Losing a parent to cancer is so hard. On Mothers Day, Kevin Hart paid tribute to his mom, Nancy, who died of ovarian cancer in 2007. He also joined his wife, Eniko, and children wearing pink and white to reveal the gender of their upcoming baby a girl. Happy Mothers Day to this beautiful woman & wife of

mine. we are thrilled about the arrival of our baby girl.Family of 6 WOOOOOOOOW!!!! God is unbelievable.We are blessed to have you in our lives, Hart wrote on Instagram. All I can say is thank you honey.

With no screening test for ovarian cancer, its among the more difficult cancers to diagnose early. Symptoms include abdominal bloating or swelling, quickly feeling full while eating, weight loss, pelvic discomfort or pain, constipation, or a frequent need to urinate but theyre so non-specific that the disease often goes undetected.

RELATED:Exciting Developments in Immunotherapy for Ovarian Cancer

But treatment advances, including genetic testing, minimally invasive surgical techniques, and PARP inhibitor drug therapies have improved the outlook for patients diagnosed today, compared to 2007, when Nancy Hart was fighting the disease over a decade ago.

Experts urge women diagnosed with ovarian cancer, to seek genetic testing at the time of diagnosis, not recurrence. A recent study found that too few women are being tested for mutations of the BRCA gene, like BRCA1 or BRCA2. The presence of these mutations guides treatment decisions and identifies whether patients and family members at a heightened risk for breast cancer or ovarian cancer.

All women diagnosed with ovarian cancer should undergo genetic testing, says Dr. UrsulaMatulonis, Chief of the Division of Gynecologic Oncology at Dana-Farber Cancer Institute.

Ovarian cancer usually develops in women who are post-menopause. But younger women may also get the disease, especially if they carry the BRCA-1 or BRCA-2 genes.

A woman who inherits the BRCA1 gene has a 44% lifetime risk (by age 80) for developing ovarian or fallopian tube cancer, and 70-80% risk of developing breast cancer. With the BRCA2 gene, the risk for ovarian and fallopian tube cancer is 17% higher, while the breast cancer risk is around 70%

Minimally invasive surgical techniques, including robotic surgery using the da Vinci Robot, can benefit about half of women diagnosed with ovarian cancer. These new approaches allow surgeons to be more precise in pinpointing and removing ovarian cancer, which may have spread to surrounding organs. The smaller incisions also help decrease post-operative pain and speed recovery time for patients.

Dr. Allan James (A.J.) White a gynecologic oncologist at the START Center for Cancer Care in San Antonio, Texas, has seen robotic surgery dramatically change ovarian cancer treatment.

Robotic surgery uses cameras and special robotic surgery tools to make it possible for surgeons to operate through a series of small incisions. For ovarian cancer, doctors make about five incisions, each less than a centimeter in size, around the belly button rather than a large open incision down the abdomen midline.

RELATED: Considerations Before And After Ovarian Cancer Surgery

The robotic surgery presents high costs for the medical system, but Dr. White says its so good for the patientsthat, around the country and really around the world,most of us have been shifting to using the robotic techniquewhen its appropriate. For patients, the higher cost of robotic surgery may be offset by decreased hospital time, as its often possible to go home on the day of surgery or shortly thereafter.

Minimally invasive surgery is most appropriate when the disease is focused in the pelvis. Robotic surgery is not an option for every woman with ovarian cancer, saysDr. Lori Weinberg, gynecologic oncologist with Minnesota Oncology.

RELATED:The Robotic Surgery Option for Ovarian Cancer Patients

Most patients with ovarian cancer have disease that is spread out in multiple places, where the robotic platform just cannot achieve what we can do through an open incision, she explains. We really have to tailor our approach to treatment based on what were seeing from the imaging, and also on a patients physical exam.

PARP inhibitors can be a beneficial treatment option for many women with ovarian cancer. These oral drugs work by preventing ovarian cancer cells from repairing DNA damage, which prevents them from continuing to divide and spread.

Amanda Westwood, a physician assistant at UT Southwestern Medical Center in Dallas, Texas. Westwood describes these different potential options:

Recent research confirms that most women with ovarian cancer can benefit from PARP inhibitors, Amanda Westwood, a physician assistant at UT Southwestern Medical Center in Dallas, Texas,although the timing of that benefit can vary depending on her cancers genetic profile, among other factors.

RELATED:PARP Inhibitors for Ovarian Cancer: Understanding the Options

The PARPs have a huge importance in treating ovarian cancer, whether it be upfront maintenance for our BRCA patients or a recurrence setting if theyve had a partial or complete response, and even down the line they can be used as treatment alone, says Amanda Westwood, a physician assistant at UT Southwestern Medical Center in Dallas, Texas.

Westwood describes these different potential options:

After beginning treatment with PARP inhibitors, most women will go in for frequent tests to monitor their tolerance and make sure that the side effects are managed. While some women may experience nausea, the most common side-effect is fatigue. The drugs may also impact blood counts; another reason for close monitoring with lab work.

RELATED: PARP Inhibitors: A Game Changer in Ovarian Cancer Treatment

Over time, these tests may become less frequent.While some women may experience nausea, the most common side-effect is fatigue. But most of the time, patients tolerate PARP inhibitors fairly well, Westwood says.

PARP inhibitors can have a positive impact on progression-free survival, a term doctors use for living with ovarian cancer for a period of time without seeing it spread or progress.

Learn more about SurvivorNet's rigorous medical review process.

Constance Costas is a writer for SurvivorNet.

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Kevin Hart Lost his Mom, Nancy to Ovarian Cancer Now, He Reveals Baby Girl, As Treatment Advances Bring Hope - SurvivorNet

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This Autologous Stem Cell and Non-Stem Cell Based Therapies Market research document predicts the size of the market with information on key vendor revenues, development of the industry by upstream & downstream, industry progress, key companies, along with type segment & market application. This market study takes into account a market attractiveness analysis, where each segment is benchmarked based on its market size, growth rate, and general attractiveness. Another major section of this Autologous Stem Cell and Non-Stem Cell Based Therapies Market report is the competitive landscape which provides a clear insight into the market share analysis and actions of key industry players. Quality and transparency is strictly maintained while carrying out research studies to offer an exceptional market research document for your niche.

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Some of the major players operating in the globalautologous stem cell and non-stem cell based therapies marketareAntria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

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Market Definition:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease.

According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

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The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

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High cost of autologous cellular therapies

Lack of skilled professionals

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Covid-19 impact on Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020 Industry Research, Share, Trend, Industry Size, Price, Future...

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Irvine May 12, 2020 (Thomson StreetEvents) -- Edited Transcript of Chromadex Corp earnings conference call or presentation Monday, May 11, 2020 at 8:30:00pm GMT

* Kevin M. Farr

* Robert N. Fried

H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate

Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research

B. Riley FBR, Inc., Research Division - Senior Analyst

Ladies and gentlemen, thank you for standing by, and welcome to ChromaDex Corporation's First Quarter 2020 Earnings Conference Call. My name is Julianne, and I will be the conference operator today. (Operator Instructions) As a reminder, this conference call is being recorded.

This afternoon, ChromaDex issued a news release announcing the company's financial results for the first quarter 2020. If you have not reviewed this information, both are available within the Investor Relations section of ChromaDex's website at http://www.chromadex.com.

I would now like to turn the conference over to Brianna Gerber, Vice President of FP&A and Investor Relations. Please go ahead, Ms. Gerber.

Thank you. Good afternoon, and welcome to ChromaDex Corporation's First Quarter 2020 Results Investor Call.

With us today are ChromaDex's Chief Executive Officer, Rob Fried; Founder and Executive Chairman, Frank Jaksch; and Chief Financial Officer, Kevin Farr.

Today's conference call may include forward-looking statements, including statements related to ChromaDex's research and development and clinical trial plans and the timing and results of such trials; the timing of future regulatory filings, the expansion of the sale of TRU NIAGEN in new markets, future financial results, business development opportunities, future cash needs, ChromaDex's operating performance in the future and future investor interest that are subject to risks and uncertainties relating to ChromaDex's future business prospects and opportunities as well as anticipated results of operations. Forward-looking statements represent only the company's estimates on the date of this conference call and are not intended to give any assurance as to actual future results. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties. Many factors could cause ChromaDex's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These risk factors include those contained in ChromaDex's quarterly report on Form 10-Q most recently filed with the SEC. Please note that the company assumes no obligation to update any forward-looking statements after the date of this conference call to conform with the forward-looking statements, actual results or to changes in its expectations.

In addition, certain of the financial information presented in this call references non-GAAP financial measures. The company's earnings presentation and earnings press release, which were issued this afternoon and are available on the company's website, present reconciliations to the appropriate GAAP measures.

Finally, this conference call is being recorded via webcast. The webcast will be available at the Investor Relations section of our website at http://www.chromadex.com.

With that, it's now my pleasure to turn the call over to our Chief Executive Officer, Rob Fried. Rob?

--------------------------------------------------------------------------------

Robert N. Fried, ChromaDex Corporation - CEO & Director [3]

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Thank you, Brianna. Good afternoon, everyone, and thank you for joining our first quarter 2020 investor call. I hope everyone listening is navigating well these troubling times.

ChromaDex had another strong quarter with total net sales of $14.3 million. Overall sales increased 10% sequentially and 43% year-over-year. TRU NIAGEN net sales were $11.1 million, a 10% increase sequentially and a 50% increase year-over-year.

Sales to Watsons were down slightly compared to the prior quarter due to the impact of the coronavirus and the protests on retail traffic in Hong Kong stores.

Importantly, our efforts in reducing costs continued to show positive results as adjusted EBITDA, excluding total legal costs was a net loss of $316,000.

ChromaDex reacted swiftly when the coronavirus hit. We already understood that there is an impact on NAD when viruses are present, but we immediately initiated preclinical research in the area in the first quarter, led by our Chief Scientific Adviser, Dr. Charles Brenner. And as you may have noticed, Dr. Brenner published promising results in the initial preclinical study last month. Further research is required and further research is underway.

Additionally, we adjusted our marketing messaging in the first quarter to include the impact that lifestyle, viral and age-related stressors have on our NAD levels and our cellular health. This, in addition to the existing messages of cellular energy, cellular repair and aging.

And finally, we stepped up our ongoing efforts to streamline costs.

With regard to the overall outlook for the year. It is still not clear if COVID '19 will be positive or negative for our business. We're currently expecting a reduction in our top line growth, but improvement in the bottom line results relative to the outlook presented last quarter. This includes some recent changes to our organization as well as some ongoing initiatives across our supply chain. Kevin will provide additional context when he discusses our financial outlook for the year.

Let's now get to the 3 pillars of our business strategy: build a global brand, to own the science, and to focus on the fundamentals. First, the brand. As mentioned, global TRU NIAGEN net sales were $11.1 million in the quarter, a 10% increase sequentially and a 50% increase year-over-year. TRU NIAGEN represented 78% of the $14.3 million in the quarter.

International sales for TRU NIAGEN represented approximately 29% in the first quarter. This includes sales to Watsons in Hong Kong and Singapore, but also cross-border sales in China, Japan, Europe and sales to our partners in Australia, New Zealand, U.K. and Canada.

Sales to Watsons were $1.8 million in the first quarter, a slight decrease versus the previous quarter. Lower sales in the base business in the first quarter were largely offset by shipments for TRU NIAGEN Beauty, which launched in stores in late April. TRU NIAGEN beauty builds on the success of the TRU NIAGEN brand is an award-winning and best-selling health product among Watsons' Hong Kong loyalty members as well as driver of their health care category. The NIAGEN Beauty will allow us to reach new demographics seeking our science-based solutions for their beauty routines. We're pleased to extend our product portfolio with a strong partner like Watsons.

At this time, there are no plans to extend TRU NIAGEN Beauty beyond the region. E-commerce net sales were $8.2 million, a 4% increase sequentially and a 39% increase year-over-year. Sales from returning customers in the U.S. continue to outpace the new customer sales.

In addition, we have cross-border sales in the U.K., Japan, Korea, Germany, France and China, which grew 179% year-over-year. Currently expanding distribution to include 2 of China's largest online retailers, Kaola and JD.com in the second quarter. These platforms will complement our existing Tmall presence in China.

