freely around the home.

Try chair exercises. Simple leg raises, ankle flexing, and calf raises are low-impact ways to keep blood circulating.

Make time for play. When your work is done, include time to get active. Go for bike ride, walk with your family, or even play hide-and-seek with your kids in the yard its all about movement.

Its important that you understand how your lifestyle plays a role in your health. Talk with your doctor about your risk for blood clots and what you can do to prevent them.

Karla Anderson, MD, is a vascular surgeon with UPMC. She sees patients at the Heart & Vascular Institute, 740 High St., Suite 3001, Williamsport. For more information on blood clots and vascular health, visit UPMCSusquehanna.org/Vascular.

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Taking vitaminsseemed much more exciting when we were children. From the Flintstones brand to fruity liquids to gummies, getting your nutrients was much more of a treat than a task. Cut to two decades later, and vitamins are way less alluring. The good news is that gummies aren't just for kids anymorein fact, adult gummies have been on shelves for a long time, and their increasing popularity has encouraged more brands to jump on the bandwagon, making vitamins an enjoyable part of our day once again. Below, we interviewed a few top nutritionists and wellness experts and asked them to share the best gummy vitamins.

Take a look at what they had to say below.

Vitafusion Women's Supercharged Multi ($10)

"Vitafusion's SimplySupercharged Multivitamin is a good one," says Alissa Rumsey, MS, RD, founder of Alissa Rumsey Nutrition and Wellness. "You only need to take two gummies a day, and it only has three grams of sugar. It also has the simplest ingredients in the vitamin as well as having a good amount of vitamin D and B. Vitamin D is especially good for the winter months and for people who do not get a lot of sun on a daily basis."

Nature Made Vitamin C ($18)

"I prefer Nature Made gummy vitamins," says Lisa Moskovitz, RD, CDN. "They are USP verified, which means they are tested and meet specific requirements set out by the United States Pharmacopeia."

Olly Flawless Complexion ($14)

The Olly brand utilizes the research and savvy of naturopathic physician Taryn Forrelli, ND, who says that theseskin-geared gummies "deliver purifying antioxidants and minerals to support cell detox, hormone health, and proper metabolism, plus a concentrated botanical blend of spearmint, Aronia berry, and dandelion."

Hum Nutrition Hair Sweet Hair ($25)

Sarah Greenfield, RD, loves theseHum gummies because of their proven ingredients. "Some key nutrients include biotin, or B7, which helps the body break down proteins needed for hair growth," she explains. "One study found women experiencing hair loss had a biotin deficiency and adding biotin supplements helped increase hair growth. Zinc plays a role in immune function and also helps maintain the health of hair follicles, leading to the growth of healthier hair.Fo-ti, a Chinese herb is included to help decrease graying by increasing melanin (hair pigment) production."

Story continues

Nordic Naturals Omega-3 Gummy Fish ($30)

WhileAmy Shapiro MS, RD, CDN, advocates forgummy vitaminsprimarily for children or adults who have trouble swallowing pills, she's a fan of theNordic Naturals brand for gummies, especially its omega-3 blend. It's ideal for those with picky palates or vegetarians (eggs and fish like salmon, herring, and mackerel are high in omega-3).

Rainblow Light Rainbow Light Sunny Gummies ($27)

Shapiro is also a fan of the brand Rainbow Light and recommends its gummy varieties. They're totally natural with no artificial flavors, colors, or preservatives.

MyKind Organics Women's Multi Organic Fruit + Vitamin Chews ($25)

"I generally stay away from recommending gummies to clients as nutritional supplementation because many brands are actually packed with artificial ingredients and loads of sugars. However,Garden of Life brand makes the cleanest organic and non-GMO gummies on the market! Not to mention, it makes a variety for men, women, and kids that are loaded with necessary vitamins and minerals. Well done, Garden of Life!" says Dana Kofsky of Wellness Styled.

SmartyPants Adult Complete Daily Gummy Vitamins ($21)

"I absolutely adore SmartyPants gummy vitamins!The brand isorganic, sustainable, taste amazing and are family-owned.It makes it oh so easy to live sustainably by using post-recycled materials inits bottles in an effort to do itspart in protecting our planet. It is so important to trust in a brand and know that you are helping the planet along the way. SmartyPants has truly been an amazing part of me and my kids' daily routine for years," says Lo Roxburgh, author and wellness expert also known as the Body Whisperer.

Gem Daily Vitamin Subscription (one month) ($39)

Shauna Faulisi, a holistic nutritionist and founder of Soul Wellness Method in Los Angeles, doesn't recommend gummy vitamins as a first step to a healthy diet, preferring her clients to get vitamins and minerals through vegetables, clean fats, and proteins, and taking specific supplements based on their individualized needs. But she understands there may be limitations: "I know that it's not always possible to purchase and get on a regiment with many different supplements to take based on schedule, access to fresh foods, and monetary resourcesand I think one should embrace whatever added wellness regimen they can bring into their life, large or small, and feel proud about it!" she says. "My go-to recommendation for gummy vitamins are GemThe brand uses dates as a binder and sweetener, along with fiber and omega-filled chia seeds to bind.Gemhasa variety of vitamins and minerals as well as the adaptogen ashwagandha to help ease stress. It also hasone of my favorite anti-aging ingredients, the powerful antioxidant, astaxanthin. Gem is an incredibly well-thought-out daily supplement that uses only the purest, whole food ingredients to get the job done."

Next up: No Lie: These Vitamins Will Make Your Hair, Skin, and Nails Flawless

This post was updated by Sarah Yang.

This article originally appeared on The Thirty

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Nutritionists Say These Are the Best Gummy Vitamins - Yahoo Lifestyle

By Rocky Swift and Christine Soares

TOKYO: In the global hunt for coronavirus treatments, a Japanese antiviral medicine known as Avigan has won plaudits from Prime Minister Shinzo Abe and $128 million in government funding. But it's not the only game in town.

Camostat, a 35-year old pancreatitis drug made by Osaka-based Ono Pharmaceutical Co , has captured the interest of scientists in Japan and overseas with little fanfare or state assistance.The two compounds are among dozens undergoing testing around the globe and illustrate how the race to develop treatments and vaccines is still wide open despite politicians such as Abe and U.S. President Donald Trump promoting the potential benefits of certain drugs.

Gilead Science Inc's remdesivir has pulled into the lead after promising early trial results prompted emergency approval in the United States and Japan. While remdesivir has shown promise in reducing recovery times of hospitalised patients, the search continues for additional treatment options.

Abe's administration has pledged to give away free supplies of the drug, with some 43 countries making formal requests. Fujifilm chairman Shigetaka Komori is a longtime backer of Abe, though the cabinet has denied there is any connection between their relationship and the government's promotion of Avigan.The use of Avigan is decided by doctors and its approval will depend on medical and scientific evaluation in due course, said Fujifilm spokeswoman Kana Matsumoto. "The use of Avigan has nothing to do with the relationship between the Prime Minister and any particular company," she said.

DESTRUCTIVE TO FETUSES

Avigan, known generically as favipiravir, was developed in the late 1990s by a company that was later purchased by Fujifilm as part of its transition from photo businesses to healthcare. The drug works by short-circuiting the reproduction mechanism of certain RNA viruses such as influenza.

Avigan can be taken as a pill, which would make it more accessible than Gilead's remdesivir, currently administered only as an intravenous infusion. But the mechanism that makes Avigan effective against viruses also makes it destructive to the rapid cell growth of fetuses. After being tested against a range of viruses, Avigan was finally approved in Japan in 2014, but only for emergency use against flu epidemics, and it was licensed in China where it has since gone off patent.

Also clinically unproven is a camostat mesylate. Developed by Ono Pharmceutical, most famous for its blockbuster Opdivo cancer drug, camostat is a protease inhibitor that has been used primarily to treat pancreatitis and some types of cancer. But past laboratory and animal tests against SARS-CoV-1 showed it has antiviral functions, and it can be safely administered in high enough doses to match the concentrations that were effective in the lab.

A study published in the scientific journal Cell in March found that camostat blocks an enzyme essential for the entry of the coronavirus into the lungs, drawing researchers' interest. One of them was Dr. Joseph Vinetz, a professor at the Yale School of Medicine, who is ready to launch a clinical trial of camostat.

"It's got a 35-year track record, so it seemed to be a very safe drug," he said. "I said we've got to try it. I'm a physician and we're desperate for anything we can give to people."

Vinetz is still trying to raise money for the trial. "I'm 100% certain that we needed to start this trial a month ago. And we can have a definitive result in a month." Ono launched camostat, known commercially in Japan as Foipan, as a treatment for chronic pancreatitis in 1985 and postoperative reflux esophagitis in 1994. The company is now supplying the drug for COVID-19 studies in Japan and overseas, according to spokesman Yukio Tani.

Itzchak Levy at the Sheba Medical Center in Israel launched a self-funded camostat trial in April. "Up to now we recruited 14 patients and look forward to further recruitment," Levy said. Another trial being carried out at the University of Kentucky is testing whether camostat can inhibit the virus's preferred pathway into human cells, and with hydroxychloroquine - the malaria drug touted by Trump -- also block the back door, boosting the treatment's effectiveness.

Existing science behind camostat's mechanism of action and tolerance in patients "is why we were enthusiastic about its potential," said Elijah Kakani, an assistant professor at the university involved in the research. "However, at this point we need to temper our enthusiasm and be objective in our evaluation of this medication for the problem at hand."

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A tale of two Japanese drugs in tests to fight COVID-19 - ETHealthworld.com

CHICAGO May 14, 2020 (Thomson StreetEvents) -- Edited Transcript of Veru Inc earnings conference call or presentation Wednesday, May 13, 2020 at 12:00:00pm GMT

Veru Inc. - CFO & Chief Administrative Officer

* Mitchell S. Steiner

Veru Inc. - Chairman, President & CEO

Veru Inc. - Director of IR

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

Independent Portfolio Consultants, Inc. - Investment Strategist

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Good morning, ladies and gentlemen, and welcome to Veru Inc.'s investors' conference call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru Inc.'s Director of Investor Relations. Please go ahead.

Samuel Fisch, Veru Inc. - Director of IR [2]

Good morning. The statements made in this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the company's current assessment of the risks and uncertainties related to our businesses. Our actual results and future developments could differ materially from the results or developments in such forward-looking statements. Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the company's product portfolio, risks related to the ability of the company to obtain sufficient financing on acceptable terms we need to fund development and company operations, risks related to competition, government contracting risks and other risks detailed in the company's press releases, shareholder communications and Securities and Exchange Commission filings. For additional information regarding such risks, the company urges you to review its 10-Q and 10-K SEC filings.

I would now like to turn the conference over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO and President.

Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [3]

Thank you, Sam, and good morning. With me on this morning's call are Michele Greco, CFO and CAO; Phil Greenberg, Executive Vice President, Legal; and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Today, we will update you on the clinical development of our drug pipeline and the commercialization of our products as well as provide financial highlights for the second quarter fiscal year 2020.

Here is a brief update on the advancement of the prostate cancer drug pipeline, VERU-111 in prostate cancer. We have made significant progress in the clinical development program for VERU-111, a novel proprietary first-in-class oral-targeted antitubulin agent for men who have metastatic castration-resistant prostate cancer and have also become resistant to a novel androgen blocking agent, enzalutamide or abiraterone, but prior to IV chemotherapy, also referred to as the prechemotherapy stage. Unfortunately, there is a large number of these affected men.

According to published scientific reports, about 15% to 25% of men who have metastatic castration-resistant prostate cancer and started treatment with a novel androgen blocking agent will not respond all to this therapy. And about 75% to 85% of men will initially respond to treatment with an androgen blocking agent but their cancer will start progressing in about 9 to 15 months. So essentially, within 12 months, the majority of these men will have tumor progression. And a new orally available drug with a different mechanism of action that could be prescribed by urologists and medical oncologists, like the investigative drug VERU-111, is greatly needed for these men.

The Phase Ib portion of the Phase Ib/II clinical study enrolled 39 subjects from 7 clinical sites in the United States. A standard 3x3 design was used to establish the maximum tolerated dose to select a recommended clinical dose for the Phase II study and to assess the preliminary evidence of antitumor activity of VERU-111 in men with metastatic castration-resistant prostate cancer, who have also become resistant to at least 1 novel androgen blocking agent.

Oral dosing escalated from 4.5 to 81 milligrams in the 7 days of dosing, followed by 14 days of no drug for each 21-day cycle. After no dose-limiting toxicity was observed in the 7 days of dosing per cycle, the dose was then increased in the next cohort of patients. Additionally, the dosing schedule has expanded at 21 days of continuous dosing per cycle.

As for safety, the maximum tolerated dose of VERU-111 was determined to be 72 milligrams as 3 of 11 men had reversible grade 3 diarrhea, no grade 3 diarrhea was observed at doses of 63 milligrams or less per day. At doses of VERU-111 of 63 milligrams less per day, the most common adverse events were mild to moderate nausea, vomiting, diarrhea and fatigue. There were no reports of neurotoxicity and no neutropenia was observed at 63 milligrams and lower for the continuous oral dosing, daily dosing for a 21-day cycle.

Efficacy or antitumor activity was assessed by measuring serum PSA and by standard imaging with bone and CT scans. In the 8 men that received at least 4 21-day cycles of oral VERU-111 at any dose based upon their 21-day cycle baseline PSAs, 6 of the 8 men, which is 75%, had decreases in their PSA levels; 4 of 8 men had -- which is 50%, demonstrated greater than or equal to 30% decline in PSA; and 2 of 8 men, which is 25%, have greater or equal to 50% decline in PSA.

Based upon the Prostate Cancer Working Group 3 and the Response Evaluation Criteria in Solid Tumors, which is RECIST 1.1 criteria, these are conventional criteria, objective tumor responses we're seen in 2 of 8, which is 25% of patients, in soft tissue and bone, which were partial responses; and 5 of 8 men, 63%, had stable disease. Objective tumor responses and PSA declines lasted longer than 12 weeks. The primary end point used in the pivotal studies, efficacy studies for the treatment of metastatic castration-resistant prostate cancer is median time to cancer progression by imaging, bone and CT scans.

In the current study, the median duration of response or time to cancer progression has not been reached, as 7 of the 8 men are still being treated on the study with an average duration of response of 10 months. The range is between 6 and 14 months. There were an additional 3 subjects on the study that have not yet completed the 4-day -- the 4 21-day cycles. Therefore, there is a total of 10 men that is still being treated on the study.

To better understand the clinical relevance of these preliminary findings, it's important to note that all patients with metastatic castration-resistant prostate cancer at the time of enrollment in the Phase Ib had evidence of disease progression with at least 1 novel androgen blocking agent drug, whether it's abiraterone or enzalutamide. In a contemporary series recently reported in the scientific literature for this similar population of men, the median observed time to cancer progression, while being treated with an alternative androgen blocking agent, was about 3.4 months.

We have already initiated enrolling in an open-label Phase II portion of the clinical trial in approximately 26 men with metastatic castration and a novel androgen blocking agent-resistant prostate cancer prior to and prior to any IV chemotherapy using the recommended dose and schedule that was selected from the Phase Ib, which is the 63-milligram oral daily dosing for a continuous 21-day cycle. We are on track to complete enrollment this quarter.

We have the clinical safety and the antitumor data necessary from the Phase Ib clinical study to move forward to select the patient population, dose and schedule for the Phase III registration trial. We plan to meet with the FDA next quarter to discuss our proposed registration trial design, which is an open-label, single pivotal Phase III to evaluate the efficacy and safety of VERU-111 versus an alternative androgen blocking agent in men with metastatic castrate-resistant prostate cancer, who have developed cancer progression while receiving 1 androgen blocking agent.

