Abstract and Introduction Abstract

In recent years, testosterone replacement therapy (TRT) has received significant media attention, and the rate of testosterone use has increased notably. A reported association between testosterone use and increased occurrence of myocardial infarction and stroke prompted the FDA to issue a safety bulletin in 2014. Clinical hypogonadism is the only FDA-approved indication for TRT in men; it is not approved to treat age-related low testosterone. Although it is not indicated, TRT is often recommended to improve sexual function, bone density, body composition, muscle strength, mood, behavior, and cognition. The literature on the effectiveness of TRT for various conditions is largely mixed; therefore, current data on appropriate and potentially inappropriate use are important for pharmacists to keep abreast of and discuss with patients.

Recently, the use of testosterone replacement therapy (TRT) has received a lot of media attention. Although its use is growing, there is much debate regarding TRT's risks and benefits.[1] From 2008 to 2012 in the United States, spending on TRT increased from $1 billion to $2 billion, and from 2003 to 2013 there was a fourfold increase in the rate of TRT in men aged 18 to 45 years.[2] In 2013 and early 2014, two studies reported an association between TRT and increased occurrence of myocardial infarction and stroke, prompting the FDA to issue a safety bulletin on January 31, 2014.[3] This article will discuss appropriate TRT use, available formulations and cost, side effects, trends, and the pharmacist's role in patient education, including counseling points.

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Testosterone Replacement Therapy: Controversy and Trends - Medscape

Recommendation and review posted by Bethany Smith

Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.

Here are the key catalytic event a biotech investor should keep a tab on in the unfolding week.

The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)'s NDA for Tlando, or LPCN 1021 to treat hypogonadism in adult males. The PDUFA date is set for Saturday, Nov. 9.

Alkermes Plc (NASDAQ: ALKS) Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in solid tumors.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) Phase 1 data for CDX-1140 in solid tumors (Friday, Nov. 8).

Pieris Pharmaceuticals Inc (NASDAQ: PIRS) Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

CELYAD SA/ADR (NASDAQ: CYAD) Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer (Friday, Nov. 8) and Phase 1 data for CYAD-101 in colorectal cancer (Saturday, Nov. 9).

Heat Biologics Inc (NASDAQ: HTBX) Phase 2 data for HS-110 and Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo in non-small cell lung cancer (Friday).

Oncolytics Biotech, Inc. (NASDAQ: ONCY) - interim Phase 1b data for Pelareorep and Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq in breast cancer (Friday).

Nektar Therapeutics (NASDAQ: NKTR) updated Phase 1/2 data for NKTR-214 + Opdivo in multiple cancers (urothelial carcinoma, melanoma, renal cell carcinoma, and non-small cell lung cancer) (Saturday).

Mirati Therapeutics Inc (NASDAQ: MRTX) initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

Allena Pharmaceuticals Inc (NASDAQ: ALNA) Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria (Friday).

See Also: BTIG: Crispr Could Be A Takeover Target For Vertex

The earnings list is not comprehensive

Monday

Tuesday

Wednesday

Thursday

Friday

Galera Therapeutics has filed to offer 5 million shares in an IPO, with an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "GRTX."

89bio, a biotech company focusing on therapies for NASH and other metabolic disorders, is planning a 4.375-million IPO at an estimated price range of $15-17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ETNB."

Gene testing company Centogene is proposing to offer 4 million shares in an IPO, which are to be priced between $14 and $16. The company has applied to list the shares on the Nasdaq under the ticker symbol "CNTG."

CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, has filed for a 2.125-million share IPO. The shares, which are likely to be priced in the range of $4-$5, are to be listed on the Nasdaq under the ticker symbol "CNSP."

Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, is set to offer 4 million shares in an IPO, with each share to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol "TELA."

BioNTech SE ADR (NASDAQ: BNTX)Vir Biotechnology Inc (NASDAQ: VIR)

2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight - Benzinga

Recommendation and review posted by Bethany Smith

ENGLEWOOD, CO / ACCESSWIRE / November 7, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced that the company will present its operational results for the quarter ended September 30, 2019 on November 14, 2019, at 4:30 p.m. ET. The company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information:

Interested participants and investors may access the conference call by dialing either:

1- 844-602-0380 (toll-free)

1- 862-298-0970 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) and using the replay access code 56773.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu is the exclusive U.S. licensee with commercial rights to Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Additionally, Aytu is developing MiOXSYS, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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Aytu BioScience to Report Fiscal Q1 FY 2020 Results and Business Update - Yahoo Finance

Recommendation and review posted by Bethany Smith

Your vision may change as you get older, but it can also change much sooner than you think if you are not careful.