We also added 2 European cross-border markets in the first quarter following the EFSA approval, France and Germany.

Additionally, we're continuing to build our brand with strong global partnerships. We shipped initial orders to the Australia, U.K. and Persona Nutritions in the first quarter, expanding our partnerships with Matakana Superdrug in the U.K., a division of the A.S. Watson Group and Nestl Health Science, respectively.

In late April, we announced that our U.K. partner is Superdrug, a leading health and beauty retailer with over 800 stores in the U.K. and a member of the A.S. Watson Group. This represents our entry into the European market, and we're proud to expand our partnership with the A.S. Watsons Group. As mentioned last quarter, the initial launch is a small test launch in 200 Superdrug stores across the U.K. as well as superdrug.com. We very much applaud the efforts of Superdrug and Watsons for keeping essential items such as TRU NIAGEN available to customers worldwide during this unprecedented time.

We built upon our relationship with Matakana to include exclusive distribution rights in Australia in online and retail channels. Matakana is an established dietary supplement manufacturer and distributor with more than 90 lines of organic and Superfood products. TRU NIAGEN complements, Matakana's existing portfolio of products and their broad distribution as well as knowledge of our science-based product, this positions the brand for strong growth in Australia. We are partnering with them on a number of influencers, social media and earned media initiatives to drive awareness and sales in the market.

We're very much looking forward to the Nestl Health Science, TRU NIAGEN product later this year, which will emphasize the importance of cellular nutrition. As I previously said, the initial test launch will be in loose powder format, and Nestl plans to begin initial marketing efforts next month.

Persona Nutrition, the division of Nestl Health Science launched TRU NIAGEN in the first quarter. Persona is the leader in the fast-growing area of personalized nutrition. We believe it is a growth opportunity for TRU NIAGEN and one that also helps build the brand.

Our second core objective is to own the science. We are confident in the science behind NIAGEN and are actively tracking the increasing volume of research on the molecule that is currently underway. Several new studies have been registered and published since our last update. Frank will summarize in a moment.

Recently, we announced the first round of results of a combination issue, an in vitro study led by Dr. Charles Brenner, our Chief Scientific Officer; one of the world's foremost experts in NAD research as well as Dr. Stan Perlman, one of the leading experts on coronavirus. Dr. Brenner's preclinical study showed 2 key findings: one, a COVID-19 introduction to the studied cells caused greater than threefold reduction in NAD; and two, these infected cells specifically sought out nicotinamide riboside, NIAGEN in an attempt to replenish NAD levels in the face of the viral infection. We expect additional research from Dr. Brenner to be made public soon.

The next phase of his preclinical research will explore whether introducing nicotinamide riboside, or NIAGEN, may support cells innate immune response to coronaviruses and other viruses. We will publicly share the findings of this research when appropriate. We are also exploring additional preclinical research on nicotinamide riboside, or NIAGEN and COVID-19 through our industry-leading ChromaDex external research program.

We also continue to build upon and protect our intellectual property, which includes our ongoing litigation against Elysium Health. A May 12 trial date for the California Litigation was postponed due to court closures in the wake of the coronavirus outbreak. We recently submitted a written joint status report, and the court granted our request for a status conference in June.

New York, discovery has been extended by 4 months due to restrictions on taking depositions in the wake of the coronavirus. And in Delaware, regarding patent infringement by Elysium, it has been scheduled for trial on September 27, 2021. Moving forward following the recent Court of Appeals decision that upheld the validity of the Dartmouth patent, which is licensed by ChromaDex.

To remind everyone, Elysium could not appeal the rejection of their challenge to the 807 patent. Now that Elysium lost their appeal of the PTAB decision validating the 086 patent. Elysium cannot raise those same arguments in the patent infringement lawsuit regarding any claims on the 086 patent. We remain confident in the facts of all 3 cases and are eager to get to trial.

In the meantime, we expect lower near-term legal expense with delays attributable to the coronavirus.

Our third strategic pillar is to focus on fundamentals. It is our mission to lead by example of this industry. During the time when the world is looking for new solutions to maintain their health, we strongly encourage consumers to choose trusted brands, supported by published scientific data with regulatory approvals. We continue our basic philosophy of science-based marketing and conservative financial management. We recently announced the $5 million capital raise to provide some further strength to the already strong balance sheet.

In summary, in the wake of the coronavirus, we are successfully driving the business forward. We are leading important research in the field, delivering on incremental growth opportunities and adjusting our cost structure, maintaining a strong balance sheet. I believe ChromaDex will be even stronger once this global macroeconomic crisis is behind us.

And now I will pass the call over to our Chairman, Frank Jaksch, for an update on scientific research. Frank?

--------------------------------------------------------------------------------

Frank Louis Jaksch, ChromaDex Corporation - Co-Founder & Executive Chairman [4]

--------------------------------------------------------------------------------

Thank you, Rob. As Rob stated, one of our core objectives is to own the science. We are committed to remaining a global scientific authority on NR and NAD research as well as setting the standard for excellence in the industry with our commitment to science, safety and quality.

Last call, publication of research on NR and NAD has continued to accelerate with the publication of the Ninth Human Trial and multiple preclinical studies.

As Rob mentioned earlier, Dr. Brenner and scientists from the University of Iowa, Oregon Health and Science University and the University of Kansas recently published preliminary preclinical research on the potential impact coronavirus has on NAD levels in cell, animal and human tissue. The findings were published on BioArchive, a preprint server. The researchers characterized the key steps in what happens in a coronavirus infected cell and the impact it has on a innate immunity.

Before moving on, I want to briefly discuss the concept of a innate versus acquired or adaptive immunity. Acquired immunity is where the body's immune cells have developed specific antibodies after being exposed to a virus and they can quickly seek out the virus and destroy it before it can spread infection. This is how vaccines work using the acquired or adaptive immune response to protect us from viruses.

In contrast, innate immunity is where the cells go to work to fight off the infection when it is first introduced to the body. The body mobilizes immune cells to seek out, attack and destroy the virus. What we've learned from these early publications is that NAD is important for the initial innate or nonspecific response. However, further preclinical research is required in those preclinical studies are underway.

There are 40 ongoing, completed and published clinical trials currently registered on clinicaltrials.gov to investigate the pharmacokinetics and the therapeutic effects of NR. This is 1 more than our last update. An additional 9 clinical trials are registered to test NR in combination with other ingredients for a total of 49. We finished the quarter with 195 signed research collaborations, up by approximately 10 compared to last quarter.

I highlighted an interesting recent published study on NR since we last spoke. In April, a preclinical study demonstrating the effects of both niacinamide and our product, nicotinamide riboside. Supplementation on cardiac electrophysiology was published in the Journal of Molecular and Cellular Cardiology. Researchers from the University of Iowa were able to demonstrate that both NR and NAM increased NAD and NADH levels. However, only NR indicated a potential cardiovascular effect. These results reinforce earlier preclinical findings that suggest increased NAD levels may have a beneficial impact on cardiac conditions and arrhythmias. The researchers concluded that the results warrant further investigation into NR as a potential therapy for cardiac arrhythmic disorders.

Finally, I'll briefly touch on the newly registered clinical studies, all of which were registered in April. First, a study was registered by Ko University Hospital in Turkey to establish metabolic improvements in obese patients with nonalcoholic fatty liver disease, or NAFLD. Through dietary supplementation of NR with the combination of serine, L-carnitine and N-cacetylcysteine. Previous studies have suggested that each of these nutrients decrease liver fat. Thus, the researchers hypothesized that supplementation of a combination of these ingredients, including NR, will stimulate pathways to enhance hepatic oxidation, resulting in decreased liver fat.

Additionally, a pilot study was registered by the Cleveland Clinic, a comprehensive cancer care center to investigate the effects of nicotinamide riboside supplementation in allogeneic hematopoietic cell transplantation. The objective is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding NR to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment.

Before turning the call over to Kevin, I'd like to briefly discuss our new framework for categorizing the areas of ongoing research on NR. In the past, I have discussed studies categorized by various health conditions such as heart health or cardiovascular health, brain health or neurological health, liver health as well as many others. At ChromaDex, we've begun to frame the discussion in the context of a new way of looking at health called intrinsic capacity, which is part of the World Health Organization's framework for healthy aging.

According to WHO, intrinsic capacity is the composite of all mental and physical capacities that a person can draw on, including their ability to walk, think, see, hear and remember. It is an indicator of one's ability to cope with physiological stress and still maintain these functions. We categorize these concepts into 5 domains of intrinsic capacity, vitality, cognition, locomotion, sensory and psychological. In other words, intrinsic capacity is defined by the underlying health of our cells. Nutritional solutions such as NR represent an opportunity to help maintain or even improve intrinsic capacity.

We've included a slide in our earnings presentation, illustrating how cellular health supports intrinsic capacity. Going forward, I'll be presenting the summary of ongoing clinical studies in these intrinsic capacity domains consistent with our internal framework.

In summary, ChromaDex is committed to remaining the leader in the NR, NAD and cellular health conversation. As Rob mentioned, Dr. Brenner's preclinical research is ongoing, and we will provide updates when appropriate.

With that, I'll pass the call over to Kevin Farr. Kevin?

--------------------------------------------------------------------------------

Kevin M. Farr, ChromaDex Corporation - CFO [5]

--------------------------------------------------------------------------------

Thank you, Frank. Let's look at our financial results for the first quarter of 2020, which reflected continued progress against our key financial objectives and strong underlying business performance. The underlying business is measured by adjusted EBITDA, excluding total legal expense, approached breakeven in the first quarter with a loss of $316,000. This was a $1.8 million improvement sequentially and a $2.4 million improvement year-over-year. Compared to the fourth quarter of 2019, we delivered strong sequential top line growth, higher gross margins, significant lower advertising expense as a percentage of net sales and lower general administrative expenses primarily driven by the absence of Elysium-related debt expense in the current quarter, partially offset by higher severance and restructuring charges, which are related to cost savings initiatives.

In April, we strengthened our balance sheet with a $5 million common stock raise from existing strategic investors. While there was not an immediate need for the additional capital, we believe it's prudent given the current economic uncertainty. We're always opportunistic if an investor wants to invest capital into the company, and it benefits all of our shareholders.

With this additional $5 million, based upon our current outlook, we believe we have enough cash to reach cash flow breakeven and defend our intellectual property, excluding our $7 million committed line of credit. The line of credit provides additional financial flexibility.

Moving to the first quarter results. For the 3 months ended March 31, 2020, ChromaDex reported net sales of $14.3 million up 10% compared to the $13.1 million in the fourth quarter of 2019. Year-over-year net sales were up 43% compared to the first quarter of 2019.

TRU NIAGEN net sales were up 10% sequentially and grew by 50% year-over-year with diversified growth across U.S. e-commerce, Watsons and international cross-border launches year-over-year. Watsons' sales remained solid at $1.8 million in the quarter, but were down slightly versus last quarter. As expected, Watsons' experienced softer consumer takeaway in the first quarter due to store closures in the wake of the coronavirus. As the economy began to reopen in March, these trends improved, but have yet returned to prior levels. As Rob mentioned, we also shipped our new product TRU NIAGEN Beauty in the quarter, which aligned with Watsons' late April launch. We expect continued impact on sales to Watsons in the second quarter due to the coronavirus.

Total NIAGEN-related net sales were up 8% sequentially and 53% year-over-year. We've experienced strong demand for NIAGEN from our customers.

Turning to the rest of the P&L. On a sequential basis, our gross margin was up 90 basis points from 57.0% in the fourth quarter of 2019 to 57.9% in the first quarter of 2020. Year-over-year gross margin increased by 520 basis points to 57.9% compared to 52.8% in the first quarter of 2019.

As a reminder, last year, we recorded a 250 basis point charge related to the wind down of our purple corn ingredient sales. Product cost savings initiative and overall scale in our supply chain drove the improvement in gross margins. We believe both factors as well as favorable mix from growing TRU NIAGEN consumer product sales represent a tailwind to gross margins in 2020.