These recent clinical results have allowed the company to potentially accelerate the clinical development of VERU-111 for the treatment of metastatic castration and androgen blocking agent of resistant prostate cancer. Consequently, Veru has changed its strategy of investing in an additional Phase II studies of other cancer types to focus on obtaining approval of VERU-111 as quickly as possible by focusing on the study design, obtaining FDA agreement and initiating and completing a Phase III registration trial for this unmet medical need. We look forward to updating everyone on the results of the FDA meeting.

We have strong IP protection for VERU-111. The composition of matter patents are issued, with expiry in 2031 in the U.S., with a possible patent extension to 2036. Method of use patents for prostate cancer in the U.S. are issued and expiry date is in 2031. We have issued composition and method of use patents in the major markets -- major world markets, including EU and Japan.

The prechemotherapy space in men, who have metastatic castration and androgen blocking agent-resistant prostate cancer, is currently one of the fastest-growing unmet medical need segments in advanced prostate cancer. There are currently no FDA-approved drugs for this indication. According to Accuvia, oral drugs like abiraterone and enzalutamide for advanced prostate cancer had over $6 billion in 2018 global annual sales and $3.1 billion in the U.S. Men who have failed these novel androgen blocking agents are the patients that VERU-111 is currently targeting, which we estimate represents a $5 billion annual global market.

In summary, the clinical development objective is to position VERU-111, which has a unique drug mechanism of action as it does not target the androgen receptor, as the next go-to drug in men who have metastatic castration-resistant prostate cancer and who have developed prostate cancer progression while being treated with an androgen blocking agent, like abiraterone or enzalutamide, but prior to IV chemotherapy. An advantage of VERU-111 is that it could be potentially prescribed by not only the medical oncologists but also the urologists, who is the usual physician managing these types of patients. We plan to present the full clinical data set in an upcoming major scientific meeting. These clinical results firmly position Veru as an oncology-focused biopharmaceutical company.

Next, I will update you on VERU-100, our proprietary peptide drug candidate for the treatment of hormone-sensitive advanced prostate cancer, an established multibillion-dollar global market. The target product profile of VERU-100 is commercially and scientifically compelling as having a number of anticipated advantages over currently available androgen deprivation therapies.

VERU-100 is a long-acting gonadotropin-releasing hormone, called GnRH antagonist, designed to be administered as a small-volume subcutaneous 3-month depot injection without a loading dose. As a GnRH antagonist, it is intended to immediately suppress testosterone, with no testosterone surge upon initial or repeated administration and no testosterone micro increases, which may adversely affect patient outcomes, a problem which potentially occurs with the approved LHRH agonist drugs like Lupron, Zoladex and Eligard. Currently, there are no GnRH antagonists commercially approved for treatment beyond 1 month, making VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot, which is an attractive choice for androgen deprivation therapy.

As previously mentioned, we have received agreement from FDA that the development program for VERU-100 may follow an expedited pathway. Based on this FDA input, the company plans to commence a single open-label, multicenter, dose-finding Phase II clinical trial in approximately 35 men, followed by a single open-label, multicenter Phase III clinical trial in only approximately 100 men. Veru is in the process of scaling up GMP manufacturing of drug product to prepare the clinical trial -- prepare for the clinical trial to VERU-100. Given the effects of COVID-19, it will be at least a quarter delay in this program. But otherwise, we expect the company's development program to resume as workers are returning to the GMP facility.

The company intends to submit an Investigational New Drug Application in the second half of 2020, so we can commence the open-label Phase II study by Q4 calendar year 2020. As it is an open-label Phase II study, we will be able to update you periodically on our progress towards reaching the primary end point, the reduction of testosterone to castrate levels in real-time during late 2020 and early 2021. The planned development pathway for VERU-100 agreed upon by FDA represents a lower-cost investment opportunity for a major product that can address the shortfalls of the current $2.6 billion global ADT market.

Our next product candidate in clinical trial is zuclomiphene, a novel proprietary oral nonsteroidal estrogen receptor agonist being evaluated to treat hot flashes, the most common side effect in men on androgen deprivation therapy for advanced prostate cancer and a major reason why men want to stop androgen deprivation therapy. We enrolled 93 men in a multicenter, double-blind, placebo-controlled dose finding study, Phase II study. And we're evaluating 2 doses, 10-milligram and 50-milligram zuclomiphene versus placebo. We reported positive top line interim results a few weeks ago. We determined that the 10-milligram dose was the no-effect dose, and the 50-milligram zuclomiphene demonstrated estrogenic activity and a reduction in the frequency of hot flashes from baseline to day 42.

We also reported on the safety from the current blinded aggregate clinical database from our placebo-controlled trial. Based on the study's interim findings, zuclomiphene appears to be well tolerated. We have not received any reports of gynecomastia, painful breasts or venous thromboembolic events, which are common side effects in men treated with high doses of estrogen.

Because of the continuing effects of COVID-19 and the related strains on the health system and regulatory agencies, we will be delayed in obtaining a face-to-face end-of-Phase II meeting with FDA for the zuclomiphene program in order to obtain agreement on the Phase III clinical program design that will be acceptable for approval. We will provide details of the design and timing of this study after we have our FDA meeting. Veru estimates that the peak U.S. revenue potential for zuclomiphene citrate to be between $580 million to $639 million. Currently, there are no FDA-approved drugs for this indication.

Although Veru is focused in prostate cancer and oncology, due to the urgency of the current global pandemic and the fact that VERU-100 has the potential to treat both SARS-CoV-2 infection and the associated reactive, severe lung inflammation in COVID-19 patients at risk for acute respiratory distress syndrome, the company is compelled to pursue this COVID-19 indication even though this indication is not the primary focus of our company. Drugs that target microtubules have broad antitumor -- antiviral activity by disrupting the intracellular transport of viruses, such as SARS-CoV-2, along the microtubules.

Microtubule trafficking is critical for viruses that cause infection. Furthermore, microtubule depolymerization agents that target alpha and beta tubulin subunits of microtubules, like a drug called colchicine, also have strong anti-inflammatory effects, including the potential to treat the cytokine-release syndrome, also known as the cytokine storm, which is induced by the SARS-CoV-2 viral infection that seems to be associated with the high COVID-19 mortality rates.

VERU-111 is an oral, first-in-class microtubule depolymerization agent that targets the colchicine binding site of alpha and beta tubulin subunits to inhibit microtubules. The company met with the FDA and has received agreement on the clinical development of VERU-111 as a potential dual, antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program Coronavirus Treatment Acceleration Program, CTAP. As reported yesterday, FDA granted Veru commission to proceed with a Phase II double-blind, randomized 1:1 placebo-controlled clinical trial evaluating daily doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients. There'll be 20 in the VERU-111 and 20 in the placebo subjects, and these are subjects that tested positive for SARS-CoV-2 virus and are deemed to be at high-risk for acute respiratory distress syndrome.

The primary efficacy end point will be the proportion of patients that are alive and without respiratory failure at day 29. Secondary end points will include measured improvements on the WHO disease severity scale. It's an 8-point ordinal scale, which captures the COVID-19 disease symptoms and signs, including hospitalization, to progression of pulmonary symptoms, to mechanical ventilation as well as death. The study is expected to commence in 2 weeks. We're excited about the potential for VERU-111 to treat both the viral infection and potential for -- to treat both the viral infection and the inflammatory response caused by the virus. The Phase II primary end point -- this is critical, the Phase II primary end point is being alive without respiratory distress is a clinically meaningful one.

Because of the urgent need for effective and timely therapeutics to combat COVID-19, the company has applied for significant grant funding through both the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, called BARDA, and the Defense Advanced research Projects agency of the U.S. Department of Defense, called DARPA, to expedite the clinical development of VERU-111 for COVID-19.

The coronavirus pandemic continues to paralyze the economy and threaten lives across the world. An effective drug to treat COVID-19 is still desperately needed. And this Phase II study will expeditiously determine whether VERU-111 has efficacy and safety against COVID-19. There's really no downside to conducting this small study, especially as we get the nondilutive funding. And if VERU-111 has efficacy, the upside is substantial for patients.

Veru's ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs in large markets is being substantially supported by investments from 2 commercial sources of revenue: the FC2 Internal Condom as well as PREBOOST Roman Swipes, which is a 4% benzocaine wipe for premature ejaculation. The company also expects revenues from TADFIN, which the NDA is expected to be submitted in late 2020, early 2021, which will provide additional resources to support the company's clinical development program. As you can see from the earnings release, in Q2 fiscal year 2020, we continue to have significant growth in revenue and gross profit from these commercial products.

Although Ms. Greco will cover the detailed financial result highlights in a few moments. I would like to make a few comments. We again have the pleasure of reporting robust growth in fiscal year 2020 and expect further increases of FC2 sales in both the public sector and prescription sales in the U.S. for the rest of the year. We had a $7 million -- we had $7 million in revenue from the prescription business for Q2 fiscal year 2020 compared to $2.6 million for Q2 fiscal year 2019, an increase of 168%. In fact, to give you a sense of the growth trajectory for all of fiscal year 2019, we sold 159,000 FC2 prescribed units. And for just the first quarter -- first 2 quarters of fiscal year 2020, we sold 171,891 FC2 prescribed units.

Focusing on the Veru's commercial segment, which is made up of FC2, PREBOOST Roman Swipes and drug commercialization costs, we have net revenues increase in Q2 fiscal year 2020 to $9.9 million compared to $7 million in Q2 fiscal year 2019, which is up 43%. Gross profits for Q2 fiscal year 2020 was $7.4 million compared to $4.6 million in Q2 for fiscal year 2019, which is up 61%. In fact, our gross margin climbed to 75% of net revenues from 66%.

Our operating income from this segment significantly increased to $6.2 million from $2.8 million. Net revenue for fiscal year-to-date 2020 was $20.5 million compared to fiscal year-to-date 2019 of $13.3 million. This is an increase of 54%. Our income from operations for this segment of the business was $12 million for fiscal year-to-date 2020, up from $6.2 million in fiscal year-to-date 2019, an increase of 94.6%.

As you can see, our base commercial business is doing very well. And as a stand-alone business would be quite valuable, experiencing significant growing revenue and incomes from operations. This continued revenue growth and profit and positive cash flow from this base commercial business has allowed us to substantially invest in the development of our prostate cancer clinical programs, which enhances the entire value of Veru for our shareholders.

We intend to continue this revenue growth trajectory, with not only the current growth of revenues from FC2 and PREBOOST but also from the revenues that we expect to generate from the commercialization of the company's proprietary Tadalafil and Finasteride Combination capsule for the treatment of BPH, called TADFIN. We're collecting 12-month stability data on TADFIN manufacturing batches and expect to submit the NDA by the end of 2020 to just beginning of 2021.

In the United States, we're exploring commercially launching TADFIN through telemedicine channels. As you have seen, we've had great success with our other products using this sales channel. We expect to -- revenues from TADFIN to add substantially to near-term revenues with high gross margins, to existing and growing revenues from FC2 and the PREBOOST Roman Swipes business.

I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michele?

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Michele Greco, Veru Inc. - CFO & Chief Administrative Officer [4]

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Thank you, Dr. Steiner. As Dr. Steiner indicated, we started off the year with 2 great quarters. Let's start our highlight with the second quarter results for the 3 months ended March 31, 2020.

FC2 unit sales totaled $6.9 million compared to $9.8 million in the prior year second quarter. Total net revenues were up 43% to $9.9 million from $7 million in the prior year second quarter. The company reported quarterly sales growth in its U.S. prescription business and in PREBOOST. Net revenue from the U.S. prescription business was up 168% to $7 million from $2.6 million in the prior year second quarter. Gross profit was up 61% to $7.4 million from $4.6 million in the prior year second quarter. Gross margin increased to 75% from 66% in the prior year second quarter. The increase in gross margin is driven primarily by the increase in the U.S. prescription business.

These financial results do not reflect the new tender orders that will be coming from South Africa. We previously announced that we won 75% of the South African tender, representing up to 120 million units over 3 years for the total tender. This translates to approximately 30 million units per year for our company and potentially $10.4 million in revenue per year for a total of approximately $30 million over 3 years. We expect these new orders from South Africa to ship in greater volumes during the third quarter of this fiscal year.

Operating expenses for the quarter increased by $1 million to $7.7 million compared to the prior year second quarter of $6.7 million due to the increase in research and development costs of $1 million. Nonoperating expenses were $644,000 compared to $1.9 million in the prior year second quarter and primarily consisted of interest expense and the change in the fair value of the derivatives liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018.

For the quarter, we recorded a tax benefit of $133,000 compared to a tax expense of $25,000 in the prior year second quarter. The effective tax rate for this quarter of 14% is due to recording a valuation allowance against the net operating loss generated for the quarter in the U.S. The bottom line results for the second quarter of fiscal 2020 was a net loss of $811,000 or $0.01 per diluted common share compared to a net loss of $4 million or $0.06 per diluted common share in the prior year second quarter.

Now turning to highlights of the results for the 6 months ended March 31, 2020. For the first 6 months of fiscal 2020, the FC2 unit sales totaled 17 million compared to 17.2 million units in the prior year period. Total net revenues were up 54% to $20.5 million from $13.3 million in the prior year period. The company reported growth in FC2 sales in the U.S. prescription business and in PREBOOST. Net revenue from the U.S. prescription business was up 158% to $13 million from $5 million in the prior year period.

And just to note, for all of fiscal year 2019, the U.S. prescription revenue was $14.1 million. Net revenue for PREBOOST Roman Swipes was $574,000 compared to $180,000 in the prior year period. Gross profit was up 59% to $14.7 million from $9.3 million in the prior year period. Gross margin increased to 72% from 69% in the prior year period due primarily to the increase in the U.S. prescription business.

Operating expenses increased by $4.4 to $16.8 million compared to the prior year period of $12.4 million driven primarily by the increase in research and development costs of $4 million. Nonoperating expenses were $2.2 million compared to $2.9 million in the prior year period, and primarily consisted of interest expense and the change in the fair value of the derivative liabilities related to the synthetic royalty financing.

For the 6-month period, we recorded a tax benefit of $210,000 compared to a tax expense of $118,000 in the prior year period. The effective tax rate for the 6 months of 4.9% is due to recording a valuation allowance against the net operating loss generated for the 6 months in the U.S. The company has net operating loss carryforwards for U.S. federal tax purposes of $42.7 million with $14.4 million expiring in years through 2038, and $28.3 million, which can be carried forward indefinitely. And our U.K. subsidiary has net operating loss carryforwards of $61.7 million, which do not expire.

The bottom line results for the first 6 months of fiscal 2020 was a net loss of $4.1 million or $0.06 per diluted common share compared to a net loss of $6.2 million or $0.10 per diluted common share in the prior period. The reduction in the net loss of $2.1 million is due primarily to the increase in our net revenues, which is offset by the increase in our research and development costs.

Turning to our balance sheet. As of March 31, 2020, our cash balance was $2.6 million and our accounts receivable were $5.8 million compared to a cash balance of $6.3 million and accounts receivable of $5 million at September 30, 2019. During the 6 months ended March 31, 2020, we used cash of $4.9 million for operating activities compared with using cash of $4 million in the prior period.

Overall, we're delighted to see the continued increases in sales in the U.S. FC2 prescription business and the increasing sales of PREBOOST Roman Swipes to Roman Health Ventures and look forward to increasing sales in the global public sector business in the third quarter. These revenue sources continue to be a source of funds we use to invest in our promising pharmaceutical clinical programs as we continue to transform our company into an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer.

Now I'd like to turn the call back to Dr. Steiner.