On a sequential basis, our total operating expenses for the first quarter of 2020 was $14.2 million, down $2.1 million compared to the fourth quarter of 2019. As a reminder, the fourth quarter of 2019 included a onetime bad debt charge of $2.2 million related to the full write-off of our Elysium receivable.

Our selling and marketing expenses were down $0.7 million to $4.4 million in the first quarter of 2020 compared to $5.1 million in the fourth quarter of 2019. As a percentage of net sales, this expenditure was down 800 basis points in the first quarter of 2020 versus the fourth quarter of 2019.

We made continued progress, improving marketing efficiency in our TRU NIAGEN business driven by strong returning customer growth while investing in initiatives to drive new customer growth, both in the U.S. and internationally. We continue to monitor daily e-commerce metrics such as customer acquisition costs to adjust messaging and spending, which is increasingly important in this fluid environment.

As reported, G&A expense was down $1.3 million to $8.8 million in the first quarter of 2020 versus $10.1 million in the fourth quarter of 2019. This included $2.4 million of legal fees and $1.0 million of severance and restructuring expenses in the current quarter. Excluding legal fees, severance, restructuring and equity compensation expense, first quarter 2020 G&A expense was lowered by $0.1 million versus the fourth quarter of 2019 comparable G&A expense, which also excluded Elysium-related bad debt expense.

Legal expense was up slightly compared to the fourth quarter of 2019. Motions for summary judgment when we decided following hearings in the California matter during the first quarter, and discovery accelerated in the New York litigation.

Sequentially, the trial was delayed in California case due to the suspension of all jury trials caused by the coronavirus. For the same reason, deposition discovery was delayed in New York.

As a result, we expect legal expense to be lower in the second quarter of 2020 despite ongoing investments in the Delaware patent infringement case in preparation for the Markman Hearing in December 2020, and the trial in September 2021.

For the first quarter of 2020, our operating loss was $5.9 million versus $8.9 million in the fourth quarter of 2019, which included the $2.2 million bad debt write-off. The net loss attributable to common shareholders for the first quarter of 2020 was $5.9 million or a loss of $0.10 per share as compared to the net loss of $8.9 million or a loss of $0.15 per share for the fourth quarter of 2019. The fourth quarter of 2019 net loss per share included the $0.04 per share bad debt expense.

As we said, we believe it's important to focus on sequential trends in our business to demonstrate progress towards cash flow breakeven. To help investors better engage the underlying performance of our business in the second quarter of 2019, we introduced a new non-GAAP measure adjusted EBITDA, excluding total legal expense. ChromaDex defines adjusted EBITDA, excluding total legal expense as net income or loss, which is adjusted for income tax, interest, depreciation, amortization, noncash stock compensation costs, bad debt expense related to Elysium, severance and restructuring expenses and total legal spending. We have included a reconciliation to the appropriate GAAP measures in our earnings release slide.

Litigation expenses represents the majority of our legal spend today. We are excluding total legal spending from adjusted EBITDA since we expect to decline significantly after the matters are concluded.

In the fourth quarter of 2019, we began excluding severance and restructuring expenses that we expect to deliver measurable, sustainable net cost savings in late 2020 and beyond. We made changes to the organization in the first quarter and completed negotiations as part of our end-to-end supply chain evaluation.

On an annualized basis, we identified at least $2 million of gross savings, with the majority of the savings delivered to be realized in 2021. We incurred $1.2 million of severance and restructuring expenses related to these cost savings initiatives. As is prudent in this uncertain economic environment, we'll continue to evaluate our cost structure and see additional opportunities in our supply chain.

As I previously highlighted, adjusted EBITDA, excluding total legal expense improved by $1.8 million to a loss of $0.3 million in the first quarter of 2020 compared to a loss of $2.1 million in the fourth quarter of 2019.

Year-over-year, we delivered a $2.4 million improvement in the first quarter of 2020 versus a loss of $2.7 million in the first quarter of 2019. The improvement in the first quarter of 2020 was primarily driven by higher sales and gross margins and marketing efficiency.

Moving to the balance sheet and cash flow. We ended the first quarter of 2020 with cash of $13.6 million, down $5.2 million versus the fourth quarter of 2019.

In the first quarter of 2020, our net cash used in operation was a negative $5.2 million versus a negative $0.6 million in the fourth quarter of 2019.

Consistent with our expectation, the higher cash outflows from operations this quarter was driven by working capital, which is a $1.6 million use of cash in the first quarter of 2020 compared to a $3.9 million source of cash in the fourth quarter of 2019. The use of cash in the first quarter was related to an increase in accounts receivable and a decrease in accounts payable, largely due to lower NIAGEN ingredient purchases.

Today, we've successfully navigated the business during the coronavirus pandemic. At this time, we do not expect any supply to change disruptions from coronavirus and have implemented risk assessment strategies to manage this going forward.

As it relates to revenues, the COVID-19 situation remains fluid and difficult to predict. Against this backdrop, we are managing our expenses to mitigate the bottom line impact to the company.

As Rob said, we took a hard look at our 2020 financial plan to ensure we're prioritizing investments with the highest return in the current environment.

For full year 2020, we expect continued top line growth driven by our U.S. e-commerce business, launches in new international markets such as the U.K. and Australia, and launches on new platforms such as Persona Nutrition. As we have said, we anticipate a lower growth rate than the 47% in 2019 due to: a larger revenue base, the impact of the coronavirus and the impact to divesting our Spherix regulatory consulting business, which accounted for roughly $700,000 of 2019 net sales.

As Rob mentioned, we see the coronavirus having impact on Watsons in the second quarter. There has also been a modest impact in our HCP business where some sales are tied to trade shows, which have been canceled.

COVID-19 may also impact our international market launches at retail, but these are incremental opportunities relative to 2019. It's too early to determine the impact of the coronavirus on our e-commerce sales. Consumers are likely to balance concerns about employment, overall macroeconomic weakness with their desire to invest in their health with supplements like TRU NIAGEN.

Based on the trends to date, we're planning for continued growth in this business in 2020. We continue to expect gross margin expansion due to the favorable mix from our growing e-commerce business, the product design changes implemented in late 2019 and additional supply chain cost savings initiatives.

We continue to expect an increase in selling and marketing expense of $3 million to $5 million, including investments in brand awareness and investments in new market launches. We expect continued improvement in selling and marketing expense as a percentage of net sales driven by strong sales growth from returning customers.

Go here to read the rest:
Edited Transcript of CDXC earnings conference call or presentation 11-May-20 8:30pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

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

Recommendation and review posted by Bethany Smith

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

Recommendation and review posted by Bethany Smith

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

Recommendation and review posted by Bethany Smith

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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

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A rapid-acting bone marrow transplant developed by the Israeli biotech Gamida Cell was engrafted in blood cancer patients 10 days faster than standard umbilical cord blood transplants in a phase III trial.

The trial recruited 125 blood cancer patients in more than 50 clinical centers globally. One group received a standard transplant of donor umbilical cord blood cells and another group received Gamidas treatment omidubicel, which consists of umbilical cord blood cells that are expanded and cultured in the lab.

According to the trial results, omidubicel established itself in the patients and started making healthy new immune cells after around 12 days, measured by counting cells called neutrophils in the blood. This was significantly faster than the 22 days it took in patients given a regular umbilical cord blood transplant.

Blood cancer patients often receive stem cell transplants to replace bone marrow cells that are damaged by chemotherapy or radiation therapy. Donor stem cell transplants can come from adult bone marrow cells, stem cells in the blood, or umbilical cord blood stem cells.

A common problem with bone marrow transplants is compatibility, where the donors cells could fail to engraft or even attack the recipient if the cell types dont match properly. This problem is less common in umbilical cord blood transplants than other sources, but this type of transplant also provides a lower dose of stem cells, which can delay the engraftment process.

To solve this issue, Gamida Cells treatment is designed to take donor umbilical cord cells and boost their stem cell count in the lab prior to administering the treatment to patients.

These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers, stated Mitchell Horwitz, Principal Investigator and Professor of Medicine at the Duke Cancer Institute, USA.

Shortening the time to engraftment is clinically meaningful, as it can reduce a patients time in the hospital and decrease the likelihood of infection.

The company aims to apply for FDA approval in late 2020, with a potential commercial launch in 2021. According to a conference call today, Gamida Cell had completed its phase III enrollment in December. This meant that the trial was luckily unaffected by the onset of the Covid-19 pandemic, which has delayed clinical trials for many companies worldwide.

Image from Shutterstock

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Gamida Cells Bone Marrow Transplant Cuts Treatment Time in Phase... - Labiotech.eu

Recommendation and review posted by Bethany Smith

TEL AVIV, Israel, May 11, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today announced the publication of an article in Bone Marrow Transplantation, a peer-reviewed medical journal )member of the Nature publishing house) covering transplantation of bone marrow in humans and published monthly by the prestigious Nature Research, entitled 'Ex-vivo FAS-ligand to Improve Allograft Safety'. The article is co-authored by researchers at Cellect and its academic partners.

The paper highlights the pre-clinical research and demonstrates that engraftment is robust following transplantation of treated graft, and the graft retains its immune reconstitution and anti-leukemic effects. The Company has initiated a Phase 1/2 study in adults undergoing stem cell transplant for the treatment of hematological malignancies. The primary endpoint of the study is to evaluate the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft at 180-days post-transplant. All patients transplanted through present time using the ApoGraft process were engrafted and time to engraftment was similar to the standard of care. To date, there have not been any safety and tolerability concerns during the study and patient enrollment is continuing. Both, the principal investigator (PI) and independent data safety monitoring board (DSMB) agree that no serious adverse events (SAEs) reported during the course of the study were related to the ApoGraft process.

The data from the pre-clinical research, and published in this paper, was included in the Company's Investigational New Drug (IND) application, which was approved by the U.S. Food and Drug Administration in late 2019. The Company has received all the necessary approvals to initiate the trial with its academic partner, Washington University, and plans to begin patient recruitment once the COVID-19 pandemic is mitigated and clinics can resume normal practices.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Company's ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Contact

Cellect Biotechnology Ltd.Eyal Leibovitz, Chief Financial Officerwww.cellect.co+972-9-974-1444

Or

EVC Group LLCMichael Polyviou+732-933-2754mpolyviou@evcgroup.com

View original content:http://www.prnewswire.com/news-releases/cellect-biotechnology-announces-positive-data-demonstrating-robust-engraftment-using-apograft-was-featured-in-bone-marrow-transplantation-primary-data-points-were-submitted-to-the-fda-during-investigational-new-drug-approval-proc-301056409.html

SOURCE Cellect Biotechnology Ltd.

Company Codes: NASDAQ-SMALL:APOP, TelAviv:APOP

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Cellect Biotechnology Announces Positive Data Demonstrating Robust Engraftment Using ApoGraft was Featured in Bone Marrow Transplantation; Primary...

Recommendation and review posted by Bethany Smith

The Pixion Market Research offers complete overview of the Global Bone Marrow Transplant market with marketing knowledge on the basis of recorded data for marketing decision makers. Report also focuses on all the important aspects of the industry such as new models, opportunities and trends which enable more effective marketing decision making and theories with empirical insights from marketing study. Hence the report is beneficial for the readers as it informs about the crucial parameters and market developments in order to take steps accordingly and make marketing strategies.

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There are some key segments covered in this report such as product type, application, competitive landscape and key geographies.

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The impact of Coronavirus outbreak on the market industry is explained in this report. Covid-19 outbreak has climbed rapidly and it is likely pull the market down further in the upcoming years. Thus the complete overview of the pandemic is studied to help you understand the economic impact of the virus so far. Therefore, the strategies and solutions are discussed based on assessments made by different analysts and industry experts in order to stabilize the industry condition and grow further to maintain the status in the market.

Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs.

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COVID-19 Impact On Global Bone Marrow Transplant Market New Study Of Trend And Forecast Report 2020-2026 - Cole of Duty

Recommendation and review posted by Bethany Smith

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Life science Industry, and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Stem Cell Therapy market globally. This report on Stem Cell Therapy market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

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Stem cell therapy is a technique which uses stem cells for the treatment of various disorders. Stem cell therapy is capable of curing broad spectrum of disorders ranging from simple to life threatening. These stem cells are obtained from different sources, such as, adipose tissue, bone marrow, embryonic stem cell and cord blood among others. Stem cell therapy is enables to treat more than 70 disorders, including degenerative as well as neuromuscular disorders. The ability of a stem cell to renew itself helps in replacing the damaged areas in the human body.

MARKET DYNAMICSIncrease in the number of stem cell banking facilities and rising awareness on the benefits of stem cell for curing various disorders are expected to drive the market during the forecast period. Rise in number of regulations to promote stem cell therapy and increase in number of funds for research in developing countries are expected to offer growth opportunities to the market during the coming years.

Key Players

The research provides answers to the following key questions:

The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Stem Cell Therapy market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal according to different segments. The report also predicts the influence of different industry aspects on the Stem Cell Therapy market segments and regions.

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Stem Cell Therapy Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America

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COVID-19 Impact on STEM CELL THERAPY MARKET 2020 TO 2027-EXPANDING WORLDWIDE WITH TOP PLAYERS FUTURE BUSINESS SCOPE AND INVESTMENT ANALYSIS REPORT -...

Recommendation and review posted by Bethany Smith

Hair loss is not something usually for one to worry about, however, it can be upsetting for some. At times, hair loss can be only temporary and can be caused by an illness, genetics, stress, weight loss or an iron deficiency. In others, hair loss is a normal part of getting older but what can be done to help halt the process?Dr Earim Chaudryspoke exclusively toExpress.co.ukto discuss all thingshair-relatedand what are some of the best supplements one can take to help with hair loss.

Dr Chaudry said: Approximately 30percentof men by the age of 30 and 70percentby the age of 70 are affected by Male Pattern Baldness (MPB) but it can appear as early as teenage years, particularly if there is a strong family history of early baldness.

First, a little background on male pattern baldness and how it happens.

Androgen hormones communicate to hair follicles through specific androgen receptors located at the root of the hair follicle. Interestingly, these receptors are only present on hair follicles located at the front and crown of the scalp.

They are not present on the back and sides which is why these areas are not normally affected by the process of MPB.

Genetic factors determine how active these receptors are and therefore how sensitive the hair follicles are to the effect of androgens. The gene that codes for the androgen receptor (AR) has been confirmed to play a role in MPB.

The androgen receptor (AR) gene is located on the X chromosome, which in men is inherited from the mother.

This explains the common belief that MPB is inherited from the maternal side of the family. New research supports that there are far more genetic factors, which can come from one or both parents that contribute to the overall risk of MPB.

Equally, early-onset MPB has been independently linked to metabolic syndrome and other risk factors for heart disease.

When asked what happens during the hair loss process, Dr Chaudry replied: MPBis the most common form of hair loss, caused by your genetics primarily.

It accounts for 95percentof male hair loss and is treatable. In MPB hair follicles gradually shrink, your hair becomes thinner and sheds more quickly.

At the hair follicle, there is an enzyme called 5-alpha-reductase (5AR) which changes testosterone into DHT (a more potent hormone). Hair follicles susceptible to MPB are more sensitive to DHT, and it causes them to shrink.

The hair at the back of the head is more resistant to the effects of DHT and because of receding hairlines and the crown usually are the areas of MPB."

When it comes to the best supplements one can take to help with hair loss, Dr Chaudry recommends: Part of the B family, biotin is one of several vitamins that convert nutrients from food into energy.

It plays an important role in the healthiness of your hair, as well as your skin and nails, and is one of the only natural remedies for hair loss that is backed by science.

Biotin deficiency is extremely rare, so the chances are it will not be the root cause of your hair.

However, some studies have shown that taking biotin helps speed up and increase the rate of hair growth in certainindividuals."

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Hair loss treatment: Expert reveals what you should be taking to help stimulate hair - Express

Recommendation and review posted by Bethany Smith

Back in autumn 2018, investors began piling into U.S.-based India Globalization Capital, Inc., (IGC) which had announced in September of that year the startup of a CBD beverage called Nitro G. The company had been touting a distribution deal with a partner in Malaysia that would make the business go. IGC eventually raised $30 million in a secondary offering on the New York Stock Exchange.

Due diligence: By October 29 of that year the NYSE had delisted IGCs common stock, flagging the company for promoting ventures the success of which is problematical after analysts pointed to a flaw in the companys plans. As a class action lawsuit filed against IGC in November 2018 described the strategic weakness: Plaintiffs alleged that the company failed to disclose to investors that cannabis was illegal and punishable by death in Malaysia.

Thats only one of the more colorful among pending federal class action lawsuits against cannabis enterprises in U.S. courts in which investors are crying over the money they lost blindly chasing risky stocks.

Meanwhile, as the hemp industry wobbles like any other toddler, everybody from independent farmers to big, loud public companies find themselves before the judge these days.

The claims such as those against IGC are standard fare in the public markets, particularly those companies traded as penny stocks. They generally fall into the made materially false and misleading statements category, with companies and their executives sued for allegedly lying about this or that, or forgetting to disclose some fundamental problem, causing stock prices to drop. Here are some other legal cases in the hemp and CBD sectors, most of which continue to wind their way through federal courts under U.S. securities laws:

Chewing gum conundrum: Plaintiffs allege U.S. CBD maker CV Sciences made misleading public statements about the status of a patent application for a CBD chewing gum. The patent was later rejected, hitting CVs share price. (Filed August 2018)

Some property in Jamaica: Investors allege Canada-based Aphria, Inc. paid C$193 million (US$137 million) for a bundle of assets in Jamaica, Argentina and Colombia that have virtually zero worth. Plaintiffs say the deals real purpose was to help executives siphon money from the company through a web of other deals. (Filed December 2018)

Pumpin it: Plaintiffs allege 22nd Century Group, which says it makes low-THC cannabis products, used an aggressive promotional campaign to push the companys stock price while failing to pursue U.S. Food & Drug Administration approval for any new products. The companys shares plummeted after 22nd Centurys CEO resigned amid rumors about the alleged price-pumping scheme. (Filed January 2019)

What licenses? A plaintiff group is seeking up to $4 million from cannabis producer Sundial Growers, Inc. of Canada through a lawsuit alleging the company misled them regarding the potential for CBD sales through its acquisition of Bridge Farm, a UK-based ag firm. The plaintiffs say Sundial claimed the British company held hemp farming and export licenses when in fact it did not. Sundial is also facing a number of suits in the marijuana space.

Puff puff-ery: Greenlane Holdings, Inc. has been targeted with a lawsuit for allegedly failing to disclose that the city of San Francisco was planning to ban e-cigarettes, after touting its relationship with JUUL, a San Francisco-based e-cigarette maker, causing a drop in Greenlanes share price. (Filed September 2019)

Ka-ching! Paragon Coin, Inc. of the U.S, which says it is incorporating blockchain technology into the cannabis industry, is alleged to have sold tokens that were not registered as securities. The lawsuit is yet unsettled, but SEC has in the meantime settled other charges against Paragon over its initial coin offerings, imposing a $250,000 fine and ordering investors compensated. (Filed January 2018)

How do you feel now?: Investors allege that Zynerba Pharmaceuticals, a CBD maker, mischaracterized the results of clinical trials of a transdermal CBD gel, Zygel, causing shares to suffer. Plaintiffs claim the company reported that the gel was well-tolerated among subjects who participated in the trial, while in truth nearly all patients in the trial reported mild to serious adverse effects, and eight patients discontinued the trial altogether. (Filed October 2019)

Authentic losses: Petitioners say Canadian cannabis giant Tilray violated federal securities laws by inflating the potential of a revenue sharing agreement signed with Authentic Brands Group (ABG) in March 2019. The plaintiffs say Q4 2019 results later showed charges of $112.1 million related to impairment of the ABG agreement. Tilray reported net 2019 losses of $321.2 million, or $3.20 per share. (Filed April 2020)

Gelatinous: Shareholders say Canopy Growth, also of Canada, misled them on the potential for a line of soft gels and oils, saying on a conference call that demand for the products was strong as late as November 2019. That eventually led to a restructuring charge of CA$32.7 million (US$23.2 million) due to poor sales, excessive returns and a bloated inventory. (Filed November 2019)

A marathon 5 years running: Hemp Inc. is the target of an ongoing federal case by the U.S. Securities & Exchange Commission (SEC) in which it is charged with violating securities laws. The original 2016 SEC complaint against the company and three executives charges them with committing a long-running fraud and running an illegal scheme to sell unregistered stock. A Nevada federal judge in April 2020 upheld sanctions against the three executives.

While public companies had their share of legal troubles, private enterprises also are finding themselves the subjects of claims by stakeholders as litigation in the cannabis, CBD and hemp sectors proliferates. The cases reflect the wide range of potential pitfalls at this formative stage of the industry:

Is that mold? Nevada-based Industrial Hemp Manufacturing LLC (a subsidiary of Hemp Inc. see above) sued American Hemp Seed Genetics LLC (AHSG), an Oregon company for $700,000 over a seed contract signed in April 2018, claiming that an initial shipment for which it paid $70,000 contained dead and moldy seeds, while others had a germination rate of only 24%. IHM was to sell $700,000 worth of American Hemp Seed Genetics seed under an arrangement between the two companies. AHSG in March 2020 lost an appeal to dismiss the lawsuit on jurisdictional grounds, so the case continues.

Up in smoke again: Oregonized Hemp Co. LLC and owner Justin Pitts filed a $2.5 million lawsuit against Josephine and Jackson counties in Oregon, alleging that police seized more than two tons of legal industrial hemp from his warehouse, then later destroyed the crop thinking it was marijuana. At least 5,000 pounds of plant material was seized from the greenhouse during the raid, which Pitts said was legal industrial hemp with THC concentrations at or below 0.3 percent. The lawsuit, filed in April 2020, charges civil rights and due process violations.

Pet supplies: CBD supplier Sage Fulfillment sued the pet product distributor Earth Animal Ventures in Connecticut for allegedly reneging on a purchase agreement, claiming revenue losses of $4.8 million in a total $5.95 million deal. In the suit, filed in April 2020, Sage claims Earth Animal failed to live up to its commitment to buy a minimum of 400,000 units of its CBD gel and applicator after purchasing only 75,000 units.

Facing down the Sheriff: Licensed California hemp grower Apothio LLC filed a federal lawsuit against Kern County Sheriff Donny Youngblood, California Department of Fish and Wildlife Director Charles Bonham, their agencies and other county and state officials over the destruction of nearly 500 acres of hemp plants the grower says are worth $1 billion, according to the lawsuit. The federal suit, filed in April, called authorities actions one the largest wholesale destruction of personal property by government entities in the history of the United States.

Troubles in Kentucky: Bankrupt hemp processor GenCanna faces a number of lawsuits after the Kentucky company collapsed late last year:

Integrity/Architecture, Lexington, Kentucky; general contractors Pinnacle Inc., Benton, Kentucky; and Crawford Sales, a door maker based in Evansville, Indiana, say GenCanna owes them a combined $50,000..

Lexington Certified Public Accounting firm Dean Dorton claims GenCanna owes it more than $500,000.

Agro firm Furnwood Farms is in arbitration with GenCanna after filing a lawsuit seeking $5 million last October due to losses resulting from the late delivery, and questionable quality, of cultivation seeds as well as changes in the wording of agreements made by GenCanna.

A group of construction and other contractors filed liens against property owned by the Industrial Authority of Mayfield-Graves County which is under lease to GenCanna. The contractors claim in their lawsuit, filed in October 2019, that GenCanna owes them $13 million related to a processing plant construction project in Mayfield, Kentucky.

Seed deal fails to sprout: Wisconsin hemp seed seller Legacy Hemp LLC is suing Canadian hemp firm Terramax after it tried to terminate a distribution deal for industrial hemp seed in the U.S., claiming Terramax is trying to move distribution rights to another hemp company. The conflict involves questions over which states Legacy was granted rights for distribution of Terramax X-59 hemp seeds. The suit was filed in March 2020.

Organizational matter: In another case in Kentucky, a group of farmers in April filed a $69 million class action lawsuit in U.S. federal courts, alleging Bluegrass Bio-Extracts, Owensboro, Kentucky, and owners Gerald Edds and Bruce Peters, committed fraud and violated the U.S. Racketeer Influenced Corrupt Organizations (RICO) Act by breaching a contract to buy their 2019 hemp crops.