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Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [5]

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Thank you, Michele. We have enjoyed yet another strong financial quarter, which has allowed us to significantly advance our clinical programs. In fact, we now have had 10 straight quarters of growth in our FC2 U.S. prescription business. Looking forward to the rest of fiscal year 2020 and early fiscal year 2021, we expect our revenues to continue to be strong and growing towards a record year.

With the improving performance of the commercial business, we believe that we'll be able to substantially invest in the continued clinical development of our prostate cancer and other cancer drug product candidates as well as to submit the NDA and, if approved, commercially launch TADFIN to -- through Internet sales, which would provide even more revenue, adding to the already growing revenue from FC2 and from PREBOOST Roman Swipes. We are creating a very valuable commercial business, which includes both the urology specialty pharmaceuticals and the female health company divisions.

With the new clinical data from the VERU-111 prostate cancer program, we must prioritize and focus our efforts towards the execution of the Phase III registration program for this unmet need in prostate cancer. This begins by obtaining regulatory clarity from both FDA and EMA on the clinical trial design. We have reached an important company clinical milestone that well positions Veru as an oncology biopharmaceutical company.

We anticipate a steady flow of important positive news for Veru over the next few months to a year. One, for VERU-111, our oral selective antitubulin, we will report an open-label efficacy and safety clinical results from the Phase II clinical trials of VERU-111. And we will meet with the FDA and report on the Phase III clinical trial program.

For VERU-100, our novel peptide GnRH antagonist 3-month depot formulation, we will complete GMP manufacturing of clinical supply, we'll submit the IND, and we'll initiate the Phase II clinical trial. With zuclomiphene, our oral estrogen receptor agonist, we will have a face-to-face meeting with the FDA for -- face-to-face and a Phase II meeting with FDA.

We plan to initiate and complete the Phase II clinical program for COVID-19 and subjects of high-risk to acute respiratory distress syndrome. We'll submit the NDA for TADFIN. We would have secured partnerships with some of our drug products. And we plan to continue to demonstrate robust growing revenues for our commercial products FC2 and PREBOOST Roman Swipes.

We're committed to driving shareholder value by transforming Veru into an oncology company. We will initially focus our efforts to providing substantial benefits to prostate cancer patients by developing and commercializing VERU-111 as well as our other oncology products to address unmet medical needs in the management of their disease.

With that, I now open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) The first question comes from Brandon Folkes of Cantor Fitzgerald.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [2]

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Congratulations on all the progress. And on VERU-111, granted you haven't met with the regulatory agencies, could you perhaps just elaborate about how you're thinking about the Phase III design? Anything you can say maybe around the size and number of patients?

And then how are you thinking about what is the hurdle you think physicians in practice will want to see in that Phase III to use VERU-111 in practice? And then, lastly, maybe just on COVID-19. Should we think of this as a potential revenue-generating opportunity for the company? Or is this going to be similar to what we think from other companies, where it's really just a public duty-type thing?

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Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [3]

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Thank you. All excellent questions. So let's talk about the Phase III design for the -- for VERU-111. So what I can do is I can refer you to the ALAPARIB, that's A-L-A-P-R-I-B -- so A-L-A-P-A-R-I-B study that's in front of the FDA as we speak. It's very instructive in terms of how we're thinking about our clinical trial. So this is one I believe will get approved. This is a patient population that's similar to our patient population. These are patients with metastatic castration-resistant prostate cancer that have failed an androgen blocking agent. Some of them had chemo, but just some -- but mostly the same patient population.

And the reason I bring that up is because it is a registration trial, and the FDA has allowed them to use as an active comparator patients that have placed on an alternative androgen blocking agent. So that means if you think of our patient populations, they fail castration, so they're castration resistant. They put on an androgen blocking agent, either enzalutamide or abiraterone, and then they get randomized to alternative androgen blocking agent. It means if they start out with abiraterone, they get put on enzalutamide. If they start with enzalutamide, they get put on abiraterone. That's what I mean by alternative androgen blocking agent, okay?

And that's your comparator arm. The FDA has allowed that in 3 of the nonmetastatic studies that have been approved, and it's being allowed in this study. So that's why we feel pretty good. The end point of that study, just like those other 3 clinical studies were nonmetastatic, is progression-free survival, radiographic progression-free survival or imaging-based progression-free survival. Another way of saying that is when cancer progresses and you can see it on either bone scan or CT scan, that's deemed a failure, okay? They've accepted that, okay?

The active comparator, in this case, is an oral agent that's going after patients -- that ALAPARIB is going after patients that have a genetic mutation, which is really a small segment of the population. That's why we want to be the go-to drug. We want to be the drug that will treat anybody, not anybody that has a genetic mutation. So that's a much bigger market.

And the -- and in that study, interestingly, they hit -- the hurdle they have to hit is in the treatment and then back up, in terms of the trial size, because you can do progression-free survival, imaging-based progression-free survival, sort of 800 patients or 1,000 patients in the study. That study, I think, is about 250 patients. So the range is going to be around the 250 to 300 mark. It's a much smaller study. And quite frankly, it's a shorter study. And the reason it's a shorter study is because the comparator arm, the active control, fails in about 3.4 to 3.6 months. So if you go for a year, you've got 3 of those cycles. And so follow-up is not very long, unfortunately, for the patient. But your benchmark that you're going up against is about 3.4, 3.6 months median progression-free survival and radiographic progression-free survival. And for ALAPARIB, they showed a 7.4-month advantage. And everybody believes it's going to get approved, okay?

So I shared that with you because I think we're going to be very similar to that. I think our trial design -- our trial size will be between 250 and 300. I think we're going to have an end point of imaging-based progression-free survival. I think we'll be able to compare our agent VERU-111 against an alternative blocking -- alternative androgen blocking agent. I think the hurdle that we need to hit is going to be about 3.4 to 3.6 months.

I have comfort to know that in the Phase Ib, the median duration of response is 10 months, with a range between 6 and 14 months. It feels good but, of course, you have to be careful. It is Phase Ib, but that gives you comfort that we should be in good shape from the standpoint of being able to beat that. And that's the kind of design.

So it feels safe because we're not asking the agency to do something new. And -- but it also gives you a sense of why we're excited about going into a Phase III registration program because these patients are around so recruitment should be pretty straightforward. And it's completely an unmet medical need. And there's enough regulatory precedent that we can feel comfortable around trial design.

As it relates to your second question, which has to do with COVID-19. That's nice you're doing it, and you're going to do like Gilead and just kind of give it away and give all the doses to the government and show 3 or 4 days of hospital benefit and move on. Now we're a small company, and we think we have an innovative compound, VERU-111.

Excerpt from:
Edited Transcript of FHCO earnings conference call or presentation 13-May-20 12:00pm GMT - Yahoo Finance

In the past year, it seems politics will leave no rock unturned. Every aspect of our lives is becoming politicized. The NBA. The NFL. Nike. Thanksgiving. Now medicine.

This is even more dangerous than it first appears. Recently, an online video by ER doctors Daniel Erickson and Artin Massihi went viral. They expressed views that differed from the presiding media narrative on COVID-19.

Swiftly, the video was censored by YouTube, and their own professional organizations, the American Academy of Emergency Medicine (AAEM), and the American College of Emergency Physicians (ACEP), released a bizarrely aggressive statement accusing the doctors of financial conflicts of interest without any supporting evidence.

I saw truth in both sides scientific positions, but this statement was very strange from a medical professional organization, especially the personal accusation. Im not aware of any time in modern medical history this has happened.

As a legislator, it smelled of politics. As a physician, it didnt seem right for a professional society to accuse board-certified physicians of expressing their opinion for financial gain without any evidence whatsoever.

If ACEP and AAEM would have left things within the scientific realm, I wouldnt have thought much of it. But they wentfurther.Why? ACEP and AAEM were trying to personally discredit these physicians. And they did so by conjecture.

Our country is in trouble. Mutually exclusive worldviews now hinder the quest for scientific truth. The accelerated politicization of medicine has me more concerned than ever.

Political takeovers have already occurred in other medical societies. Not surprisingly, the first big split was within the OB-GYN specialty over abortion. The American College of Obstetricians and Gynecologists (ACOG) first moved to the left by openly supporting abortion, and in 1973 the American Association of Pro-Life OB-GYNs (AAPLOG) was born. Because of ACOGs increasingly aggressive support of abortion, many pro-life physicians have left the organization. ACOG and AAPLOG cut ties in 2013.

The pediatric medical organizations have undergone a similar split, with transgenderism at the center of debate. The American College of Pediatricians (ACP) has been the target of many attacks from the left due to their position statements on sexuality and transgenderism. The ACP has been labeled an anti-LGBT hate group by the Southern Poverty Law Center. In 2017, as the politics continued rile the medical world, the American Academy of Pediatricians (AAP) suddenly flipped on their position on parental notification for abortion. The AAP is now an LGBTQ lifestyle advocacy group.

My local medical society succumbed to the same political polarization in early 2019 when they voted to endorse a radical pro-abortion bill. As I sat at the table during the debate, a few of us argued that the medical society should stay away from this legislation, and that we should preserve our uniqueness to contribute to society purely from a medical perspective, not a political one.

The council ignored this warning, and voted for the endorsement. After this, I knew I could not continue paying dues to a society that endorsed abortion, so I publicly renounced membership.

Among the many things I love about practicing medicine is that all my patients have the same condition: the human condition. My patients arent Republicans or Democrats. Theyre just people needing help.

Our medical societies used to be fairly politically neutral, and stuck to pure medicine. Now as partisan groups, theyve put medical credibility into a state of crisis: a crisis of legitimacy. If doctors want to use their medical knowledge to further propagate their worldview, they should just go work on a political campaign.

My greatest fear as I observe the leftist takeover of medicine is dehumanization. Leftist ethicists are advocating for human genetic engineering without restrictions all in the name of progress. This technology is flirting with the field of eugenics, leading us deeper down the road to dehumanization of the human person.

Remember the controversial 2016 Super Bowl ad that humanized the fetus? Just a few months prior, the Scientific American published an article entitled, The Truth About Fetal Tissue Research. The article was fraught with subtle politicized language, labelling groups anti-abortion instead of their pro-life identity as well as falsely claiming abortion constitutes only 3 percent of Planned Parenthoods services.

It also mentioned a researcher at UNC-Chapel Hill who tried to humanize a mouse for fetal tissue research, stating Using fetal tissue is not an easy choice, but so far there is no better choice.No better choice than to use humans who were purposefully killed in the name of science. Let that sink in.

Medicine is unraveling, and the crisis of legitimacy in the field has begun. American doctors are not immune to this phenomenon, as political worldview clearly now trumps science. Somehow leftist scientists believe they own the realm of scientific fact. They intend to advance their worldview, and their science has devolved into scientism. After all, the scientific method is about coming to a conclusion, not starting with one.

Many doctors and scientists simply capitulate. Those who dont? Well, we just saw what happened to Drs. Erickson and Massihi. When you speak truth to power in a time of unmitigated tyranny, power will silence and slander you.

This isnt the first time, either. Kenneth Zucker, a psychologist, was recently removed from the program of a transgender conference due to threats of violence and outrage posturing from the other speakers. Open debate is the enemy of dogma.

Its hard to say which is the greater risk to the practice of medicine: doctors influence over policy, or over their patients. Doctors with a leftist ideology have been known to readily recommend sex-change hormones to young children. I know physicians who have seen some of these children whose parents are seeking a third or even fourth opinion. When they are seen by a doctor with a conservative worldview, they receive a different diagnosis and are presented with alternatives to pre-pubescent hormone treatment.

Political wars are won with the battle over education. The left took over journalism schools decades ago, and we can all plainly see the medias bias today. They have successfully infected medical schools as well.

I took the Hippocratic Oath as a medical student. In its original form, this oath explicitly forbids the practices of abortion and euthanasia. Most medical schools now utilize the ever-changing Geneva Convention instead.

We have a crisis of legitimacy in modern medicine. Doctors opinions now come with a large dose of worldview. Our nations leaders would do well to understand that. Our civilization depends on it.

Gregg Schmedes, MD, serves in the New Mexico House of Representatives, representing District 22. He resides in Tijeras, New Mexico with his wife and six children.

View post:
How Becoming A Partisan Weapon Will Destroy Medicine - The Federalist

When it comes to the quest to look forever young, there isnt much that women with maturing skin wont try (vampire facials, breast milk anyone?). But some unique hacks are just a lot more fun than others.

Megwyn White, Director of Education for Satisfyer, a premier maker of satisfaction toys and gadgets, agrees. According to White, orgasms are an inexpensive and effective way to increase your natural glow. And renowned Obstetrics and Gynecology Physician Tosha Rogers seconds that assertion.

According to these experts, here are a four key ways orgasms can keep your skin looking and feeling younger and glowing longer:

1. During an orgasm, a surge of endorphins and oxytocin are released from the brain. These hormones and chemicals regulate and lower cortisol levels, which in turn helps to reduce inflammation and naturally ward off skin ailments. Oxytocin is really known as the cuddle hormone,' says Dr. Rogers. It is the anti-stress, which is why it lowers the cortisol levels, which is the stress hormone. Anything that creates happiness and decreases stress decreases inflammation.

2. Orgasms also help to raise estrogen levels, which supports collagen growth in the body, aiding in the prevention of wrinkles and aging skin. Estrogen also helps to lock in the skins moisture, keeping skin hydrated and plump, according to White.

3. Orgasms facilitatebetter beauty sleepthrough the production of hormones and neurotransmitters, including prolactin and serotonin, which both help toinduce and regulate deep, non-rem sleep. Orgasms help elevate the levels of dopamine in the brain, Dr. Rogers explains. This acts as a satisfied hormone and produces a sense of comfort and euphoria, thus resulting in better sleep.

4. Additionally, sexual activity increases blood flow and circulation, allowing for more oxygen-filled blood cells to reach your face, which can result in a radiant look. Orgasmic expression also increases micro-expressions within the face, supporting the elasticity and tone of tissues which might otherwise be caught in contractive patterns which can result in wrinkle formation, says White.

So whether youre getting it on with a partner, or quarantined solo, you can still use this lesser explored option to get your skin together. And while anything can be bad for you in excess, theres very little worry that youll overdo it in this instance.

Overstimulation is absolutely possible when it comes to the body, White explains. That being said, the female body is capable of having multiple orgasms, with a shorter refractory (recovery) period in between climaxes. If a woman is capable of multiple orgasms, she shouldnt worry about the amount, but rather whether the stimulation itself feels overly aggressive or intense. If she experiences any pain or discomfort, its important to take a break.

View post:
Here's Why You Might Want To Add Orgasms To Your Daily Skin Care Routine - Essence

MORRIS PLAINS May 12, 2020 (Thomson StreetEvents) -- Edited Transcript of Immunomedics Inc earnings conference call or presentation Wednesday, May 6, 2020 at 9:00:00pm GMT

Immunomedics, Inc. - Executive Chairman

* Brendan P. Delaney

Immunomedics, Inc. - Chief Commercial Officer

Immunomedics, Inc. - Senior Director of IR

Immunomedics, Inc. - CFO & Chief Business Officer

* Nicholas M. Abbott

* Philip M. Nadeau

Good afternoon, ladies and gentlemen. Thank you for standing by. As a reminder, this call is being recorded. Today is Wednesday, May 6, 2020. At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics.

Chau Cheng, Immunomedics, Inc. - Senior Director of IR [2]

Thank you, Jimmy. Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties, and therefore, actual results could differ materially from those expressed or implied on this call. Factors that could cause such a difference include the uncertainty associated with pharmaceutical development and the regulatory approval process as well as difficulties in forecasting sales, revenues and expenses.