Slanderous affair: American cannabis research firm New Frontier Data sued UK research group Prohibition Partners (PP Intelligence Ltd) and cannabis investor Andy Defrancesco in 2019 for assault libel and slander in a dispute involving rights to research and written analysis in a report on cannabis investments. The case is reported closed, but no details are publicly available.

Problem from the start: GX Farms of California sued H.E.M.P. Group of Colorado for $17 million in January 2020 over a batch of hemp seeds that failed to germinate as promised. GX said it paid $364,000 for 520,000 seeds in spring 2019. According to the suit, GX Farms paid another $25,000 to a broker who promised a germination rate of 99%. GX Farms alleges it lost $3.5 million to $17 million in potential income.

And one at the end: Oregon agri-company Jefferson State Farms has sued a cooperative for $11 million, claiming the group failed to harvest its crops as promised. Jefferson State alleges unlawful trade practices and breach of contract against Palex Enterprises, Hemp Warehouse and Great Horizons LLC, and four individuals. The farm company said it paid the co-op $136,000 as a down payment to schedule its hemp harvest, which never happened. Jefferson State claims $86,000 of that down payment has yet to be returned.

Plow it under: CBD maker Elemental Processing of Kentucky filed a $44 million lawsuit against HP Farms of Oregon, claiming HP sold it a batch of 6 million seeds that were mostly male, causing a massive crop failure in 2019 as farmers to whom Elemental distributed the seeds had to plow their hemp fields under. Elemental says it paid about $352,000 in advance for the seeds and had agreed to pay $3.5 million more or 15% of its profits from the harvested flowers. (Filed September 2019).

Heavy metal: A group of plaintiffs are seeking class action against American Shaman LLC of Missouri, claiming CBD they purchased from the company contained lead and other contaminants. The complaint accuses American Shaman of falsely advertising its CBD products as being free of heavy metals and insecticides. (Filed May 2020)

SOURCES: Goodwin Procter, Law 360, Reuters, Bloomberg Law

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The majority of the worlds mammoth remains is discovered in Russia every year. Yet, some people prefer to believe that we dont even need them as evidence because these animals are still very much alive and well.

In one of the most remote parts of Russia, in the vast Siberian taiga, one can go a hundred miles without meeting a fellow traveler. Could these territories harbor living mammoths to this day?

Some people in Russia believe its possible. Some TV programs devoted to the unknown run investigations into this question, while locals continue to occasionally circulate stories of mammoth sightings. According to one rumor from the 1940s, military pilots flew over the dense taiga in Yakutia and spotted a small herd of animals, very similar to wooly mammoths. In 1978, a similar story happened to a group of people on the Indigirka river in Yakutia. They claimed that one early morning, they woke up to about a dozen mammoths, calmly drinking from the river.

Some Russians believe that mammoths can still be found living in dense Siberian taiga.

These accounts, however, are nothing more than urban legends, like the Yeti or the Loch Ness monster, thinks Nikita Zimov, Russian ecologist and director of the Pleistocene Park in Yakutia, a project that aims to revive the natural habitat of mammoths - the northern subarctic steppe grassland ecosystem, which existed here thousands of years ago. The ultimate dream is to see mammoths walk the Earth again. (So, it stands to reason that Zimov would gladly have supported a living mammoth theory, had he really thought it possible.)

This is complete nonsense. Mammoths in the mainland of Eurasia became extinct, or rather were wiped out (by people), 9,000 years ago. The last mammoths lived on Wrangel Island until 3,380 years ago, he argues. Plus, there is no such thing as unexplored Siberian taiga anymore - over the past 200-300 years, people traversed it many times over.

If one wants to find uniquely preserved mammoth fossils, Russia is the place to go!

Why is that? Well, the permafrost in the northernmost parts of Russia is uniquely suited to the task (as if a mammoth died just yesterday), and when it melts away, the erosion of river banks or other natural factors end up exposing these remains, first for locals, and then scientists, to see.

According to the Mammoth Museum in Yakutsk, 75 percent of the world's known mammoth and related graves with preserved soft tissue were found in Yakutia.

The presentation of a stuffed young mammoth male in St. Petersburg. The remains of a 15-year-old teenage mammoth were discovered in August 2012 at the mouth of the Yenisei River in Taimyr and are estimated to be about 30,000 years old.

Mammoths used to live in the area spanning from modern Spain to Canada [there was a natural bridge that connected Eurasia to North America back then]. Where it emerged as a species I cant say, but a major part of its habitat was on the territory of todays Russia - therefore, it wouldnt be an exaggeration to call Russia a sort of a motherland of mammoths, thinks Zimov.

Yet, according to him, the number of remains found in Russia isnt a telltale sign that it harbored the largest population on the planet. It only indicates that their remains have been much better preserved here thanks to permafrost. The density of the mammoth population could have been higher on the territory of modern Spain, for example, the expert believes.

The mummified remains of mammoth "Yuka" on display in Vladivostok. Yuka, the best preserved Siberian woolly mammoth to be found so far, was discovered in the permafrost of Ust-Yana Ulus in Russia's Yakutia in 2010.

The idea of bringing the beast back from the dead seems tempting, but it looks like Russian scientists are not too involved in this area of genetic research, despite so much frozen DNA being unearthed in the country.

According to Zimov, there are three main teams who are most preoccupied with this question right now - one headed by George Church from Harvard, and two from Japan and South Korea. They have all been researching the problem since the mid-90s.

75 percent of the world's known mammoth and related graves with preserved soft tissue were found in Yakutia.

Our scientists from the Mammoth Museum in Yakutsk are also participating in this research, but their work is mostly about finding the genetic material and transporting it to labs in Japan or Korea, Zimov explains, adding that Russian genetics as a science hasnt been developing as fast as it has in other countries.

He notes that there is much more talk in the media about mammoth cloning than there is evidence to its potential effectiveness. Id personally be very happy if we saw mammoths in our Pleistocene Park. But for now, this is more like waiting for a miracle, he concludes.

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Some diseases exhibit a clear sex bias, occurring more often, hitting harder or eliciting different symptoms in men or women.

For instance, the autoimmune conditions lupus and Sjgren's syndrome affect nine times more women than men, while schizophrenia affects more men and tends to cause more severe symptoms in men than in women.

Likewise, early reports suggest that despite similar rates of infection, men are dying from COVID-19 more often than women, as happened during previous outbreaks of the related diseases SARS and MERS.

For decades, scientists have tried to pinpoint why some diseases have an unexpected sex bias. Behavior can play a role, but that explains only a piece of the puzzle. Hormones are commonly invoked, but how exactly they contribute to the disparity is unclear. As for genes, few, if any, answers have been found on the X and Y sex chromosomes for most diseases.

Now, work led by researchers in the Blavatnik Institute at Harvard Medical School and at the Broad Institute of MIT and Harvard provides a clear genetic explanation behind the sex bias observed in some of these diseases.

The team's findings, reported May 11 inNature, suggest that greater abundance of an immune-related protein in men protects against lupus and Sjgren's but heightens vulnerability to schizophrenia.

The protein, called complement component 4 (C4) and produced by the C4 gene, tags cellular debris for prompt removal by immune cells.

The team's key findings:

"Sex acts as a lens that magnifies the effects of genetic variation," said the study's first author, Nolan Kamitaki, research associate in genetics in the lab of Steven McCarroll at HMS and the Broad.

"We all know about illnesses that either women or men get a lot more, but we've had no idea why," said Steven McCarroll, the Dorothy and Milton Flier Professor of Biomedical Science and Genetics at HMS and director of genomic neurobiology at the Stanley Center for Psychiatric Research at the Broad. "This work is exciting because it gives us one of our first handles on the biology."

McCarroll is co-senior author of the study with Timothy Vyse of King's College London.

Although C4 variation appears to contribute powerfully to disease risk, it is only one among many genetic and environmental factors that influence disease development.

The study's results are informing the ongoing development of drugs that modulate the complement system, the authors said.

"For example, researchers will need to make sure that drugs that tone down the complement system do not unintentionally increase risk for autoimmune disease," said McCarroll. "Scientists will also need to consider the possibility that such drugs may be differentially helpful in male and female patients."

On a broader level, the work offers a more solid foundation for understanding sex variation in disease than has been available before.

"It's helpful to be able to think about sex-biased disease biology in terms of specific molecules, beyond vague references to 'hormones,'" McCarroll said. "We now realize that the complement system shapes vulnerability for a wide variety of illnesses."

Cell sweeper

In 2016, researchers led by Aswin Sekar, a former McCarroll lab member who is a co-author of the new study, made international headlines when they revealed that specific C4 gene variants underlie the largest common genetic risk factor for developing schizophrenia.

The new work suggests that C4 genes confer both an advantage and disadvantage to carriers, much as the gene variant that causes sickle cell disease also protects people against malaria.

"C4 gene variants come with this yin and yang of heightened and reduced vulnerability in different organ systems," said McCarroll.

The findings, when combined with insights from earlier work, offer insights into what may be happening at the molecular level.

When cells are injured, whether from a sunburn or infection, they leak their contents into the surrounding tissue. Cells from the adaptive immune system, which specialize in recognizing unfamiliar molecules around distressed cells, spot debris from the cell nuclei. If these immune cells mistake the flotsam for an invading pathogen, they may instigate an attack against material that isn't foreign at all--the essence of autoimmunity.

Researchers believe that complement proteins help tag these leaked molecules as trash so they're quickly removed by other cells, before the adaptive immune system pays too much attention to them. In people with lower levels of complement proteins, however, the uncollected debris lingers longer, and adaptive immune cells may become confused into acting as if the debris is itself the cause of problem.

As part of the new study, Kamitaki and colleagues measured complement protein levels in the cerebrospinal fluid of 589 people and blood plasma of 1,844 people. They found that samples from women aged 20 through 50 had significantly fewer complement proteins--including not only C4 but also C3, which activates C4--than samples from men of the same age.

That's the same age range in which lupus, Sjgren's and schizophrenia vulnerabilities differ by sex, Kamitaki said.

The results align with previous observations by other groups that severe early-onset lupus is sometimes associated with a complete lack of complement proteins, that lupus flare-ups can be linked to drops in complement protein levels and that a common gene variant associated with lupus affects the C3 receptor.

"There were all these medical hints," said McCarroll. "Human genetics helps put those hints together."Two flavors

The bulk of the findings arose from analyses of whole genomes from 1,265 people along with single nucleotide polymorphism (SNP) data from 6,700 people with lupus and 11,500 controls.

C4 genes and proteins come in two types, C4A and C4B. The researchers found that having more copies of the C4A gene and higher levels of C4A proteins was associated with greater protection against lupus and Sjgren's, while C4B genes had a significant but more modest effect. On the other hand, C4A was linked with increased risk of schizophrenia, while C4B had no effect on that illness.

In men, common combinations of C4A and C4B produced a 14-fold range of risk for lupus and 31-fold range of risk for Sjgren's, compared to only 6-fold and 15-fold ranges in women, respectively.

The researchers didn't expect the genes' effects to be so strong.

"Large genetic effects tend to come from rare variants, while common gene variants generally have small effects," said McCarroll. "The C4 gene variants are common, yet they are very impactful in lupus and Sjgren's."

Still, complement genes don't tell the full story of lupus, Sjgren's or schizophrenia risk, none of which are caused entirely by genetics.

"The complement system contributes to the sex bias, but it's only one of probably many genetic and environmental contributors," said Kamitaki.

Answers from diversity

Complement genes and another family of immune-related genes, called human leukocyte antigen or HLA genes, are interspersed throughout the same complex stretch of the human genome. HLA variants have been shown to raise risk of developing other autoimmune diseases, including type 1 diabetes, celiac disease and rheumatoid arthritis, and researchers had long believed that something similar was happening with lupus and Sjgren's.

The culprit, however, remained stubbornly hard to pin down, because specific variants in HLA genes and C4 genes always seemed to appear together in the same people.

Kamitaki and colleagues overcame this hurdle by analyzing DNA from a cohort of several thousand African American research participants. The participants' DNA contained many more recombinations between complement and HLA genes, allowing the researchers to finally tease apart the genes' contributions.

"It became quite clear which gene was responsible," said McCarroll. "That was a real gift to science from African American research participants. The question had been unsolved for decades."

The discovery provides further proof that the field of genetics would benefit from diversifying the populations it studies, McCarroll said.

"It will really help for genetics to expand more strongly beyond European ancestries and learn from genetic variation and ancestries all over the world," he said.

C4 variation could contribute to sex-based vulnerabilities in other diseases not yet analyzed, the authors said. It's not yet clear whether C4 pertains to the sex bias seen in COVID-19.

"We don't know the mechanism yet for why men seem to get sicker from COVID-19," said McCarroll. "Complement molecules are potentially important in any immune or inflammatory condition, and in COVID-19, it seems the immune response can be part of a downward spiral in some patients. But we don't know the key details yet."

It also remains to be seen how the differing effects of complement genes apply to people with intersex traits, also known as disorders or differences of sex development, who don't always fit textbook genetic or biological definitions of male and female.

"That is important to understand," said McCarroll.

Reference:Kamitaki et al.Complement genes contribute sex-biased vulnerability in diverse disorders. Nature, 2020; DOI: 10.1038/s41586-020-2277-x.

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American lobsters have occasionally escaped or been released into European waters after being imported for the seafood market.Experts have long feared they could threaten European lobsters by introducing disease or establishing as an invasive species.

Hybridization when a pure species is threatened at a genetic level via interbreeding with a different but related species had been less of a concern because lab studies suggested European and American lobsters were reluctant to mate.

However, when an American lobster female was found bearing eggs in a fjord in Sweden, University of Exeter researchers tested the offspring and found they were clearly distinct from both European and American lobsters.

We had just developed a genetic test for seafood traceability that could separate any American lobsters mislabelled as more expensive European equivalents once theyve been cooked and shell colouration is no longer a useful indicator of the species, said Dr Charlie Ellis, of the University of Exeter.

What we found when we tested these offspring is that they came out exactly in the middle of this separation half American and half European so these lobsters were hybrids.

This has potentially concerning implications for the lobster industry and conservation efforts, and Dr Ellis says further research is required to assess the extent of the threat.

Until recently, it was thought that American and European lobsters would avoid crossbreeding, but this introduced American female has mated with a native European male, probably because she was unable to find an American male, he said.

We now need to check whether any mature adult hybrids are fertile, because if they are then they have the ability to spread these unwanted American genes far and wide across our native lobster stocks.

Working with collaborators from the University of Gothenburg who originally found the hybrid egg clutch, the researchers say their study, published in the journal Scientific Reports, highlights the vital use of genetics to distinguish hybrid lobsters which might look almost identical to a pure strain.

It is particularly concerning that we seem to have found American lobster genes in one of our lobster reserves, said Linda Svanberg of the Gothenburg team.

The better news is we now have this genetic tool to test lobsters or their eggs for hybridisation, added Dr Jamie Stevens, leader of the research which was funded by an EU grant through the Agritech Cornwall scheme, so we can use it track the spread of these alien genes to assess how big a threat this presents to our native lobster species.

The team advise that, for a range of conservation reasons including potential contact with American lobsters, it is important that the general public never release a marketed lobster back into the wild, even our native species.

Dr Tom Jenkins said: Although we appreciate that all animal-lovers have concern for the fate of individual animals, in this case the rescue of one animal might endanger the health of the entire wild population, so once a lobster has entered the seafood supply chain thats where it should stay.ReferenceEllis et al. (2020). Crossing the pond: genetic assignment detects lobster hybridisation. Scientific Reports. DOI: https://doi.org/10.1038/s41598-020-64692-z

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BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc., Inc. (Nasdaq:SGEN) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for TUKYSA (tucatinib) tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine (TDM1).

The application for TUKYSA approval was reviewed by Swissmedic as part of Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies in Canada, Australia and Singapore. On April 17, the FDA approved TUKYSA in the U.S. under the FDAs Real-Time Oncology Review (RTOR) pilot program, four months prior to its action date, and represented the first new drug approved under Project Orbis.

Were grateful to Swissmedic for their collaboration through FDAs Project Orbis in approving this important new medicine in Switzerland, said Jennifer Stephens, Vice President of Regulatory Affairs at Seattle Genetics. We're committed to bringing new targeted therapies to patients, and we are excited about this important first step toward making TUKYSA available to patients in Switzerland.

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.i,ii

The approval is based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The study results were published in The New England Journal of Medicine in December 2019.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including 522,513 in Europe. iii Between 15 and 20 percent of breast cancer cases are HER2-positive.iv Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.v,vi,vii Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.viii,ix,x

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.xi In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Important U.S. Safety Information

Warnings and Precautions

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Use in Specific Populations

For more information, please see the full Prescribing Information for TUKYSA here.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) and PADCEVTM (enfortumab vedotin-ejfv) use the companys industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers. TUKYSATM (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. The company is headquartered in Bothell, Washington, with locations in California, Switzerland and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses including the potential use of TUKYSA in combination with trastuzumab and capecitabine for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine (TDM1) and the potential to bring TUKYSA to patients in Switzerland. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include reimbursement processes, the extent of reimbursement, the possibility that adverse events or safety signals may occur, the possibility that the ultimate utilization and adoption of TUKYSA by prescribing physicians may be limited, including due to impacts related to the COVID-19 pandemic, the possibility of difficulties in supplying and commercializing a new therapeutic agent, and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

i TUKYSA [package insert]. Bothell, WA: Seattle Genetics, Inc.ii Anita Kulukian, Patrice Lee, Janelle Taylor, et al. Preclinical Activity of HER2-Selective Tyrosine Kinase Inhibitor Tucatinib as a Single Agent or in Combination with Trastuzumab or Docetaxel in Solid Tumor ModelsMol Cancer Ther 2020;19:976-987.iii Breast. Globocan 2018. World Health Organization. 2019. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf iv Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.v Loibli S, Gianni L. HER2-positive breast cancer. Lancet. 2017; 389(10087): 2415-29.vi Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.vii Breast Cancer HER2 Status. American Cancer Society website. http://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed March 9, 2020.viii Freedman RA, Gelman RS, Anders CK, et al. TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol. 2019;37:1081-1089.ix Olson EM, Najita JS, Sohl J, et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast. 2013;22:525-531.x Bendell JC, Domchek SM, Burstein HJ, et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003;97:2972-2977.xi TUKYSA [package insert]. Bothell, WA: Seattle Genetics, Inc.

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Statistics show men are more likely to die from Covid-19 and it seems that is due to fundamental physical differences between the sexes.

With twice as many men as women dying from Covid-19, the pandemic is proving that man flu is not a myth and when it comes to immunity women really are the stronger sex.

But having a hyper-vigilant and very aggressive immune system has its downsides too it puts women at greater risk of auto-immune conditions such as multiple sclerosis, rheumatoid arthritis and coeliac disease.

Now, some experts believe these sex-based divides in health and immunity hold the key to conquering not only the coronavirus, but many other health challenges too.

When the first figures emerged from China they showed that although coronavirus infection rates were almost the same for men and women, two-thirds of those dying were men.

Initially, this was put down to the fact that around 62% of Chinese men have smoked, compared to just 3% of women there.

But this theory began to unravel as similar patterns in Covid-19 deaths emerged in Europe and America, where many more women smoke.

Professor Sarah Hawkes, director of the Centre for Gender and Global Health at University College London, says: What Covid-19 is throwing into stark relief is that there are differences, but it is important to understand the difference between sex and gender sex is biological, while gender relates to socially constructed differences.

Gender differences in lifestyle factors such as smoking, diet and alcohol consumption explain some of the health disparities between men and women.

But it is biology, particularly having two X chromosomes, that ensures women really are the fittest when it comes to survival.

Dr Sharon Moalem, an award-winning genetics researcher and best-selling author who has spent decades studying this phenomenon, explains: X chromosomes contain around 1,000 different genes and many are involved in the immune system.

"But the male Y chromosome has only around 70 genes, which are mostly involved in sperm production.

As a result, women not only have two different versions of many immune system genes, these genes also work together and swap genetic information.

Dr Moalem explains: Its like having a tool-box which has two of every tool; two different size screwdrivers, two different hammers, two sizes of wrench.

On top of this, female cells work together, side by side. They have the ability to make a tool and share it with their sister cell, she adds.

Hormones play a part too. Dr Kyle Sue, clinical assistant professor in paediatrics and family medicine at the University of Alberta in Canada, says: Oestrogen tends to be protective, in that it increases the work the immune system is able to do to fight infection, whereas testosterone seems to do the opposite.

And these differences mean that men and women are dealt very different hands when it comes to health.

The XX-factor gives females an advantage before they are even born. Early miscarriage is more common when women have conceived a boy, while pregnancy complications such as pre-eclampsia and placental problems are also more common when women are carrying a boy.

Around 55% of babies born before 32 weeks are boys and this rises to around 60% for very premature babies. Boys who are born prematurely are also more likely to suffer lasting damage such as cerebral palsy and cognitive damage.

One reason for this could be that premature girls have higher levels of catecholamine, a fight-or-flight hormone which primes the body for physical activity.

The most obvious example of female survival superiority is life expectancy. The Office of National Statistics calculates that, on average, a toddler will live to be 79.3 years old if theyre a boy, but 82.9 years if theyre a girl.

Similarly, a 65-year-old man can expect to live for another 18.6 years, but a woman the same age will have another 21 years. Only one in five men makes it to their 90th birthday, compared to one in three women.

Danish researchers who studied death records from seven famines and epidemics (including the Irish potato famine) found women are the life-expectancy champions.

The statistics revealed they lived longer in every case.

Men have a 29% higher risk of developing heart disease and are more likely to have cardiac disease before their 50s. In part this is because of lifestyle: they are more likely to be overweight, drink to excess and smoke. But hormones are a factor too.

Until menopause, women are protected by their higher levels of oestrogen, with studies confirming the hormone reduces oxidative stress, blood pressure and fibrosis, as well as improving the elasticity of blood vessels.

Conversely, testosterone appears to increase cardiac risk by suppressing levels of heart-friendly HDL cholesterol.

Yet despite this, men are more likely to survive their first heart attack.

As heart disease is still seen as a male problem, women often delay seeking help and, when they do, they are 50% more likely to be misdiagnosed.

Women are also less likely to receive bypass surgery, stents and other procedures. Symptoms vary, too. Men usually report crushing chest pain, while women sometimes describe this as tightness or dismiss it as indigestion.

Women are also more likely to experience symptoms such as pain in the arms, nausea and sweating, which are not immediately associated with heart attack.

Having an aggressive immune system puts women at greater risk of auto-immune disorders.

Multiple sclerosis is three times more common in women than men; for every nine women with lupus, only one man is affected; and, under the age of 50, the incidence of rheumatoid arthritis is four to five times higher in women.

But Dr Moalem says women still have an edge. Even though women are more likely to be affected by auto-immune conditions, compared to the men who get them, women do much better.

"For instance, one study found men had an average MS Severity Score of 5.11 while for women the average was just 3.02.

Studies of vaccines, including the MMR, the BCG for tuberculosis and the combined tetanus diphtheria and pertussis shot show women have a much stronger immune response, which gives them better protection.

A large American study of flu jabs found women got two or three times more protection than men from the same dose.

This super-response means women are also more likely to experience side-effects prompting some experts to argue they should have lower doses.

Women are more likely to seek help for pain problems and appear to be more susceptible to specific problems such as migraine and neuropathic pain.

There is also evidence that men and women feel pain in different ways, which could have important implications for pain relief.