More information about the risks and uncertainties faced by Immunomedics, Immunomedics business contained with the caption Risk Factors under -- included in the company's periodic report filed with the Securities and Exchange Commission, including the company's annual report on Form 10-K for the year ended December 31, 2019.

With us on the call today with prepared remarks are Dr. Behzad Aghazadeh, Executive Chairman, and Usama Malik, Chief Financial Officer and Chief Business Officer. Also on the call for Q&A are Harout Semerjian, President and Chief Executive Officer; and Brendan Delaney, Chief Commercial Officer. Following the prepared remarks, we will open the call up for questions. Thank you. Behzad?

Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [3]

Thank you, Chau. Good afternoon, everyone, and thank you for joining us. We entered 2020 with strong momentum. While the first quarter was primarily focused on completing the FDA review and executing on ongoing priorities, the last several weeks have been monumental for the company. The hard work, commitment and dedication of our colleagues at Immunomedics over the last 3 years have culminated into a series of accomplishments that establish us as a fully integrated commercial biopharmaceutical company. The approval of TRODELVY by the FDA exemplifies our commitment to deliver breakthrough therapies to help transform the lives of those with hard-to-treat cancers.

This commitment is further demonstrated by our commercial team. We were successful in making TRODELVY available to people with mTNBC shortly upon FDA approval. As noted in our press announcement this past Monday, TRODELVY was shipped to our specialty distributors last week, and the first patient was treated with commercial product exactly a week ago today, exactly one week after FDA approval.

Equally importantly, our regulatory and market access teams have already completed a National Drug Rebate Agreement with The Centers for Medicare & Medicaid Services. As a result of our teams mobilizing quickly, for Medicaid specifically, states are now generally obligated to cover TRODELVY as of July 1, 3 months ahead of our scheduled time line and a big win for Medicaid patients. The rebate agreement is also prerequisite for Medicare.

Another key event this year is the early halting of this Phase III ASCENT study due to compelling evidence of efficacy across multiple endpoints. We have begun the process of cleaning the database, which will result in database lock and ultimately the unblinding of the study. Top line readout remains on track for mid-year 2020.

We also look forward to the top line data from the first cohort of 100 patients who were previously exposed to platinum-based and PD-1 and PD-L1 inhibitor therapies in the TROPHY U-01 study of patients with metastatic urothelial cancer. As previously disclosed, these data could potentially support a BLA submission for accelerated approval to the FDA, which has recently granted TRODELVY Fast Track designation in this indication.

For the second cohort of patients who are platinum ineligible and have progressed after prior checkpoint inhibitor therapy, an abstract containing early results has been accepted for poster presentation at this year's ASCO virtual meeting. An additional abstract from the Phase I/II study of TRODELVY in patients with previously treated metastatic endometrial cancer has also been accepted for poster presentation at the same conference.

In other clinical development, we have entered into a clinical collaboration with the Dana-Farber Cancer Institute and Merck to study the combination of TRODELVY with pembrolizumab, an antiPD-1 antibody in 2 separate Phase II studies. The first study involves approximately 110 patients newly diagnosed with PD-L1 negative mTNBC. These patients will be randomized to receive the combination of TRODELVY and pembro versus TRODELVY alone. The same combination of TRODELVY and pembro will be used in the second randomized study in approximately 110 hormone treatment and chemo-refractory patients with PD-L1 positive hormone receptor, positive HER2-negative metastatic breast cancer. Both studies will have PFS, or progression-free survival, as the primary end point. Overall survival, overall response rate, duration of response and clinical benefit rate will be used as secondary end points.

Financially, the company completed an oversubscribed public offering, and we have added approximately $465 million to our balance sheet. Furthermore, the approval of TRODELVY triggered a $60 million contractual milestone payment from Everest Medicines, our partner in China, who recently announced the approval by the Chinese regulatory authority to initiate a pivotal Phase III study of TRODELVY in mTNBC in China, which they begin to plan -- which they plan to begin in the first half of 2020.

At this exciting inflection point of the company's growth, I'm also pleased to announce that Dr. John Stubenrauch has been appointed Senior Vice President, Global Head of Manufacturing. John is a seasoned executive with decades of experience with companies like AstraZeneca and Merck. He brings a strong foundational background in global commercial manufacturing. John will spearhead the initiatives that continue to scale our global supply chain, ensure supply continuity and focus of cost of goods optimization. With John's new role, Dr. Morris Rosenberg is stepping down as Chief Technology Officer with the company, which will be effective later in May.

I would like to thank Morris, who was seminal in helping us develop our initial clinical and commercial supply chain and manufacturing processes. Morris will be pursuing a new opportunity closest to his home in the Pacific Northwest that is focused on new product development. We wish him the very best in his future endeavor and will keenly follow his progress. Thank you, Morris. I know you're listening.

Usama will now go over the financials.

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Usama Malik, Immunomedics, Inc. - CFO & Chief Business Officer [4]

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Thank you, Behzad. As in the past, please refer to our quarterly filing as well as our earnings release this afternoon for additional details of our results.

Total costs and expenses were $82 million for the 3 months ended March 31, 2020, compared to $79.6 million for the comparable quarter ended March 31, 2019. The increase was primarily due to a $4.3 million increase in R&D expenses and a $0.2 million increase in sales and marketing expenses, partially offset by a $2.1 million decrease in G&A expenses.

Interest expense was $13.5 million for the 3 months ended March 31, 2020, compared to $10 million for the comparable quarter March 31, 2019. The increase was due primarily to changes in the fair value of our debt balances as a result of the agreement with Royalty Pharma. Net loss was $93 million or $0.44 per share for the quarter ended March 31, 2020, compared to a net loss of $87.3 million, also $0.46 per share for the comparable quarter ended March 31, 2019.

As of March 31, 2020, the company had $540 million in cash, cash equivalents and marketable securities. On May 1, 2020, the company closed on its previously announced underwritten public offering of common stock with net proceeds of approximately $464 million. The number of outstanding shares after the capital raise were 231 million, and the fully diluted count was 242 million.

As Behzad alluded to earlier, we expect to receive $60 million from Everest Medicines triggered by FDA approval of TRODELVY. We believe our projected financial resources are adequate to support the commercial launch of TRODELVY in the United States in mTNBC and continue to expand the clinical development programs for TRODELVY, invest in the broader clinical development of the ADC platform, continue to scale up of manufacturing and manufacturing process improvements and general working capital requirements.

This concludes our first quarter 2020 financial results, and I will pass it back to Behzad.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [5]

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Before we open it up for questions, a few words to update on the impact the coronavirus pandemic is having on our business. With the shelter-in-place recommendations taking effect, we quickly move to remote access and work from home for all nonessential personnel. We have implemented stringent on-site monitoring and as much as feasible, undertaken social distancing measures for essential on-site staff, who predominantly are comprised of colleagues in our manufacturing and quality operations. As a result, thankfully, operations have been minimally impacted to date.

With respect to our ongoing clinical trials, we announced in late March that we were pausing enrollment of new patients and activation of new sites. While it is too early to assess the precise extent of disruption to the conduct of our trials, we are confident that the impact will be manageable. In particular, the pivotal Phase III ASCENT study, which completed enrollment in mid-2019, was halted following the independent DSMC recommendation. We anticipate very limited impact from the pandemic.

The pivotal 100-patient cohort of platinum eligible urothelial cancer in the TROPHY U-01 study also fully enrolled as of October 2019 and had significant follow-up already completed pre-COVID-19. So again, we do not anticipate significant impact.

And finally, following persistent requests from investigators, the Phase III TROPiCS-02 study of TRODELVY in hormone-receptor positive HER2-negative metastatic breast cancer will be resuming enrollment beginning later this month at select sites that have been carefully vetted for their ability to ensure normal clinical trial operations and patient safety.

On behalf of all of my colleagues at Immunomedics, our thoughts and well wishes are with those impacted by the coronavirus pandemic. Further, I would like to express our thanks to the workers who are providing essential services and helping mitigate the disruption to our lives as well as recognize the medical personnel who are combating this disease on the front lines. I would also like to extend my special gratitude to my colleagues at Immunomedics who continue to work tirelessly towards fulfilling our mission of delivering these breakthrough medicines to patients in need. As the lines between the days of the week, the evenings and nights and the weekends have blurred, we find ourselves often putting in even more hours than prior to the outbreak. I understand this phenomena is playing out across our sector and no doubt also beyond. May this all pass soon.

Operator, please open the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Phil Nadeau with Cowen and Company. Once again, our next question comes from Phil Nadeau with Cowen and Company.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [2]

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Operator, we're getting e-mails from folks that are having hard time getting on the Q&A line. Is there -- can you check the lines?

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Operator [3]

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(Operator Instructions) The next question in the queue comes from Michael Schmidt with Guggenheim.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [4]

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Operator, I have a note here that says there are some issues with the dial-in. All sound has dropped.

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Operator [5]

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One moment, please. Testing audio for now. The next question in the queue is -- goes to Michael Schmidt with Guggenheim.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [6]

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All right. Can you hear me?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [7]

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Yes, we can Mike. Well, I don't know how much of what we have to say you heard.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [8]

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Yes, I don't know. I just hear the operator. Well, anyway, so why don't I just ask a question? The one I had was on TROPiCS-02. Can you -- really appreciate the comments you made on enrolling the study and the investigator enthusiasm. We've gotten some questions really on understanding the read-through to the successfully of this study from the ASCENT trial? And maybe if you could just help us understand the timing potentially of the interim analysis that you've talked about, which is based on response rate? And also help us understand how we should think about potential benchmarks here on the control arm in this trial?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [9]

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Sure, Michael. Thanks. Look, we haven't provided timing on when the interim might occur, and that was even before the coronavirus pandemic took hold. And it's really too early to judge exactly what happens from here on. Up until the time when we stalled the enrollment or stopped initiating new study sites, we were enrolling extremely well. And so once we resume here, hopefully, we can regain momentum pretty quickly, and that will then inform us when we would take that interim. And as we get closer, we'll certainly communicate the time lines. But my hope is that the delays or disruptions will be very limited and entirely manageable.

With respect to the benchmark, what we generally said is, obviously, these are distinct patient populations with triple negative, on the one hand. On the other hand, in the very late-line and refractory setting, where we're studying this drug in TROPiCS-02, we're told by the physician community that the patient population presents themselves with a very similar outlook to the triple-negative community. And the chemo options available to them, in fact, very much the same ones that they would be using in the triple-negative opportunity -- setting. And those are exactly what comprised the control arm, which is cap, gem, eribulin and vinorelbine.

So as a result, my expectation would be -- and based on some literature work that we've done, obviously, all retrospective, albeit some of them are more recent contemporaneous study, I would expect response rates on the order of high single digit, low double digit. And I would expect duration of responses of perhaps 3 or so months, very much similar to the triple-negative opportunity. Now that is, I want to heavily caveat that. It's based on literature and the feedback we're getting. And obviously, this is why we're running the study. But those are generally the benchmarks I would use, which is why I'm hopeful and encouraged by this assessment by the DSMC on ASCENT that it will hopefully also translate over into what to read it -- what TROPiCS-02 will read out as.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [10]

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Great. Then maybe just a question on TRODELVY and the initial experience. Now I realize it's only been a short amount of time since the drug's been on the market. But just wondering if you could just share a little bit of initial feedback and whether the initial experience has met your expectations so far?

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Brendan P. Delaney, Immunomedics, Inc. - Chief Commercial Officer [11]

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Yes. Brendan Delaney here. Yes. So I would say in a nutshell so far so good. It's early, as you recognize. But I think we manage the launch, especially in these first 2 weeks on almost an hourly basis, and we're meeting all the tactical implementation and things from that perspective. So certainly, internally, I think we're meeting all our guidelines. I think it was important as we announced that the drug was available within days, which was an important kind of milestone that we are holding ourselves to because we know patients are waiting. And so, so far, so good I would say, I think the feedback from physicians, as you can imagine, physicians are excited for their patients, obviously, but the reaction to the prescribing information and the support services and top to bottom, what we've put out there is pretty well received so far. So it's early, as I said, but so far, so good. We're pleased.

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Operator [12]

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(Operator Instructions) Our next question comes from Peter Lawson with Barclays.

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Peter Richard Lawson, Barclays Bank PLC, Research Division - Research Analyst [13]

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Congratulations on the progress. As we think about the launch, what type of metrics do you anticipate providing going forward? And kind of the milestones you're setting yourself internally, how are you kind of viewing a successful launch? And I guess that's particularly pertinent if we think about in this time of kind of social distancing.

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More here:
Edited Transcript of IMMU earnings conference call or presentation 6-May-20 9:00pm GMT - Yahoo Finance

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Canberra: Six weeks after shutting down swathes of the economyto contain the coronavirus, Australia is preparing to relax its lockdown on Friday. There could be a cost new clusters of infections just as the southern hemisphere heads into winter.

Closing restaurants, cinemas and pubs and urging people to largely stay at home have seen the daily rate of new infections plunge to less than 0.5% from 20% about a month ago. Along with extensive testing and contact tracing, the restrictions have bought Australias health system time to prepare for new outbreaks, as Prime Minister Scott Morrison looks to reboot the crippled economy.

The country of 25.7 million people, which had recorded 6,875 cases and 97 deaths as of Wednesday, will be among the first developed nations to test the resilience of its health system by lifting restrictions just as the weather turns colder. Morrison, whos heralded his governments success in flattening the curve, says the health system is in a good position to cope as he now turns to resuscitating the economy.

When we move and start to ease some of these restrictions, of course you will see numbers increase in some areas, you will see outbreaks occur in other places, Morrison told reporters this week. What matters is how you deal with it, and how you respond to it.

While seasonal flu often flares in winter in temperate climates, scientists are still investigating whether temperature plays a role in the coronavirus outbreak. Australias experience may offer clues to what may happen a few months from now in the northern winter.

Australia has so far avoided thescale of sickness and deaththats ravaged countries including the U.K., U.S. and Italy. Peter Collignon, an infectious diseases physician and professor at the Australian National University Medical School, says Australias handling of the outbreak has put it in probably the best position in the world.

We closed borders very early, have had strong quarantine measures, traced just about every case and convinced the vast majority of Australians to adhere to social-distancing restrictions, Collignon said. Of course, the virus hasnt been eliminated, so we need to avoid thinking things will quickly return to business as usual.

In late January, Morrison announced the first of a string of border controls and enforced quarantine measures to limit and test arrivals from virus hotspots. He closed the nation to non-residents on March 19. Most Australian states and territories also imposed their own border restrictions.

Health authorities have ramped up testing and contact tracing. According toWorld Economic Forum data, as of April 26 the nation had conducted 19.9 diagnostic tests for Covid-19 per 1,000 people, compared with 15.6 tests in the U.S., 9.9 tests in the U.K and 1.8 in Japan. Some 5 million people have downloaded mobile-phone software designed to help trace coronavirus infections, though the government says thats still not enough for it to be effective.

In the past six weeks, Australia has also ramped up the number of intensive-care unit beds, most of which are currently idle. Initial shortfalls of personal protection and medical equipment have, in the main, been identified and alleviated.

According to Collignon, the island continent has also benefited from its geographic isolation and the fact that its population mainly lives in suburban or regional areas, rather than in crowded cities. Still, hes urging the government to not wind backsocial-distancing restrictions, particularly for mass gatherings, until after winter.

Theres some basic principles that we cant compromise too much, particularly as winter is coming, because theres a risk that this will jump up and bite us again, he said.

Also read: Testosterone-reducing hormone therapy could help protect men against Covid: Italian study

At the heart of Australias early success has been the cooperation between Morrisons federal government and the eight state and territory governments, which have put aside political rivalries to largely work in unison. Some states, which have seen days without new infections, have already started to relax social-distancing measures allowing picnics, water sports,hikingin national parks and reopening schools.