Unlimited exercise outdoors is to be allowed, with the previous 'once-a-day' rule scrapped

People will be allowed to sit on parks and beaches, provided they stay two metres away from other people

Boris Johnson said in his speech on Sunday night that people will be able to drive to other destinations from Wednesday, presumably to exercise there, although more detailed plans are likely to follow

From May 13, people will be able to meet one friend or relative from a different household in a public place, provided they stay two metres apart. Gatherings of more than two people remain banned, so people cannot meet both their parents, for example

Golf courses and tennis courts will reopen from May 13, with social distancing relatively easy to achieve, although you can play only with people in your household. Team sports such as football are not likely to be encouraged, as social distancing is difficult and more people than the average household would be required

Angling and water sports are also to be allowed to resume in England from Wednesday. Again, you must be within your own household and two metres from other people

Rather than a change to the rules, the government is now encouraging people to return to work if they cannot do so from home. But they also urge people to drive, walk or cycle to work rather than use public transport, if possible

For instance, the diabetes drug metformin blocks pain from nerve damage but only in men.

Some studies suggest women have a higher pain threshold.

When they have access to self-administered opioids following surgery, men give themselves higher doses even though studies show women need higher doses of morphine to get the same relief.

Men have a higher proportion of muscle, so burn more calories.

On average men need 2,500kcal a day, while women need 2,000. Women are more efficient at storing fat and typically have six to 11% more body fat.

Its an evolutionary safeguard to ensure they could conceive and breastfeed when food was scarce.

Because women have more body fat and less water in their bodies, if a man and woman of the same weight drink the same amount of alcohol, the woman has a higher blood alcohol reading.

Read the rest here:
Deadly coronavirus has proven that women are the stronger sex - Mirror Online

Recommendation and review posted by Bethany Smith

Researchers of a new study have now pinpointed the specific gene responsible for Cape honey bees unique capability for virgin births.

Although this sexless reproductive trait has been known for over a hundred years, it was only through modern genetic tools that researchers were able to discover the responsible gene.

The Cape honey bee is a subspecies of the western honey bee often found along the southern coast of South Africa.

After a 30-year-long search, researchers were able to find the gene, named GB45239, on the bees 11th chromosome. The studys breakthroughs were detailed in the journal Current Biology.

Scientists have been looking for this gene for the last 30 years. Now that we know its on chromosome 11, we have solved a mystery, the studys co-author Benjamin Oldroyd, professor of behavioral genetics at the University of Sydney in Australia, said in a news release.

Researchers said the discovery of this particular gene could propel new insights into the evolution of diverse reproductive strategies among animals.

Sex is a weird way to reproduce and yet it is the most common form of reproduction for animals and plants on the planet, Oldroyd said. Its a major biological mystery why there is so much sex going on and it doesnt make evolutionary sense. Asexuality is a much more efficient way to reproduce, and every now and then we see a species revert to it.

The presence of the GB45239 gene enables Cape honey bee workers to lay eggs that produce only females. The ability to asexually birth daughters is known as thelytokous parthenogenesis.

In such a society where asexual reproduction dominates, males arent necessarily needed. However, having female workers capable of essentially producing duplicates of themselves can cause problems.

Cape workers can become genetically reincarnated as a female queen and that prospect changes everything, Oldroyd said. Instead of being a cooperative society, Cape honey bee colonies are riven with conflict because any worker can be genetically reincarnated as the next queen. When a colony loses its queen the workers fight and compete to be the mother of the next queen.

If scientists can ever find a way to turn on and off the GB45239 gene, the method could be used to combat a variety of asexually reproducing pest species.

If we could control a switch that allows animals to reproduce asexually, that would have important applications in agriculture, biotechnology and many other fields, Oldroyd said.

Ethen Kim Lieser is a Tech Editor who has held posts at Google, The Korea Herald, Lincoln Journal Star, AsianWeek and Arirang TV.

Image: Reuters

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Researchers Discover Gene Responsible for Honey Bee Virgin Births - The National Interest

Recommendation and review posted by Bethany Smith

When a woman named Shanawdithit died from tuberculosis in Newfoundland nearly 200 years ago, it was widely believed that her death marked a tragic end to her peoples existence.

For centuries, the Beothuk had thrived along the rocky shores of the island, taking on a near-mythical status as descendants of the first people encountered by Norse explorers in what is now Canada. But their population was devastated by decades of starvation and diseases, and when she died in 1829, Shanawdithit was believed to be the last of her line.

New research from Memorial University, however, has found Beothuk DNA probably still exists in people alive today a discovery that would rewrite the history of the Newfoundlands early inhabitants, even as it confirms the accuracy of local First Nations oral tradition.

Weve got good evidence that we have genetic continuity from the Beothic into modern persons, said biologist Dr Steve Carr.

But while the finding would trigger a rethink for historians, the notion is not surprising to local Indigenous groups.

Mikmaq oral history has long asserted a shared ancestry with the original inhabitants of Newfoundland, and local First Nations have worked closely with Carr to help lend genetic evidence to their own traditions.

There were always connections or friendly relations going back more than 200 years ago and when you mingle that way, periodically, things would happen, said Chief Misel Joe of the Miawpukek Mikamawey Mawiomi, a Mikmaq First Nation in Newfoundland.

Historians believe the Beothuk are descended from a group that braved the ocean to cross from Labrador to Newfoundland thousands of years ago and whose distinct culture emerged around 1500 CE. At one point, as many as 2,000 Beothuk lived in communities scattered around Newfoundland.

For generations, they largely resisted and avoided relations with European settlers; the few interactions between the two were defined by violent encounters.

Early European settlements on the coast cut off Beothuk access to critical salmon and seals forcing them to move further inland where they sustained themselves on caribou before finally succumbing to starvation and disease.

But Carrs research suggests it was only a cultural extinction; their genetic legacy lives on.

In his study, Carr used DNA samples from Shanawdithits aunt and uncle Demasduit and Nonosbawsut whose skulls were sent to the University of Edinburgh in the 1850s. After a long campaign by Chief Joes community, the remains were repatriated to Newfoundland from National Museums Scotland in March.

After running samples through a genetics database, Carr was able to find his smoking gun a man in Tennessee who was genetically similar to Nonosbawsut, but had no known Indigenous ancestry.

With only a small amount of data to work with, Carr hopes more samples will further demonstrate a connection.

Its easy to obtain the DNA sequence from somebody and you can count the number of similarities. Thats a very easy thing to do. But to reconstruct the patterns of a relationship is a very challenging problem, said Carr, adding that further research into the known movement and connections between the Beothuk and Mimaq was still required.

The findings also illustrate the way in which genetic uniqueness in this case the distinct sequence of Beothuk mitochondrial genomes can persist intact for generations. While humans share an immense amount of DNA that traces back millennia, said Carr, the intent of his research lay in teasing out the subtle and distinguishing differences between known groups.

For years, academia has ignored the oral histories of Indigenous peoples, said Chief Joe.

Academics are hard people to convince. They often have this mindset that this the way it was no matter what information we give them to the contrary, he said.

He described a frustrating experience in a land claims court, where the adjudicator suggested the Mikmaq first arrived in Newfoundland in the 1700s.

But we have an oral history of British sailors meeting our people and asking for directions. We drew them a map on birch bark. If this is the first time we had ever been on the land, how could we draw a map? said Joe.

Its convenient for government, for everyone, to ignore people who had no written history

The community is excited to keep working with Carr on further testing, said Joe, to further strengthen the evidence of shared ancestry.

This is a big thing for us, he said. But it all comes from something we already knew.

This article was amended on 11 May 2020. An earlier version incorrectly said that the skulls of Demasduit and Nonosbawsut were taken to the Royal Museum in Scotland in 1828.

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Canada: DNA discovery lends weight to First Nations ancestral story - The Guardian

Recommendation and review posted by Bethany Smith

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada) today announced LYNPARZA (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

The approval by the US Food and Drug Administration (FDA) was based on a biomarker subgroup analysis from the Phase III PAOLA-1 trial which showed LYNPARZA in combination with bevacizumab reduced the risk of disease progression or death by 67% (equal to a hazard ratio of 0.33). The addition of LYNPARZA also improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

Approximately one in two women with advanced ovarian cancer has an HRD-positive tumor. For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.

Isabelle Ray-Coquard, principal investigator of the PAOLA-1 trial and medical oncologist, Centre Lon Brard and President of the GINECO group, said: Ovarian cancer is a devastating disease. The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful. The combination of LYNPARZA and bevacizumab now provides women with HRD-positive advanced ovarian cancer with a new standard of care and I look forward to seeing this translate into clinical practice.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: This approval represents another milestone for LYNPARZA in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease. These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said: Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer. Todays approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from LYNPARZA in combination with bevacizumab as a 1st-line maintenance treatment.

Fatal adverse reactions occurred in 1 patient due to concurrent pneumonia and aplastic anemia. Serious adverse reactions occurred in 31% of patients who received LYNPARZA/bevacizumab. Serious adverse reactions in >5% of patients included hypertension (19%) and anemia (17%).

The most common adverse reactions (Grades 1-4) occurring in 10% of patients treated with LYNPARZA/bevacizumab and at 5% frequency compared to placebo/bevacizumab were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

The full results from the Phase III PAOLA-1 trial can be found inThe New England Journal of Medicine.

Financial considerationsFollowing this approval for LYNPARZA in the US, AstraZeneca will receive from Merck $100m in Collaboration Revenue, anticipated to be booked by the Company during the second quarter of 2020.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

FemalesAdvise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

MalesAdvise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONSFirst-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONSFirst-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in 10% of patients treated with LYNPARZA/bevacizumab compared to a 5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%) and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%) and decrease in platelets (35%).

ADVERSE REACTIONSMaintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%) and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONSAdvanced gBRCAm Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSgBRCAm, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONSFirst-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA in combination with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors. If a strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid concomitant use of strong or moderate CYP3A inducers when using LYNPARZA. If a moderate inducer cannot be avoided, there is a potential for decreased efficacy of LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr 30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian CancerFor the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced gBRCAm Ovarian CancerFor the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm, HER2-Negative Metastatic Breast CancerFor the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance gBRCAm Metastatic Pancreatic CancerFor the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

NOTES TO EDITORS

About Ovarian CancerApproximately 22,000 women in the United States are diagnosed with ovarian cancer (including ovarian, fallopian tube and primary peritoneal cancers) each year. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. The risk of developing ovarian cancer is increased in women with specific inherited genetic abnormalities, including BRCA1/2 mutations.

Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%. Approximately 50% of ovarian cancers are HRD-positive, including BRCA1/2 mutation. Some 22% of ovarian cancers have a BRCA1/2 mutation.

About PAOLA-1PAOLA-1 is a double-blind, Phase III trial testing the efficacy and safety of LYNPARZA (300 mg twice daily) in combination with bevacizumab vs. bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and Merck announced in August 2019 that the trial met its primary endpoint of PFS.

Simultaneously, the Myriad Genetics myChoice CDx test has been approved in the US as a companion diagnostic for LYNPARZA in this new indication.

About Homologous Recombination DeficiencyHRD, which defines a sub-group of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including LYNPARZA.

About LYNPARZALYNPARZA (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR pathway.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types. LYNPARZA is being tested in a range of DDR-deficient tumor types and is the foundation of AstraZenecas industry-leading portfolio of compounds targeting DDR mechanisms in cancer cells.

About the AstraZeneca and Merck Strategic Oncology CollaborationIn July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products, including LYNPARZA, the worlds first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.

About AstraZeneca in OncologyAstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients lives and the Companys future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZenecaAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

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LYNPARZA (Olaparib) Approved in US as 1st-line Maintenance Treatment With bevacizumab For HRD-Positive Advanced Ovarian Cancer - Business Wire

Recommendation and review posted by Bethany Smith

A decade ago, scientists won the nobel prize for connecting the dots between telomeres and aging. Telomeres are the protective caps on the ends of the strands of DNA called chromosomes. Telomeres shorten every time a cell divides. When they become very short, they trigger cell crisis and cell death.

Since this discovery was made, researchers have found new insights into telomeres and their connection to wrinkled skin, as well as how their length might be extended.

Scientists have uncovered new information on telomeres that could help combat the effects of inflammation and aging. Researchers from the University of Pittsburg recently discovered how oxidative stress plays a critical in the link between telomeres and cancer. I dont want to blind you with science (telomeres are a complex area), but every breakthrough into telomeres will ultimately equal a breakthrough in understanding how we age and how we can keep cells including our skin cells healthy.