But there have been missteps. The most populous state of New South Wales and federal authorities fell into a blame game over why thousands of passengers were allowed to disembark theRuby Princess cruise shipin Sydney in March, even through 13 people on board suffered flu-like symptoms. Hundreds of cases across the nation and at least 20 deaths have been linked to the cruise ship.

The lockdown has taken a heavy economic toll: unemployment is poised to double by July to about 10% and the nation is veering toward its first recession in almost three decades. With restrictions costing the economy an estimated A$4 billion ($2.4 billion) a week, Morrison is keen to relax measures and has been drafting Covid-safe guidelines to help businesses return to work.

But the risks are clear. A cluster of almost 50 cases at ameat processing plant in Victoria stateis a reminder of how outbreaks can emerge and potentially get out of hand, particularly with winter approaching.

Its a very sobering reminder that if the government and the private sector want to get the economy back to some kind of normality, it will probably come at a cost, said Mary-Louise McLaws, an infectious diseases expert at the University of New South Wales.-Bloomberg

Also read: WHO wants to go to China again as search for origin of coronavirus heats up

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Winter is coming for Australia, along with fears of spike in Covid infections - ThePrint

New York City-based home-lab-test startup LetsGetChecked said this morning that it has wrapped up an oversubscribed $71 million Series C round co-led by Illumina Ventures and HLM Venture Partners.

The raise also included new backers Deerfield, CommonFund Capital and Angeles Investments, while investors Transformation Capital, Optum Ventures and Qiming Venture Partners USA returned to further fuel the startup's business. With this, Illumina's Nick Naclerio, founding partner, and HLM's Steven Tolle, partner, will be joining LetsGetChecked's board as members.

WHAT IT DOES

Founded in 2014, LetsGetChecked provides consumer customers with a range of at-home testing kits, such as ones for hormone levels, sexually transmitted infections, liver performance, nutritionand specifically for frontline healthcare workers COVID-19.

Customers receive their kit in the mail, with which they collect and return a personal sample for testing. One of the startup's lab partners analyzes the sample and returns it to a LetsGetChecked physician, who reviews the results and counsels customers over the phone, if necessary. For later reference, test results are saved in a LetsGetChecked patient app that interfaces with Apple Health, Fitbit, Garmin and other consumer-friendly health tools.

As of March, the company has also been offering a COVID-19 "twin-track" antibody and PCR test exclusive to providers working at the point of care. However, the company said it hopes to release a direct-to-consumer version of the testing kit down the road.

"The company's work has never been more important now that the world faces a global pandemic, forcing us all to re-evaluate how we obtain health and wellness services," Illumina's Naclerio said in a statement."LetsGetChecked is already having a profound impact on patient-led at-home healthcare, which is necessary now and will become increasingly common in the future."

WHAT IT'S FOR

The company said these funds will help build up its manufacturing, supply and testing capacity for COVID-19. It will be increasing activity at its California laboratorywhile boosting operations and partnerships across the U.S. and Europe.

"We have been developing our platform for more than five years and have helped hundreds of thousands of individuals by enabling access to high-quality testing and telehealth services in the home, across many health conditions," Peter Foley, CEO and founder of LetsGetChecked, said in a statement. "With the onset of COVID-19, we realigned resources with a view to helping with this global pandemic and are currently delivering tens of thousands of tests per day to critical and frontline healthcare workers"

MARKET SNAPSHOT

Consumer-facing home testing startups were already picking up momentum around the time of LetsGetChecked's $30 million Series B, with competitors like EverlyWell, healthy.io and Scanwell Health all announcing new rounds or services over the course of the last year. However, COVID-19 has ramped up demand across the industry and led to some confusion with the FDA on more than one occasion. But the window for these companies to take their COVID-19 tests directly to consumers appears to be reopening: It was just a few weeks ago that LabCorp's COVID-19 RT-PCR test became the first permitted for at-home sample collection.

ON THE RECORD

"HLM invests in companies that inherently drive adoption due to the need they serve, and companies that leverage important market trends," Tolle said in a statement. "In this case, LetsGetChecked is helping to improve consumer access to care, which is increasingly essential."

Original post:
LetsGetChecked locks in $71M Series C to expand COVID-19 testing capacity - MobiHealthNews

(MENAFN - GetNews)

Scottsdale, AZ - Getting medical help and attention does not have to be a stressful process. Essentially, a patient does not have to wait long hours to see a doctor for minor or major complaints and this is why the team at Desert Mobile Medical | Concierge Physicians has repackaged their medical services to offer patients the concierge and mobile medical attention that they deserve. At Desert Mobile Medical | Concierge Physicians, the doctors and primary healthcare providers come to patients wherever they may be, whether at home or work, to deliver the best quality of medical care services, all at an affordable price.

With the current global pandemic brought on by the novel coronavirus, Desert Mobile Medical | Concierge Physicians is working hard to ensure that the healthcare needs of its patients are met. This major concern has led to the announcement of offering the option for virtual appointments. With the capability to do virtual appointments, patients will be offered concierge services that are in line with the recommended social distancing and self-quarantine guidelines while still being able to dispense appropriate medications as necessary.

With Desert Mobile Medical | Concierge Physicians, patients can worry less about exposing themselves to more danger and health risks while waiting at the hospital or doctor's office for their appointments. The team of mobile medical doctors are always ready and on standby to attend to patients virtually or by visiting them in the comfort of their own home.

The concierge physicians at Desert Mobile Medical | Concierge Physicians are unique in the fact that they cut out the middle man (health insurance) so that they can spend more time with YOU, the patient. They have structured their model to be able to provide the highest quality of care while still saving their patients money, whether they have insurance or not. Over 70% of their patients have health insurance and have still found that Desert Mobile Medical provides better care at a lower cost.

Did you know that 90% of health issues can be solved with Direct Primary Care? Desert Mobile Medical | Concierge Physicians is Healthcare Built Around You' meaning they are convenient (since they go to your home), they are flexible (they typically accommodate for same day or next day appointments), and affordable (they take out the middleman, health insurance, to give you quality healthcare with no hidden costs or impossibly complicated invoices).

Overall one of the biggest benefits is saving on lost time. Not only the lost time of driving to the doctor's office and then waiting there for hours, but also because they give you the time needed so they can make sure you have the best care resulting in a more effective you.

Describing the personalized and unhurried care of a concierge doctor offered by the medical physicians at Desert Mobile Medical, a patient left a 5-star review for the online doctor saying, 'This is a fantastic service and I'm glad I found Dr Goel. He takes his time listening to your issue and explains what and why he is treating you the way he is. He doesn't have the typical just do as I say and all will be better' attitude. His focus on preventative care is unique, he prefers to prevent health problems from occurring rather than treat them after they happen. Being able to call, video chat or just message when you need him is the future of doctor appointments. He is quick to respond and does what he can to address your needs as quickly as he can.

Desert Mobile Medical | Concierge Physicians is currently accepting new patients, as they provide a full suite of the most important mobile doctor services to support your vibrant good health, even during this challenging time, by offering the option to visit your home or perform a virtual appointment.

The concierge physician will ensure that patients, during the pandemic, are well catered to. If a patient chooses to have a mobile doctor visit their home for their appointment, prior to their visit, the doctor will maintain COVID-19 safety procedures that will ensure the continued protection of patients from the global pandemic.

Desert Mobile Medical | Concierge Physicians offers services such as: hormone replacement therapy, mobile lab tests, vaccinations, in-home medical dispensing, mobile diagnostic imaging services, direct primary care services, as well as physical and massage therapy services.

Desert Mobile Medical | Concierge Physicians is headquartered at 9300 E Raintree Dr Suite 130 Suite 2, Scottsdale, AZ 85260. Contact their team via phone at (480) 427-0002 or send online inquiries via email to . For additional information regarding their services, visit their website.

Media Contact Company Name: Desert Mobile Medical Contact Person: Dr. Paresh Goel Email: Send Email Phone: (480) 427-0002 Address: 9300 E Raintree Dr Suite 130 Suite 2 City: Scottsdale State: AZ Country: United States Website: http://desertmobilemedical.com/

MENAFN0805202000703268ID1100137432

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Desert Mobile Medical | Concierge Physicians is Now Offering Virtual Appointments to Help Avoid the Spread of COVID-19 - MENAFN.COM

Working from home requires modifications to a traditional workday. The blending of responsibilities from two major areas of our lives, work and home, can be a considerable source of stress, especially during a pandemic.

This is a reality for me, and my husband is a clinical psychologist, so I asked him for some tips. Here is some advice from Dr. Eric W. Bravo on how to stay productive, reduce stress, and manage psychological well-being while working from home:

Cortisol, the main stress hormone in the brain and body, increases as aresult of stress. The blending of work and home obligations is certainly stressful. During a pandemic, everyones cortisol levels are elevated, even if they are not sick.

Chronic exposure to cortisol leads to fatigue, weight gain, sleep disturbance, and an overall negative mood. To reduce the brains exposure to heightened cortisol, several coping skills should be considered.

Maintaining a daily schedule is an important consideration in preventing depression, reducing stress, and increasing energy levels. In the morning, actively construct your day. Think of the tasks that you need to get accomplished.

Having an outline of your responsibilities will guide your actions through the day and leave you with a sense of accomplishment when you are ready to clockout. Think about how to use this time to your advantage. Ask yourself if it is possible to grow the business, make work more organized and efficient, or learn a new skill.

Be aware of limits your productivity and success caused by self-sabotaging. Vices are more accessible than ever. When working from home, it is easier to sleep in, nap during the day, and procrastinate. Hold yourself accountable to the same standard of discipline when you were going into the office.

Most importantly, wake up every day and dress for success. You may not need to wear a suit, but dress to be active. Be sure to wear proper shoes and leave the pajamas for sleeping only.

Changing clothesJanet Loehrke

The body and brain need routines from the most basic of sleeping and eating to other activities, such as work. We are programmed neurochemically to have basic daily cycles. When daily routines are disrupted, our neurological systems shift. Neurochemical imbalances can occur from a shift in daily cycles, leading to depression, anxiety, lethargy, and poor cognitive performance. The basics of a daily routine, including staying consistent with sleep/wake cycles, regular meals, exercise, and activity are essential.

Work-life boundaries are more important now than ever. Boundaries are the psychological barriers between our life at work and life at home. Create a separation between activities that are work-related and those that are not. As much as possible, have a dedicated workspace free from distractions, leisurely activities, and household responsibilities. The distance created by separating the space can let you focus on a productive workday and allow you to leave the office when needed.

To reduce packing on more stress, be careful to manage your expectations. It is common to be less productive when working from home. Develop a hierarchy of work tasks, target the most necessary first then work down your list. If you are unable to complete all of the work, be kind to yourself, take a break.

Think of coping skills as medication to treat an infirmity. We need to practice self-care to stay motivated, productive, and healthy. Immerse your mind and body in activities that are not related to being on duty. Meditation, exercise, cooking, reading, conversations with friends and support systems, and a good sweat all have an effect on lowering cortisol and increasing a positive mood. Furthermore, as important as it is to stay informed, limit your exposure to upsetting news.

Motivation and productivity take work, but, are attainable. The more that a person prepares for the day with a routine, the better off. Control the amount of time that you are not productive. It is fine to relax and watch a good movie, just have limits. Set boundaries for downtime. Getting in the habit of being sedentary will slow your mind, body, and energy. Conversely, consistent exercise and activity maintain and overall sense of motivation.

Hold yourself accountable by limiting the excuses to get work done. Chances are, these are the same rationalizations that are noticeable before working from home. Avoid working from your bed or bedroom. As comfortable as it may seem, a productive day requires being slightly uncomfortable. Our bedrooms have too many associations of relaxation. We do not want to contaminate the drive needed to complete our daily obligations. We also do not want to tarnish the mellow vibe of where we rest.

Engagement with online hangouts and meetings are crucial for perspective, social interaction, and coping with feelings of loneliness. Avoid isolation and make it a priority to reach out to your social network. Take it another step, change the dynamics, and reach out to a friend that you have not heard from in a while.

A new phenomenon, Zoom Fatigue, is leading to higher levels of lethargy and exhaustion during the workday. Video-conferencing requires much more focus and energy than in-person meetings. Paying attention to multiple people at once, figuring out eyecontact, and concerns about our digital appearance is draining. Interestingly, similar fatigue can also occur during social videoconferencing. In order to combat this fatigue, think about the necessity of using video. If a telephone call will suffice for work or social purposes, it is a much better option.

Practice the awareness of gratitude for your employment. Remind yourself of the reason that you do what you do. Think about your journey and accomplishments. Familiarize yourself with the mission of your job. In a time where unemployment rates are at an all-time high, you have employment to report to. Convince yourself that you have a purpose, arise, go forth, and conquer!

It can be difficult to work from home for long periods of time. By practicing these coping strategies, you can increase the likelihood of success, limit stress, and improve your mood. Keep in mind, we are not in control of what happens to us, but we are responsible for how we adapt and respond.

Editor's Note: The author and a source named in this article are married.

Read more here:
Working from home during the coronavirus pandemic: How to cope - USA TODAY

Deepak Chopra, Special to SFGate

By Deepak Chopra, MD, FACP, Rudolph E. Tanzi, PhD, Michelle Williams, ScD, Ryan Castle, William C. Bushell, PhD, Kimberly Brouwer, PhD, and Paul J. Mills, PhD

Although COVID-19 is very easily transmitted from person to person, the risk of subsequent hospitalization and death primarily affects people who are already at risk because of old age, infirmity and/or chronic diseases such as cancer, diabetes, autoimmune illness, obesity, and heart disease. All of these chronic illnesses are associated with measurable low-grade inflammation in the body. The chronic low-grade inflammation that develops with advanced age has become known as inflammaging. Most people with chronic illness unknowingly have low-grade inflammation. Recent research points to a second finding: these same disorders are often accompanied by persistent low-grade anxiety and depression.

All of this as a background increases the danger for a person when acute illness strikes. In addition to the elderly and chronically ill, COVID-19 is causing acute respiratory illness and stroke sometimes leading to death in seemingly otherwise healthy younger individuals. The transition from SARS-CoV-2 infection to diagnosed COVID-19 is typically accompanied by a cytokine storm. Cytokines are proteins that are major drivers of inflammation, and their rapid increase, or "storm is one of the bodys immune responses to acute threat.

In addition, studies have connected pro-inflammatory cytokines to the stress response; they regulate well-known stress hormones such as ACTH and cortisol. Three major systems are involved: the immune system, the central nervous system and the endocrine hormone system.

In the face of these connections, we are coming forward to suggest that complementary practicesdeep breathing, yoga, and meditationcan play an important role during this pandemic. These practices have been confirmed by hundreds of scientific studies to bring down over-activity of the autonomic nervous system, calm the mind from anxiety, reduce the stress response, regularize heartbeat, and lower blood pressure. Together, all of these diverse benefits are associated with reducing the invisible presence of chronic low-grade inflammation, especially if added to good sleep, exercise, and proper diet.

We dont fully understand how the immune response, linked to stress and inflammation, can turn lethal. As a response to cuts, wounds, invading pathogens, and other threats, prior to antibody formation, the body first responds with inflammation as a normal yet crucial healing function. But it has long been known that inflammation is paradoxical. Acute inflammation can over-react, harming or even killing the patient. (Instances of strokes and heart attacks among young COVID-19 patients might be linked to micro-cytokine storms in the brain and heart.)

The threat from low-grade chronic inflammation was not discovered until recently but seems to be widespread. It is unaccompanied by the swelling, burning, and redness of the skin that marks acute inflammation and therefore goes undetected by the patient or physician. Preventing and addressing chronic low-grade inflammation and its significant adverse consequences are urgent issues, even more urgent during a pandemic. There seems to be every reason to make the public aware how deep breathing, meditation, yoga, and other healthy lifestyle practices can help during this crisis and long afterwards.

Deepak Chopra MD, FACP, Clinical Professor of Family Medicine and Public Health at the University of California, San Diego

Rudolph E. Tanzi, PhD, Kennedy Professor of Neurology at Harvard Medical School/MGH

Michelle Williams, SM, ScD, Dean of the Faculty, Harvard T.H. Chan School of Public Health

Kimberly Brouwer, PhD, Professor and Chief, Department of Family Medicine and Public Health, Division of Global Health, Infectious Diseases Epidemiology, at the University of California, San Diego

Ryan Castle, Executive Director of the Chopra Library

William C. Bushell, PhD, medical anthropologist and research director of the Chopra Library

Paul J. Mills, PhD, Professor and Chief, Department of Family Medicine and Public Health, at the University of California, San Diego

Read more from the original source:
The Key to Handling Stress and COVID-19 - SFGate

CAMBRIDGE, Mass., May 5, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced positive top-line results from INNO2VATE, its global Phase 3 cardiovascular outcomes program evaluating the efficacy and safety of vadadustat, its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. (Please refer to Akebia's INNO2VATE Data Announcement for the top-line data.) The Company also reported financial results for the first quarter ended March 31, 2020 and will host a conference call with slides today, Tuesday, May 5, 2020, at 8:30 a.m. Eastern Time to discuss INNO2VATE top-line data, its first quarter financial results and recent business highlights.

"We are very excited about the positive top-line results from INNO2VATE and expect to build on this momentum with many potentially transformational near-term milestones," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "We believe we've developed an exciting path forward for vadadustat and although the COVID-19 environment remains unpredictable, we continue to execute and deliver solid progress against these initiatives. In collaboration with our partner, Mitsubishi Tanabe, we are advancing key pre-commercial activities in support of the first regulatory approval of vadadustat expected in Japan this year. We have also significantly advanced PRO2TECT, our global Phase 3 studies evaluating the safety and efficacy of vadadustat in adult patients not on dialysis with anemia due to CKD, and expect to report top-line data from these studies mid-year, as planned. In addition, we reinforced our intellectual property position for vadadustat, confirming the path for Akebia and our collaboration partner, Otsuka, to launch vadadustat in the U.K. and potentially the rest of Europe, upon approval."

"Akebia continues to provide and support our innovative therapies, which are critical to the care of adult patients with CKD, who are among the most at risk during this pandemic. To date, we have not experienced any significant adverse impact from COVID-19 and our fundamentals remain strong with a cash runway that extends well into 2021. However, these are unprecedented times and, due to COVID-19, we do not have clear visibility on how product demand and payer mix may be impacted. As a result, we continue to actively monitor and assess the potential impact of COVID-19 on our business and operations while continuing to support patients." Butler concluded, "We believe we have tremendous value-enhancing opportunities ahead and we remain focused on supporting patients and executing on our plans to position Akebia for long term growth."

Business Highlights

Today, the Company announced positive top-line results from INNO2VATE. Please refer to

for the top-line data.In April, the Patents Court of the United Kingdom issued a

in favor of Akebia and Otsuka Pharmaceutical Co. Ltd., which found that five of FibroGen, Inc.'s six HIF-related patents were invalid, and a sixth patent would not be infringed.In April, the Company announced that Myles Wolf, M.D., M.M.Sc., joined Akebia's Board of Directors. Dr. Wolf is a leading clinical nephrologist and physician-scientist in the fields of disordered mineral metabolism and cardiovascular disease in patients with CKD. Dr. Wolf serves as Chief of the Division of Nephrology and a Professor of Medicine at Duke University School of Medicine.In April, the Company settled Auryxia patent litigation with Teva Pharmaceuticals USA, Inc. (Teva) and its wholly owned, indirect subsidiary, Watson Laboratories, Inc. (Watson), resolving patent litigation brought in response to Abbreviated New Drug Application (ANDA) filings by Teva and Watson. Consistent with the Company's prior ANDA settlement with Par Pharmaceutical, Inc., the settlement allows Teva and Watson to market its generic version of Auryxia in the United States beginning on March 20, 2025 (subject to U.S. FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.In April, the Company entered into a new supply agreement with STA Pharmaceutical Hong Kong Limited, a subsidiary of Wuxi AppTec (WuXi), under which WuXi will manufacture vadadustat drug substance for commercial use. The WuXi supply agreement is the third commercial supply agreement the Company has entered into for vadadustat. The Company entered into a commercial supply agreement for vadadustat drug substance with Esteve Qumica, S.A. in April 2019, and a commercial supply agreement for vadadustat drug product with Patheon Inc. in March 2020.In April, the United States District Court for the District of Delaware dismissed a putative securities class action brought against the Company's wholly owned subsidiary, Keryx Biopharmaceuticals, Inc. (Keryx), and former members of Keryx's board of directors, relating to the Company's 2018 merger with Keryx in response to a motion to dismiss filed by Keryx and the former directors.In February, the Company entered into a letter agreement with Vifor (International) Ltd. (Vifor Pharma) relating to Vifor Pharma's agreement with a third party to purchase a Priority Review Voucher (PRV) issued by the U.S. Food and Drug Administration (FDA), subject to satisfaction of customary closing conditions. Pursuant to the letter agreement, Akebia paid Vifor Pharma $10 million. Vifor Pharma is obligated to reserve the PRV for the vadadustat NDA for the treatment of anemia due to CKD in dialysis-dependent and non-dialysis dependent patients until Akebia and Vifor Pharma agree on the financial and other terms under which it will assign the PRV to Akebia or make a mutual decision to sell the PRV. A PRV entitles the holder to priority review of an NDA or a Biologics License Application for a new drug, which reduces the target FDA review time to six months after official acceptance of the submission and could lead to expedited approval.

First Quarter Financial Results

Revenues: Total revenue increased 22 percent to $88.5 million for the first quarter of 2020 compared to $72.7 million for the first quarter of 2019.Collaboration revenue was $59.3 million for the first quarter of 2020 compared to $49.6 million in the first quarter of 2019, an increase of 20 percent.Net product revenue was $29.2 million for the first quarter of 2020 compared with $23.1 million in the first quarter of 2019, an increase of 26 percent.COGS: Cost of goods sold was $27.7 million for the first quarter of 2020, which includes non-cash charges, related to the application of purchase accounting as a result of the merger with Keryx, of $11.2 million for inventory step-up and $9.1 million for amortization of intangibles. Cost of goods sold was $31.3 million for the first quarter of 2019, and included non-cash merger-related charges of $14.6 million for inventory step-up and $9.1 million for amortization of intangibles.R&D Expenses: Research and development expenses were $81.2 million for the first quarter of 2020 compared to $82.4 million for the first quarter of 2019.SG&A Expenses: Selling, general and administrative expenses were $38.0 million for the first quarter of 2020 compared to $34.3 million for the first quarter of 2019.Net Loss: Net loss was $60.7 million for the first quarter of 2020 compared to $72.4 million for the first quarter of 2019.Cash Position: Cash, cash equivalents and available-for-sale securities as of March 31, 2020 were $115.4 million. The Company's cash runway extends well into 2021. The Company's cash runway, consistent with previous commentary, includes the receipt of a $15.0 million regulatory milestone from Mitsubishi Tanabe Pharma Corporation, Akebia's development and commercialization collaboration partner in Japan for vadadustat, assuming approval of vadadustat in Japan.

"Consistent with our prior first quarter periods, the decrease in the Company's cash, cash equivalents and available-for-sale securities from year-end 2019 was due to the timing of cash payments from our collaboration partner, Otsuka, for which $49.5 million was received in the current quarter rather than the first quarter of 2020. In addition, during the first quarter, we paid $10 million to Vifor Pharma in connection with Vifor Pharma's purchase of the PRV," stated Jason A. Amello, Chief Financial Officer of Akebia.

COVID-19 Response The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19), pandemic has presented a substantial public health and economic challenge around the world and is affecting Akebia's employees, patients, customers, collaboration partners, vendors, communities and business operations. On March 15, 2020, Akebia issued a press release detailing its response to the COVID-19 pandemic. Consistent with that statement, the Company continues to take action to safeguard its employees, patients and customers, ensure business continuity, and support supply of its innovative therapies which are critical to the care of adult CKD patients, who are among the most at risk during this pandemic. Akebia continues to actively monitor and assess the potential impact of the COVID-19 pandemic on its business and operations. Patients with any questions about accessing Akebia's marketed therapy may refer to AkebiaCares, the Company's patient access program, for further information.

Conference Call: Akebia will host a conference call today, Tuesday, May 5, 2020, at 8:30 a.m. Eastern Time to discuss its INNO2VATE top-line data announced earlier this morning and its first quarter financial results. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 8464788. The call will also be webcast LIVE with slides and can be accessed via the Investors section of the Company's website at http://ir.akebia.com.

A replay of the conference call and the slides will be available two hours after the completion of the call through May 11, 2020. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 8464788. An online archive of the conference call can be accessed via the Investors section of the Company's website at http://ir.akebia.com.

About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at http://www.akebia.com which does not form a part of this release.

About Vadadustat Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

About Anemia due to Chronic Kidney Disease (CKD) Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person's quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.

Forward-Looking Statements Statements in this press release regarding Akebia's strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding clinical trial data and results and the anticipated timing of the availability and reporting thereof; Akebia's momentum and potentially transformational near-term milestones; the safety and efficacy of vadadustat, the potential launch of vadadustat, the potential indications for and benefits of vadadustat, and market size, commercial potential, prevalence, and the growth in, and potential demand for, vadadustat; access to a Priority Review Voucher for vadadustat and the agreement relating thereto; potential and anticipated payments from our collaborators, including the timing thereof; expectations regarding financial position, including cash runway and the components thereof; and our intellectual property position. The terms "anticipate," "believe," "expect," "opportunity," "planned," "potential," "target," "will" and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the potential direct or indirect impact of the COVID-19 pandemic on our business, operations, and the markets and communities in which we and our partners, collaborators, vendors and customers operate; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials, including PRO2TECT; the risk that clinical trials may not be successful; manufacturing risks; risks associated with the Priority Review Voucher for vadadustat; risks associated with management and key personnel changes and transitional periods; the actual funding required to develop and commercialize our commercial product, vadadustat and other product candidates and operate the Company, and the actual expenses associated therewith; the actual costs incurred in the clinical studies of vadadustat and the availability of financing to cover such costs; the risk that clinical studies are discontinued or delayed for any reason, including for safety, tolerability, enrollment, manufacturing or economic reasons; market acceptance and coverage and reimbursement of our commercial product and vadadustat, if approved; the risks associated with potential generic entrants for our commercial product and vadadustat, if approved; early termination of any of Akebia's collaborations; Akebia's and its collaborators' ability to satisfy their obligations under Akebia's collaboration agreements; the timing and content of decisions made by regulatory authorities; the timing of any additional studies initiated for vadadustat; the actual time it takes to initiate and complete preclinical and clinical studies; the competitive landscape for our commercial product and vadadustat; the scope, timing, and outcome of any legal, regulatory and administrative proceedings; changes in the economic and financial conditions of the businesses of Akebia and its partners; the risk that we lose, or settle on less favorable terms, other ANDA litigation, or that other ANDA filers enter the market earlier than March 20, 2025, as well as any other potential settlements; and Akebia's ability to obtain, maintain and enforce patent and other intellectual property protection for our commercial product, vadadustat and any other product candidates. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-K for the year ended December 31, 2019 and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Investor Contact: Kristen K. Sheppard, Esq. Ir@akebia.com

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Akebia Announced Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult...

In the early 1950s, psychiatrists began treating schizophrenia with a new drug called chlorpromazine. Seven decades later, the drug is still used as an anti-psychotic.

But now scientists have discovered that the drug, also known as Thorazine, can do something entirely different. It can stop the new coronavirus that causes Covid-19 from invading cells.

Driven by the pandemics spread, research teams have been screening thousands of drugs to see if they have this unexpected potential to fight the coronavirus. Theyve tested the drugs on dishes of cells, and a few dozen candidates have made the first cut.

Theyre startlingly diverse. Some, like chlorpromazine, have been used for years not for viral infections, but for conditions including cancer, allergies, arthritis, even irregular menstrual periods. Other drugs have not yet been approved by the Food and Drug Administration, but they have already proven safe in clinical trials. Their track records might help them get approved faster than a drug designed from scratch.

As researchers publish findings on these promising drugs, theyre starting tests on animals and people to see how well they perform. No one should try self-medicating with any of the drugs for Covid-19, the researchers warned, since they may have dangerous side effects and have yet to be proven effective in clinical trials.

Im going to be brutally honest with you: 95 to 98 percent of these are going to fail, said Sumit K. Chanda, a virologist at Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Calif. But we only need one or two.

The strategy Dr. Chanda and other researchers are using is known as drug repurposing. It has a history that started decades before Covid-19 appeared. In 1987, for example, the cancer drug zidovudine became the first F.D.A.-approved drug against H.I.V.

The most obvious drugs to repurpose against the new coronavirus are those that work against other viruses. One high-profile antiviral being investigated is remdesivir, which Gilead Sciences previously tested unsuccessfully as an antiviral against Ebola.

But over the years, researchers have found some drugs that originally had nothing to do with viruses turn out to be good antivirals, too. Its just hard to tell in advance which ones have this hidden power.

We dont know a lot about why drugs do what they do, said Matthew Frieman, a virologist at the University of Maryland School of Medicine.

In 2012, another coronavirus disease known as MERS emerged in the Middle East. Dr. Frieman responded by starting a drug-repurposing study. He and his colleagues tested 290 F.D.A.-approved drugs and found that 27 of them blocked the MERS virus from infecting cells. They also proved effective against the related coronavirus that causes SARS.

Dr. Frieman and his colleagues have now tested those drugs against the new coronavirus, and made a preliminary report that 17 of them showed promise. Along with chlorpromazine, they include drugs for disorders as varied as Parkinsons disease and leukemia.

Recently, Dr. Chandas team in California began a mammoth search of their own for drugs to repurpose for Covid-19. They doused infected cells with 13,000 compounds and looked for ones that slowed down the virus. They then narrowed down these candidates by reducing their doses, in order to mimic the levels that would end up in a patients lungs.

On April 17, Dr. Chandas team reported in a preprint, which has not yet been peer-reviewed by a journal, that six drugs showed particular promise, including one for osteoporosis and one thats been investigated as treatment for arthritis.

Yet another team has been trying to find drugs that work against coronavirus and also to learn why they work.

The team, led by Nevan Krogan at the University of California, San Francisco, has focused on how the new coronavirus takes over our cells at the molecular level.

The researchers determined that the virus manipulates our cells by locking onto at least 332 of our own proteins. By manipulating those proteins, the virus gets our cells to make new viruses.

Dr. Krogans team found 69 drugs that target the same proteins in our cells the virus does. They published the list in a preprint last month, suggesting that some might prove effective against Covid-19.

The researchers shipped the compounds to the Icahn School of Medicine at Mount Sinai in New York and at the Pasteur Institute in Paris. Those labs tried them out on infected cells.

Brian Shoichet, a pharmaceutical chemist at U.C.S.F. who helped build the list, was keenly aware of how often drug repurposing fails.

I wasnt that hopeful at all, he said.

It turned out that most of the 69 candidates did fail. But both in Paris and New York, the researchers found that nine drugs drove the virus down.