Telomeres are composed of repeated sequences of DNA. The results from this study suggest that the mechanism by which oxidative stress accelerates telomere shortening is by damaging the DNA precursor molecules, not the telomere itself. This will have a big impact on appreciating how to manage oxidative stress to prevent aging and diseases such as cancer.

At Stanford University School of Medicine, scientists claim they can now lengthen teleomeres. Skin cells with telomeres lengthened by the procedure were able to divide up to 40 more times than untreated cells (source).

However, longer teleomeres is not necessarily associated with a longer life (source). Indeed, those naysayers say that good diet and an exercise regimen will do that. Yet, it does seem that preventing further shortening of the telomeres could be beneficial, especially for aging skin. Telomeres are likened to the tips of shoelaces that stop them unraveling and so you really want to be thinking about how to stabilize your telomeres. Happily, advances in skin care can help you out. There are three approaches to consider: special ingredients that target telomeres, ingredients that prevent oxidative damage (known, of course, as antioxidants) and stem cells.

Target your telomeres

One very interesting ingredient is called astragalus, and although it is rare, we do have a couple of Truth In Aging finds with it. But first, what is it and how does it work? In 2008, a UCLA AIDS Institute study found that a chemical they called TAT2 from the astragalus root, which is frequently used in Chinese herbal therapy, can prevent or slow the progressive shortening of telomeres. It can be found in Prana Reishi Mushroom Shield ($42 in the shop) and ExPrtise Effective Anti-Aging Face Serum ($120 in the shop).

Another ingredient to look for is treprenone, also marketed under the name of Renovage. Its promise is to stabilize telomeres, so at the very least they won't shorten. Maintaining telomere length extends the Hayflick Limit (the rate at which cells turn over before conking out completely) by one third. Youll find treprenone (Renovage) in Your Best Face Correct ($150 in the shop) Your Best Face Boost ($65 in the shop.

Amp up with antioxidants

The research is clear: Preventing oxidative damage is the job of an antioxidant. Free radicals are charged chemical particles of oxygen that enter into destructive chemical bonds with organic substances such as proteins, as explained by Gerald Imber, MD. Antioxidants limit the production of free radicals and therefore help prevent oxidative stress. There are many sources in plants, and vitamins are also antioxidants.

There are 33 antioxidants in Skin 2 Skin Aging Intervention Cream ($73 in the shop), including the universal antioxidant alpha lipoic acid. The powerful antioxidants in Your Best Face Rescue ($145 in the shop) include spin trap, an advanced form of vitamin C and EGCG. Bee venom has some 18 active compounds include antioxidants, peptides with powerful anti-inflammatory actions, and enzymes. It is the key ingredient in LaCrme Beaut Luxurious Bee Venom Rich Face Treatment Cream ($202 in the shop).

Look for plant stem cells

Plant stem cells never age. British scientists found that plant stem cells were much more sensitive to DNA damage than other cells. Once they sense damage, they trigger death of these cells before it spreads and causes more. In addition, they have the ability to stimulate cell renewal and replace specific cells in need of repair.

Ao Skincare Raw Nourish AM Treatment ($65 in the shop) has the powerful antioxidant astaxanthin and plant stem cells.

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New Study Suggests the Consequences of Oxidative Stress on Telomeres - Truth In Aging

Recommendation and review posted by Bethany Smith

Healthcare Business

Chris Lange

Aytu BioScience Inc. (NASDAQ: AYTU) has been a stock market darling since it broke onto the COVID-19 testing scene. As a result, the stock has absolutely exploded this year. Although many were concerned at the onset of the year about Nasdaq compliance, the stock price quickly quieted these concerns when COVID-19 hit the scene.

Aytu BioScience stock traded as low as $0.34 a share in February before it came out with a test to help fight the pandemic. Since then, the shares have reached as high as $2.99, but they have normalized and found a trading range between $1.25 and $1.65.

Testing for the coronavirus has become a lucrative field. Other companies specifically dealing with this include Quest Diagnostics Inc. (NYSE: DGX), Co-Diagnostics Inc. (NASDAQ: CODX) and Becton, Dickinson and Co. (NYSE: BDX). Their stocks have seen solid gains since they entered the coronavirus test business as well.

Aytu BioScience is a specialty pharmaceutical company. It focuses on the development and commercialization of novel products in the fields of hypogonadism (low testosterone), cough and upper respiratory symptoms, insomnia, and male infertility.

What has set this company apart from the rest is that it has secured an exclusive distribution agreement for the right to commercialize a rapid COVID-19 test. The company said that the test has been licensed from L.B. Resources in Hong Kong. It licensed North American rights from a product developer named Zhejiang Orient Gene Biotech.

The test is intended for professional use, at point of care. What stands out here is that the test is said to deliver clinical results in two to 10 minutes, wherever it is administered.

Late in April, the company announced that it has partnered with Sterling Medical Devices to finalize the development of the Healight platform technology. Basically, this tech is a novel endotracheal catheter that acts as a potential treatment for the coronavirus.

Management believes the Healight platform technology has the potential to affect outcomes positively for critically ill patients infected with coronavirus and other infections. Aytu, with support of the team at Cedars-Sinai, is working with the U.S. Food and Drug Administration (FDA). The aim is to determine an expedited regulatory process with the potential to enable near-term use of the technology initially as a coronavirus intervention for critically ill intubated patients.

Aytu BioScience held its 2020 annual meeting in late April. A few key developments there will have an impact on the direction of the company. To start, a few new directors will get their turn on the board.

In the meeting, stockholders elected Joshua Disbrow, Steven Boyd, Gary Cantrell, Carl Dockery, John Donofrio Jr., Michael Macaluso and Ketan Mehta to the companys board of directors for one-year terms.

Separately, stockholders approved an advisory vote on executive compensation and ratified the appointment of Plante & Moran as the independent auditor for the company for the 2020 year. Stockholders also approved the board of directors to authorize a reverse split of the companys common stock.

However, the board did not elect to proceed with a reverse stock split at that time. This decision is the result of Aytu regaining compliance with Nasdaq listing requirements, including having a $1.00 closing bid price for the companys common stock. Additionally, the board noted that effecting a reverse split would not be in the best interest of shareholders at the time.

Check out the companys 8-K from this meeting on the U.S. Securities and Exchange Commission website.

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COVID-19 Testing Continues to Lift Aytu BioScience Stock - 24/7 Wall St.

Recommendation and review posted by Bethany Smith

Advancing your induced pluripotent stem cells or human embryonic stem cell therapy research to clinical applications requires careful material selection because the quality of starting materials significantly impact the properties of your final stem cell therapy product. Gibco CTS products have been developed to ease the transition from stem cell therapy research to clinical applications by providing high quality GMP manufactured, commercial scale ancillary materials with a high degree of qualification, traceability and regulatory documentation. In an effort to help you maximize the potential of your stem cell research and therapy, and simplify the transition to clinic-ready processes, we offer an extensive selection of research use stem cell research products with complementary CTS formulations. Our CTS products are used in commercially approved cell therapies as well as over 100 clinical trials and are backed by our professional regulatory support and over 30 years of GMP manufacturing experience.

Induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs) , sometimes collectively referred to as pluripotent stem cells (PSCs), are cells that have the ability to renew themselves indefinitely and differentiate into almost any cell type when exposed to the right microenvironment. These unique properties enable the application of induced pluripotent stem cells and embryonic stem cells in disease modeling, drug discovery, drug toxicity testing, and cell therapy. Strikingly, most embryonic stem cell and induced pluripotent stem cell applications have the potential to improve human health, none more directly so than ESC or iPSC therapy. The most intuitive approach for ES or iPS cell therapy is to transplant PSC-derived cells for the direct replacement of damaged or degenerated cells or tissue. However, there are many other approaches to ES or iPS stem cell therapy such as transplanting PSC-derived cells that then release signals triggering endogenous repair mechanisms.

At Thermo Fisher Scientific, we support the development of your human embryonic stem cell therapy or induced pluripotent stem cell therapy from the earliest stages of research and all the way to the clinic. We offer high-quality products across the iPS cell therapy workflow from reprogramming to differentiation. Most Gibco media and supplements for culture and differentiation are manufactured under GMP conditions at sites that use methods and controls that conform to current Good Manufacturing Practices (cGMP) for medical devices. These manufacturing sites are ISO 13485 and ISO 9001certified, and the rigorous practices we adhere to at these sites help ensure the consistency, reliability, and high quality of a wide variety of iPSC therapy workflow reagents.

To further help you maximize the potential of your research and streamline your transition to the clinic, we offer Gibco Cell Therapy Systems (CTS) equivalents for many of our research-use products. In addition to GMP manufacturing, Gibco CTS products undergo quality control testing and are accompanied by appropriate documentation so you can transition your cell therapy to the clinic with confidence.

*Adherence to supplier related responsibilities of USP<1043>

First off-the-shelf reprogramming system manufactured in accordance with GMP requirements. CTS CytoTune 2.1 kit offers high-efficiency Sendai delivery of reprogramming factors.

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Efficient reprogramming from adult human dermal fibroblasts, T cells, and CD34+ cells. These data demonstrate that the CytoTune-iPS 2.1 kit can be used to successfully reprogram human dermal fibroblasts (HDFa), T cells, and CD34+ cells.

Gibco CTS Essential 6 Medium is a xeno-free, feeder-free, cGMP-manufactured medium which supports the spontaneous or directed differentiation of human pluripotent stem cells (PSCs) and the reprogramming of somatic cells.

Based on the widely cited Gibco Essential 8 Medium, Gibco CTS Essential 8 Medium is the first globally available human- and animal originfree culture medium for human pluripotent stem cells (hPSCs) and is designed to meet international regulatory requirements for cell therapy.

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Using Applied Biosystems TaqMan hPSC Scorecard Panel analysis, Gibco CTS Essential 8 Medium and research-use-only Essential 8 Medium were shown to support comparable expression of PSC markers and lineage markers in undifferentiated PSCs and PSC-derived embryoid bodies.

CTS Vitronectin (VTN-N) Recombinant Human Protein is a defined matrix for feeder-free culture of iPSCs. Designed in the laboratory of James Thomson, this recombinant protein is intended for use with the CTS Essential 8 culture system.

CTS RevitaCell Supplement (100X) is an animal-origin-free, chemically defined supplement used with PSCs for post-thaw recovery or in combination with CTS Essential 8 Medium for single cell passaging. To minimize both the loss of cell viability and differentiation of PSCs, use the CTS PSC Cryopreservation Kit.

CTS Versene is a gentle non-enzymatic cell dissociation reagent for use in routine clump passaging of PSCs while maintaining viability over multiple passages.

For the cryopreservation and recovery of PSCs, the CTS PSC Cryopreservation Medium and CTS RevitaCell Supplement minimize the loss of cell viability and maximize post-thaw recovery when used in combination. Both reagents are included in the CTS PSC Cryopreservation Kit.

The CTS PSC Cryopreservation Medium is a xeno-free solution for the cryopreservation of pluripotent stem cells (PSCs). Both CTS PSC Cryopreservation Medium and CTS RevitaCell supplement are included in the CTS PSC Cryopreservation Kit that helps minimize loss of cell viability and maximize post-thaw recovery.

CTS KnockOut SR XenoFree Medium is a defined, xeno-free serum replacement based on the traditional Gibco KnockOut Serum Replacement, which has been cited in more than 2,000 publications and trusted for over 20 years.

Maintenance of pluripotency using CTS KNOCKOUT SR XenoFree Medium. Following 10 passages in either KSR (left lane) or KSR XenoFree CTS (right lane) on HFF attached with CELLstart substrate, BG01v gene expression was examined (top). Gene expression of embryoid bodies generated from the same P10 BG01v/HFF cultures (bottom).

Your choice of chemically defined human- and animal origin-free basal media for pluripotent stem cell culture. Based on traditional DMEM and DMEM/F12 formulations, these basal media are:

We offer full customization options to help meet your unique specifications for any project. Flexibility is yours in creating your own Gibco custom cell culture medium

Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.

See the article here:
Induced Pluripotent Stem Cell (iPSC) Media and Reagents ...

Recommendation and review posted by Bethany Smith