The things were finding are 10 to a hundred times more potent than remdesivir, Dr. Krogan said. He and his colleagues published their findings Thursday in the journal Nature.

Strikingly, the drugs hit only two targets.

One group temporarily stops the creation of new proteins inside cells. This group includes molecules that are being tested as cancer drugs, such as ternatin-4 and Zotatifin.

Dr. Shoichet speculated that these compounds starve the virus of the proteins it needs to make new copies of itself. This attack may suddenly halt the viral production line.

Viruses are actually delicate beasts, he said.

The other compounds home in on a pair of proteins known as Sigma-1 and Sigma-2 receptors. These receptors are part of the cells communication network, helping the cell withstand stress in its environment.

Why does the new coronavirus need to manipulate Sigma receptors? We dont really know, Dr. Shoichet said.

One possibility is that the virus uses Sigma receptors to make a cell produce more of the oily molecules that form membranes for new viruses.

Among the substances that act on Sigma receptors and block the virus, the researchers found, are the hormone progesterone and the drugs clemastine and cloperastine, both used against allergies.

In addition, Dr. Krogan said that all of Dr. Friemans candidates, including chlorpromazine, target Sigma receptors. A third of Dr. Chandas candidates do too, he said.

The researchers also tested dextromethorphan, a Sigma-receptor-targeting drug in many brands of cough syrup. They were surprised to find that, at least in their cell samples, it actually made infections of this coronavirus worse.

In their paper, the researchers raised the possibility that Covid-19 patients may want to avoid dextromethorphan. Dr. Krogan emphasized that more study would be needed to see if it actually increases coronavirus infection in humans. But if it was me, he said, to be cautious, I would not be taking these cough syrups.

The anti-malaria drugs chloroquine and hydroxychloroquine act on the Sigma receptor. Dr. Krogans team found that they also fought the virus in cells. Those compounds were extolled by President Trump for weeks despite no firm evidence they actually helped cure Covid-19.

Dr. Frieman and Dr. Chanda also found that chloroquine-related drugs worked fairly well in slowing the virus in cell cultures. But Dr. Chanda found they didnt work as well as the six compounds at the top of his list.

Dr. Chanda expressed skepticism about the chloroquine drugs, noting their failure against other viruses.

Weve been down this road multiple times, he said. I would happy to be wrong about this.

Last week, the F.D.A. issued a warning against using hydroxychloroquine or chloroquine for Covid-19 outside the hospital setting or a clinical trial. Thats because the drug has a well-known risk for causing irregular heart rhythms.

In their new study, Dr. Krogan and his colleagues ran an experiment that might explain this risk at the molecular level.

They found that chloroquine and hydroxychloroquine bind not just to Sigma receptors, but to a heart protein called hERG, which helps control heartbeats.

I think its a rational argument, said Dr. Frieman, who was not involved in the Nature study. Chloroquine does a lot of things in the cell.

Dr. Krogan and his colleagues found that other compounds target Sigma proteins in a more promising way.

An experimental anticancer compound called PB28 is 20 times more potent than hydroxychloroquine against the coronavirus, for example. But its far less likely to grab onto the hERG protein.

Dr. Chanda said that PB28 in particular looks really fantastic.

Dr. Krogan said that studies are underway to test the drug in hamsters to see if that promise holds. Dr. Frieman and his colleagues are starting animal studies of their own, as well as testing drugs on a chip lined with human lung cells.

Timothy Sheahan, a virologist at the University of North Carolina who was not involved in the new studies cautioned that it will take more testing to make sure these promising drugs are safe to give to patients ravaged by Covid-19.

Cancer drugs, for example, can be like a sledgehammer to your body, he noted. Are you going to want to do that when someone is really sick?

In addition to animal tests and clinical trials, researchers are now planning to tweak the structure of these drugs to see if they can work even more effectively against the virus.

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Old Drugs May Find a New Purpose: Fighting the Coronavirus - The New York Times

WEDNESDAY, April 29, 2020 (HealthDay News) -- New research adds to a growing body of evidence that suggests men are far more vulnerable to severe COVID-19 than women are.

Although both genders fall ill in the same numbers, men are 2.5 times more likely to get severe disease and die, the study from China showed.

The finding comes as scientists in New York and California are starting to test a novel hypothesis that sex hormones might play a part in disease severity.

Last week, doctors on Long Island started treating COVID-19 patients with estrogen to boost their immune systems, The New York Times reported. And beginning next week, physicians in Los Angeles will start treating male patients with progesterone, a hormone that is predominantly found in women. Progesterone has anti-inflammatory properties and might prevent the immune system from overreacting, the researchers explained.

"There's a striking difference between the number of men and women in the intensive care unit, and men are clearly doing worse," Dr. Sara Ghandehari, a pulmonologist and intensive care physician at Cedars-Sinai in Los Angeles, told the Times. She is the principal investigator for the progesterone study.

But experts who study sex differences in immunity warned that hormones may not be the answer. Even elderly women with COVID-19 are outliving their male peers, despite drastic reductions in levels of hormones for women after menopause, they noted.

In the study from China, published April 29 in the journal Frontiers in Public Health, the differences between men and women showed up early in the coronavirus pandemic.

"Early in January, we noticed that the number of men dying from COVID-19 appeared to be higher than the number of women," explained researcher Dr. Jin-Kui Yang, a physician at Beijing Tongren Hospital.

"This raised a question: Are men more susceptible to getting or dying from COVID-19? We found that no one had measured gender differences in COVID-19 patients, and so began investigating," Yang said in a journal news release.

Included in the study were 43 patients treated by Yang's team, plus data on an additional 1,000 COVID-19 patients. The researchers also looked at the records of 524 SARS patients from 2003.

According to one large COVID-19 dataset, more than 70% of the patients who died were male, which meant that men had 2.5 times the death rate of women.

Being a man was also a risk factor for more severe illness, regardless of age.

Men who had SARS were also more likely to die, compared with women, Yang's team noted. Also, men had higher levels of the ACE2 protein involved in both sicknesses, which may be an explanation.

Although more research is needed, Yang recommended that "additional supportive care and prompt access to the intensive care unit may be necessary for older male patients."

More information

For more on COVID-19, see the U.S. Centers for Disease Control and Prevention.

SOURCES: Frontiers in Public Health, news release, April 29, 2020; The New York Times

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COVID-19 Continues to Strike Men Harder Than Women - HealthDay

As the novel coronavirus swept through communities around the world, preying disproportionately on the poor and the vulnerable, one disadvantaged group has demonstrated a remarkable resistance. Women, whether from China, Italy or the U.S., have been less likely to become acutely ill and far more likely to survive.

Which has made doctors wonder: Could hormones produced in greater quantities by women be at work?

Now scientists on two coasts, acting quickly on their hunches in an effort to save mens lives, are testing the hypothesis. The two clinical trials will each dose men with the sex hormones for limited durations.

Last week, doctors on Long Island in New York started treating Covid-19 patients with estrogen in an effort to increase their immune systems, and next week, physicians in Los Angeles will start treating male patients with another hormone that is predominantly found in women, progesterone, which has anti-inflammatory properties and can potentially prevent harmful overreactions of the immune system.

Theres a striking difference between the number of men and women in the intensive care unit, and men are clearly doing worse, said Dr. Sara Ghandehari, a pulmonologist and intensive care physician at Cedars-Sinai in Los Angeles who is the principal investigator for the progesterone study. She said 75 percent of the hospitals intensive care patients and those on ventilators are men.

And pregnant women, who are usually immunocompromised but have high levels of estrogen and progesterone, tend to have mild courses of the disease. So something about being a woman is protective, and something about pregnancy is protective, and that makes us think about hormones, Dr. Ghandehari said.

Some experts who study sex differences in immunity, however, warned that hormones may fail to be the magic bullet that some are hoping for; even elderly women with Covid-19 are outliving their male peers, and there is a drastic reduction in levels of hormones for women after menopause.

The genesis of the estrogen trial at the Renaissance School of Medicine at Stony Brook University on Long Island stemmed from a similar observation, said Dr. Sharon Nachman, the trials principal investigator, who credited a Stony Brook surgeon, Dr. Antonios Gasparis, with the idea.

The trial enrolled its first patient this past week, and preliminary results could be available in a few months, she said.

Its totally out of the box, which is how good ideas often start, said Dr. Nachman, associate dean for research at the Renaissance School, which is part of the State University of New York.

The gender gap in coronavirus survival became apparent early in the pandemic. Reports from China indicated men were dying at higher rates, but the disparity was attributed to higher smoking rates. But the outcomes were consistent in other countries, with men in Italy dying at higher rates than women, and men in New York City dying at nearly double the rate of women.

Scientists who study sex differences say that both biological differences in immunity, as well as behavioral factors are at play. Men smoke more almost everywhere, they say; men also wash their hands less. While women appear to have more robust immune systems, these experts say, the causes are complex and multifactorial, and hormones are only part of the picture.

If such sex hormones were the primary protective factor for women, then elderly women with Covid-19 would fare as poorly as elderly men, because womens reproductive hormones plummet after menopause, said Sabra Klein, a scientist who studies sex differences in viral infections and vaccination responses at the Johns Hopkins Bloomberg School of Public Health.

But thats not the case, she said.

We see this bias across the life course, Dr. Klein said. Older men are still disproportionately affected, and that suggests to me its got to be something genetic, or something else, thats not just hormonal.

Estrogen has immune modulatory properties dont get me wrong, she continued. You could get a beneficial effect in both men and women. But if women are better at recovery at 93 years old, I doubt its hormones.

Research has shown estrogen may have an effect on a protein known as angiotensin-converting enzyme 2 (ACE2), for example. The coronavirus uses ACE2 receptors on the surfaces of cells as an entry route, and ACE2 is regulated differently in men and women, said Kathryn Sandberg, director of the Center for the Study of Sex Differences in Health, Aging and Disease at Georgetown University.

In studies with rats, Dr. Sandberg and her colleagues have shown that estrogen can reduce ACE2 protein expression in their kidneys, so it is possible the hormone may reduce ACE2 expression in men as well.

Dr. Nachman said, We may not understand exactly how estrogen works, but maybe we can see how the patient does, adding that estrogen plays a complex role, both in the early immune response that can help clear a viral infection, as well as in a secondary clean up or repair response, which can evolve into a cytokine storm.

While we see women do get infected, their responses are different, Dr. Nachman said. We see fewer of them having the second, disregulated immune response.

The Stony Brook estrogen trial is recruiting 110 patients who come to the hospitals emergency room with symptoms like fever, cough, shortness of breath or pneumonia, and who have either tested positive for Covid-19 or are presumed to have the illness, as long as they do not require intubation.

The trial is open to adult men as well as to women aged 55 and older, since they have low levels of estrogen. Half of the participants will be given an estradiol patch for one week, while the other half will serve as a control group, and researchers will follow them to see whether estrogen reduces the severity of their disease.

The Cedars-Sinai study is smaller, with only 40 subjects, all men, half of whom will be a control group. Only hospital inpatients with mild to moderate disease who have tested positive for Covid-19 can participate. (Patients with certain conditions, like a history of blood clots, are excluded for safety reasons.)

The patients will get two shots of progesterone a day for five days.

They will be monitored to see if their status is improving, how their needs for oxygen change and whether they go on to require intensive care or mechanical ventilation; their progress will be compared to patients in the control group.

The researchers in Los Angeles are pinning their hopes on progesterone rather than estrogen because research has shown that the hormone reduces pro-inflammatory immune cells, and supports those that fight inflammation, Dr. Ghandehari said. The hypothesis is that progesterone will prevent or dampen a harmful overreaction of the immune system, called a cytokine storm, and will reduce the likelihood of acute respiratory distress syndrome.

Both hormones are believed to be safe, especially when used for short durations. Participants will be warned of possible side effects that may be a first for many men, like tenderness in the breast and hot flashes.

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Can Estrogen and Other Sex Hormones Help Men Survive Covid-19? - The New York Times

Provided by SF Gate

By Deepak Chopra, MD, FACP, Rudolph E. Tanzi, PhD, Michelle Williams, ScD, Ryan Castle, William C. Bushell, PhD, Kimberly Brouwer, PhD, and Paul J. Mills, PhD

Although COVID-19 is very easily transmitted from person to person, the risk of subsequent hospitalization and death primarily affects people who are already at risk because of old age, infirmity and/or chronic diseases such as cancer, diabetes, autoimmune illness, obesity, and heart disease. All of these chronic illnesses are associated with measurable low-grade inflammation in the body. The chronic low-grade inflammation that develops with advanced age has become known as inflammaging. Most people with chronic illness unknowingly have low-grade inflammation. Recent research points to a second finding: these same disorders are often accompanied by persistent low-grade anxiety and depression.

All of this as a background increases the danger for a person when acute illness strikes. In addition to the elderly and chronically ill, COVID-19 is causing acute respiratory illness and stroke sometimes leading to death in seemingly otherwise healthy younger individuals. The transition from SARS-CoV-2 infection to diagnosed COVID-19 is typically accompanied by a cytokine storm. Cytokines are proteins that are major drivers of inflammation, and their rapid increase, or "storm is one of the bodys immune responses to acute threat.

In addition, studies have connected pro-inflammatory cytokines to the stress response; they regulate well-known stress hormones such as ACTH and cortisol. Three major systems are involved: the immune system, the central nervous system and the endocrine hormone system.

In the face of these connections, we are coming forward to suggest that complementary practicesdeep breathing, yoga, and meditationcan play an important role during this pandemic. These practices have been confirmed by hundreds of scientific studies to bring down over-activity of the autonomic nervous system, calm the mind from anxiety, reduce the stress response, regularize heartbeat, and lower blood pressure. Together, all of these diverse benefits are associated with reducing the invisible presence of chronic low-grade inflammation, especially if added to good sleep, exercise, and proper diet.

We dont fully understand how the immune response, linked to stress and inflammation, can turn lethal. As a response to cuts, wounds, invading pathogens, and other threats, prior to antibody formation, the body first responds with inflammation as a normal yet crucial healing function. But it has long been known that inflammation is paradoxical. Acute inflammation can over-react, harming or even killing the patient. (Instances of strokes and heart attacks among young COVID-19 patients might be linked to micro-cytokine storms in the brain and heart.)

The threat from low-grade chronic inflammation was not discovered until recently but seems to be widespread. It is unaccompanied by the swelling, burning, and redness of the skin that marks acute inflammation and therefore goes undetected by the patient or physician. Preventing and addressing chronic low-grade inflammation and its significant adverse consequences are urgent issues, even more urgent during a pandemic. There seems to be every reason to make the public aware how deep breathing, meditation, yoga, and other healthy lifestyle practices can help during this crisis and long afterwards.

Deepak Chopra MD, FACP, Clinical Professor of Family Medicine and Public Health at the University of California, San Diego

Rudolph E. Tanzi, PhD, Kennedy Professor of Neurology at Harvard Medical School/MGH

Michelle Williams, SM, ScD, Dean of the Faculty, Harvard T.H. Chan School of Public Health

Kimberly Brouwer, PhD, Professor and Chief, Department of Family Medicine and Public Health, Division of Global Health, Infectious Diseases Epidemiology, at the University of California, San Diego

Ryan Castle, Executive Director of the Chopra Library

William C. Bushell, PhD, medical anthropologist and research director of the Chopra Library

Paul J. Mills, PhD, Professor and Chief, Department of Family Medicine and Public Health, at the University of California, San Diego

Read the original:
The Key to Handling Stress and COVID-19 - msnNOW

Campus News

The Chancellor Charles P. Norton Medal is UB's highest honor. Photo: Douglas Levere

UBNOW STAFF

Mary Wilson, wife of the late Buffalo Bills owner Ralph Wilson and a strong advocate of Western New York for the past 29 years, will be awarded the Chancellor Charles P. Norton Medal, UBs highest honor.

Jean Wactawski-Wende, SUNY Distinguished Professor of Epidemiology, dean of the School of Public Health and Health Professionals, and an internationally recognized researcher on womens health issues, will receive the UB Presidents Medal in recognition of extraordinary service to the university.

SUNY honorary doctorates are being presented to UB alumna Donnica L. Moore, president of the Sapphire Womens Health Group, and Richard A. Schatz, research director of cardiovascular interventions at the Scripps Heart, Lung and Vascular Center.

Wactawski-Wende will receive the Presidents Medal during the School of Public Health and Health Professions virtual commencement ceremony on May 16; the other award recipients will receive their honors at a later date.

The Chancellor Charles P. Norton Medal is presented annually in public recognition of a person who has, in Nortons words, performed some great thing which is identified with Buffalo a great civic or political act, a great book, a great work of art, a great scientific achievement or any other thing which, in itself, is truly great and ennobling, and which dignifies the performer and Buffalo in the eyes of the world.

Announcing this years Norton Medal recipient, Jeremy M. Jacobs, chair of the UB Council, said that Mary Wilson richly deserves the honor for her longstanding commitment to the region.

This year, we were absolutely unanimous in our decision to honor Mary Wilson, he said. In her leadership of the Wilson Foundation, Mary is making an enduring and unprecedented impact on Buffalo and all of Western New York, which will be felt for many generations to come. Her dedication and work align perfectly with the spirit of the Norton Medal.

Wilson has been devoted to Western New York since she first arrived in the area for the Bills home opener in 1990. She has spent many years developing her Western New York Girls in Sports program, which biannually brings more than 200 9- to 12-year-old girls together to take part in various sports taught by young athletes from local universities and sports clubs. The program, now ensured to run in perpetuity, is organized by the United Way of Buffalo and Erie County through an endowment from the Ralph C. Wilson Jr. Foundation, of which Wilson serves as one of four life trustees.

She has also supported organizations benefiting communities in Buffalo, Erie County and Southeast Michigan, among them Hospice of Western New York, WNY Womens Foundation, Food Bank of Western New York, Albright-Knox Art Gallery, Girl Scouts of Western New York, the SPCA serving Erie County, the Buffalo Philharmonic Orchestra, the Alzheimers Association Greater Michigan Chapter, The Helm (formerly Services for Older Citizens), the Detroit Symphony Orchestra, the Detroit Historical Society and the Detroit Institute of Arts, to name a few.

The UB Presidents Medal, first presented in 1990, recognizes outstanding scholarly or artistic achievements, humanitarian acts, contributions of time or treasure, exemplary leadership or any other major contribution to the development of the University at Buffalo and the quality of life in the UB community.

President Satish K. Tripathi described recipient Jean Wactawski-Wende as a world-renowned epidemiologist who has brought great prominence to UB through her scholarly pursuits and academic excellence in the area of womens health.

A dedicated member of our university community for more than 30 years, Dr. Wactawski-Wende has made seminal contributions that have significantly impacted health care practice and disease prevention for women in the U.S. and around the world, he said.

Thanks to her tremendous leadership, she has further elevated the reputation of UB. Our university community, along with the many communities we serve, have been profoundly enriched by Dr. Wactawski-Wendes scholarship, teaching and service, and it is an honor to present the Presidents Medal to such a truly deserving recipient.

Of particular note is Wactawski-Wendes leadership role in the Womens Health Initiative (WHI), the largest longitudinal study of womens health in the United States. In 1993, she was part of the team that spearheaded UBs successful bid to become one of the federally funded studys 16 original vanguard clinical centers. Since the inception of the WHI, UB has received more than $30 million in funding from the National Institutes of Health to investigate health issues impacting postmenopausal women.

Among the WHIs major discoveries was the groundbreaking finding that intake of combined estrogen plus progestin was associated with an increased risk of heart disease, stroke and invasive breast cancer. That research, on which Wactawski-Wende served as a co-principal investigator, changed the use of hormone therapy in older women worldwide, potentially saving countless lives.

Through UBs current $6.2 million award extension of the WHI, she has overseen the continuation of research into many diseases associated with aging, such as cardiovascular disease, cancer, osteoporosis, stroke and dementia. She is also administering new studies that focus on frailty and predictors of healthy aging.

For those of us who know and have worked closely with Dr. Wactawski-Wende, we readily recognize the magnitude and excellence of her contributions to academic medicine, said Michael E. Cain, vice president for health sciences and dean of the Jacobs School of Medicine and Biomedical Sciences at UB. She is an eminent and distinguished scholar and leader whose work, professional service, and stature in her discipline and research field are outstanding and continue to grow.

An internationally recognized womens health expert and advocate, Donnica L. Moore is president of Sapphire Womens Health Group, a multimedia firm that educates women about the benefits of a healthy lifestyle. A pioneering physician, Moore utilizes public speaking and multiple media platforms including her own website and podcast to share impactful health information in laypersons terms.

She will receive a SUNY Honorary Doctorate in Science.

Dr. Moores significant accomplishments associated with women's health set an inspiring example for our university community and reflect the values of both UB and the SUNY system, Tripathi said.

Breaking barriers to educate women about an array of health-related topics, she has demonstrated a sustained and dedicated commitment to the well-being of women around the globe. One of UBs most distinguished alumni, Dr. Moore in utilizing accessible platforms to create broad access to sound, peer-reviewed medical information is enhancing lives in communities near and far.

A 1986 alumna of the Jacobs School of Medicine and Biomedical Sciences, Moore underwent residency training in obstetrics and gynecology at Temple University, followed by a year of family medicine training at Memorial Hospital of Burlington, New Jersey. The editor-in-chief of Womens Health for Life, she has served on the editorial boards of the Journal of Women's Health and the Journal of the American Medical Womens Association, in addition to the board of directors of the Society for Womens Health Research, among other organizations.

Known for her relatable delivery and depth of expertise, Moore was the womens health contributor for NBCs Later Today and has appeared more than 800 times on such programs as The Oprah Winfrey Show, The Anderson Cooper Show and Good Morning America. Additionally, she has been a medical adviser or medical advisory board member for companies including DuPont and Helm Pharmaceuticals.

Richard A. Schatz is co-creator of the first coronary stent approved by the Food and Drug Administration for restenosis. Known as the Palmaz-Schatz stent, this life-saving device has been used to treat coronary artery disease in nearly 100 million patients worldwide since its approval in 1994. It is considered one of the top 10 medical device patents of the past 50 years.

He will receive a SUNY Honorary Doctorate in Science.

Dr. Schatz is widely known as the father of modern interventional cardiology for good reason, Tripathi said. Every day, his groundbreaking work is realized in operating rooms across the country and beyond. The stent he co-created spurred a revolution in the treatment of coronary artery disease and, 30 years later, it has had an immeasurable impact on health care.

By contributing to society through his biomedical innovations and inventions, Dr. Schatz has improved the lives of tens of millions of people while embodying the ideals of our university community and our university system.

A New York native, Schatz is the research director of cardiovascular interventions at the Scripps Clinic and director of gene and stem cell therapy. He is an elected fellow of the American College of Cardiology; in 2019, he received the Fritz J. And Dolores H. Russ Prize, which recognizes biomedical engineering achievements that have significantly improved the human condition. He is also the recipient of the Barton Haynes Lifetime Scholar Award from Duke University Medical Center.

Schatz attended UB in the early 1970s before gaining early admission to Duke Medical School, then completed his cardiology training at Brooke Army Medical Center. Throughout his career, he has maintained a strong affinity for UB, crediting the universitys faculty and curriculum for inspiring him to pursue a career in medicine.

Read more:
Wilson to receive Norton Medal - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter

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May 1, 2020

Find out more about the coronavirus pandemic.

By Dr. Jenifer Maynard

WHAT IS CORONAVIRUS and WHAT IS A PANDEMIC?

COVID-19 PRIMARILY SPREADS FROM PERSON TO PERSON AND FROM CONTAMINATED OBJECTS AND SURFACES

SYMPTOM RECOGNITION

DIAGNOSIS

TREATMENT

REDUCE YOUR RISK OF COVID-19! FOLLOW THESE GUIDELINES

THE IMMUNE SYSTEM

The immune system is complex, is composed of special organs, cells, and chemicals that prevent, limit and fight infection. The main components of the immune system include white blood cells, antibodies, the complement system, the lymphatic system, the spleen, the thymus, and bone marrow. Keep your immune system fighting fit with a comprehensive approach to all aspects of your health: physical, mental, emotional, and spiritual.

1. Dont smokea. Smoking decreases circulation and negatively affects lung function. Smoking is linked to many diseases, such as cancer, coronary artery disease, strokes, emphysema and other lung diseases. All of these reduce immune function.

2. Avoid excessive alcohola. Alcohol reduces immune system function by negatively affecting the digestive system, circulatory system, respiratory system, and decreases the production of immune cells.

3. Get adequate sleepa. Inadequate sleep may increase your risk of illness, including diabetes, obesity and heart disease. Most adults should aim for a minimum of 7 hours of sleep per night.

4. Minimize stressa. Cortisol is the hormone released during periods of high stress; it is known to suppress the immune system.b. To moderate your stress response, use relaxation techniques that are most effective for you - these can include yoga, meditation, prayer, listening to music, reading, walking, talking with a friend.c. Laughter is a great form of stress relief. It enhances oxygen uptake stimulating the heart and lungs and increases endorphins, thereby soothing tension and reducing stress.

5. Eat a diet high in fruits and vegetablesa. Recommended daily servings of fruit = 2+ (1 serve = 1 raw fruit, 1 cup of berries, or 1 cup of juice)b. Recommended daily servings of vegetables = 5+ (1 serve = 1 cup raw or cup cooked vegetables)c. Whole plant foods contain antioxidants, a substance that protects cells against the potentially damaging effects of free radicals. Antioxidant rich foods include blueberries, pecans, dark chocolate, strawberries, artichokes, goji berries, raspberries, kale, red cabbage, beans, beets, and spinach.

6. Encourage healthy gut floraa. 70% of our immune system is located within the gut. To encourage good gut bacteria, eat plenty of fibrous foods and pre-biotic foods such as, bananas, chicory, and flax seeds.b. Fruits and vegetables are excellent sources of fiber, helping to reduce constipation and improve gut microbiome.

7. Eat healthy fatsa. Healthy fats, like those found in avocados, olive oil, or salmon, may boost the bodys immune response to pathogens (bacteria and viruses) by decreasing inflammation.

8. Consume sugar sparinglya. Sugar significantly reduces the ability of white blood cells to destroy pathogens.

9. Exercise regularlya. Moderate exercise improves the immune system by stimulating the lymphatic system. The lymphatic system houses immune cells that kill off abnormal cells and harmful substances. Muscle contractions during exercise works as the pump for the lymphatic system, so that it flows more effectively and potentially prevents infections.b. Intense bursts of exercise and prolonged training should be avoided when you feel unwell as this can depress the immune system - reduce training if presenting with excessive fatigue.

10. Proper hygienea. Wash your hands regularly, the Center for Disease Control (CDC) recommends lathering with soap and scrubbing for 20 seconds.b. When you dont have access to soap and water, use an alcohol-based hand sanitizer (>60% alcohol)c. Decontaminate frequently touched surfaces by wiping down with disinfectant.

The contents of the Health site are for informational purposes only and should not be treated as medical, psychiatric, psychological, health care or health management advice. The materials herein are not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this site. Reliance on any information provided herein is solely at your own risk.

A special thanks to the author, Dr Jenifer Maynard, WTA Medical Advisor.

Original post:
Physically Speaking: The facts about COVID-19 - WTA Tennis

During the rare moments youve ventured outside these days, youve probably noticed clearer skies and the benefits of reductions in air pollution.

Long-term exposure to air pollution increases the danger associated with four of the biggest Covid-19 mortality risks: diabetes, hypertension, coronary artery disease and asthma. It also can make the immune system overreact, exaggerating the inflammatory response to common pathogens.

But there are other common contaminants in our homes that are also likely to be hacking our immune systems, which have had less attention.

Youve probably heard about synthetic chemicals in non-stick pans, cosmetics and aluminum cans disrupting our hormones. The notion of endocrine-disrupting chemicals was only widely accepted about a decade ago, when scientific societies raised the alarm. The science of immune disruption is even newer, with a large review in a major scientific journal just out last year.

You may have heard of forever chemicals, or perfluoroalkylsubstances (PFAS) from the movie Dark Waters, with Mark Ruffalo. These chemicals, used to keep food from sticking to surfaces and our clothing free of oily stains, are widely found in the US water supply. Were talking about chemicals that 110 million Americans drink each day that increase the death rate of mice exposed to influenza type A. Children exposed during pregnancy have worse immune responses to vaccines, with weaker antibody responses. Studies in Norway, Sweden and Japan have found greater difficulties in children with various infections, ranging from colds to stomach bugs to ear infections.

Bisphenol A, or BPA, which is found in thermal paper receipts and aluminum can linings, has been found in the laboratory to increase the bodys release of a molecule called interleukin-6, or IL-6, that may be involved in the raging wildfire inside the lung that has already killed so many from coronaviruses. One of the more promising treatments for coronavirus patients is tocilizumab, an antibody to IL-6. Phthalates, used in cosmetics, personal care products and food packaging, alter levels of cytokines, which are key players in the immune response to coronavirus.

Is the evidence perfect? Hardly. And we have to rely on observational studies you cant run a randomized controlled trial of potentially toxic mixtures of virus and chemical exposures. There are ethical and logistical challenges to running these kinds of studies. But absence of evidence doesnt mean absence of harm.

Will preventing these exposures now change exposure to the novel coronavirus? No. Stay home, wash your hands with soap and water at least 30 seconds at a time, and keep your social distancing game strong. Right now, we need to keep as calm as we can and carry on as best we can. Weve overcome other disasters 9/11, Katrina and Sandy, to name just a few. And once we return to normal, we can limit these exposures in our daily lives using cast iron and stainless steel instead of nonstick pans, avoiding canned food consumption, and reducing the use of plastic in our lives.

But when we return to normal, we have to ask ourselves how and why we got here, just like we did for those disasters. West Nile, Zika, dengue, Ebola and other infections are on the rise, and they are attacking us when our immune defenses are being attacked by preventable contaminants in the environment. Government and industry have dragged their feet time and again to limit these exposures because of intense economic pressure. Youve probably heard that the US Environmental Protection Agency (EPA) has used the coronavirus pandemic to waive its enforcement rules, allowing companies to pollute without consequences.

But its not just at the EPA where science has undermined human health over chemicals that can affect the immune system. The Food and Drug Administration (FDA) has failed to protect kids from known hazards in food packaging and other contact surfaces, allowing industry to vouch for safety without careful study of potential adverse effects. And when negative effects are found, the FDA is limited in its ability to require companies to stop using toxic ingredients in its materials.

Infections are not just something we vaccinate away or treat. New infections will emerge even more in the future if we dont appreciate the consequences of messing with Mother Nature and realize our immune systems are being hacked, too.

Leonardo Trasande is Jim G Hendrick MD professor of pediatrics at NYU Grossman school of medicine, and the author of Sicker, Fatter, Poorer, which describes the effects of endocrine-disrupting chemicals on human health and the economy and what we can do about it. Akhgar Ghassabian is a physician-epidemiologist in the department of pediatrics at NYU Grossman, where she studies the effects of synthetic chemicals on immune function and childrens health

More:
The toxic chemicals in our homes could increase Covid-19 threat - The Guardian