These are some ways to keep your eyes seeing longer.

From looking at TV to looking outside at nature, your eyes focus on 50 different objects per second. But your eyes aren't perfect; they can run into problems, for example, if you stare at your phone too long.

"That's high-energy visible light, but it's harmful, and that's what causes the digital eye strain," Florida ophthalmologist Dr. Alan Mendelsohn said.

Experts say if you feel weary, just take a break. If you are not careful, this could lead to red eyes and possibly pink eye.

"Vision becomes blurry, eyes become fatigued, sometimes red. It's very frequent to start getting headaches," Mendelsohn said.

To reduce the irritation, take a cool or warm towel to your eyes.

But not every cause is so easily fixed. Lazy eye, which causes vision to be weaker, requires surgery, and so does uveitis, which causes inflammation in the middle layer of your eye and cataracts.

"It's almost like having a stone inside your eye, and breaking that up sometimes requires a lot of energy. That energy is not good to the eye," said Dr. Sean Lanchulev, a New York eye and ear doctor.

If you don't take care of cataracts, that could lead to night blindness.

Finally, watch out for the sun. Not protecting your eyes could lead to excess tearing or floaters, which could be a sign of retinal detachment. So, wear those sunglasses for style and protection.

Contact wearers, beware! Do not wet them in your mouth, as it could lead to infection, and be sure that they fit properly to protect your eyes from being scratched.

RESEARCH SUMMARYPROTECTING YOUR SIGHT REPORT #2690

BACKGROUND: Around 1.3 billion people around the world live with some form of distance or near vision impairment. Regarding distance vision, 188.5 million have mild vision impairment, 217 million have moderate to severe vision impairment, and 36 million people are blind. When it comes to near vision, 826 million people live with a near vision impairment. Having good ocular health means that vision is at least 20/20 or better with or without correction, and the eyes are disease-free. Ophthalmologists can provide total eye care, from examinations and vision correction to the diagnosis and treatment of disease through medication and surgery. By getting regular exams and discussing family history, your doctor is better able to anticipate, prevent, and treat eye disease. Not wearing your prescribed eyeglasses or contacts will not cause disease of the eye, but it can cause discomfort by eyestrain, headaches, or possibly injury brought on by the lack of safe vision. Constant exposure to ultraviolet rays can result in photochemical eye damage and wearing safety glasses and protective goggles while playing sports or working with hazardous or airborne materials lowers your risk for eye injury, damage to vision, and complete loss of sight. (Source: https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment and https://my.clevelandclinic.org/health/articles/8560-ocular-health)

MOST COMMON EYE DISEASES AND TREATMENTS: Macular degeneration is the damage to the central portion of retina, known as the macula. There are no definite signs and symptoms in earlier stages of macular degeneration other than gradual or sudden change in the quality of your vision followed by appearance of straight lines as distorted. There are some prescription medications helpful with macular degeneration in preventing the growth of abnormal blood vessels within the eye. Cataracts are another common eye problem. Symptoms can include blurred, clouded or dim vision; problem seeing at night; and problem seeing through light and glare. Surgery is the only effective treatment, which involves removal and replacement of cloudy lens with an artificial one. Glaucoma is an eye condition where the eye's optic nerve is damaged, getting worse over time. It results in pressure buildup within the fluid in your eye, which can potentially damage the optic nerve responsible for transmitting images to your brain. From eye drops to pills, traditional surgery and laser surgery, or even a combination of these methods, an experienced eye doctor would recommend any treatment if it is focused on preventing vision loss. (Source: https://irisvision.com/most-common-eye-problems-signs-symptoms-and-treatment/)

GENE THERAPY FOR EYES: Scientists researching a form of inherited blindness in children called Leber's congenital amaurosis recently had success in a clinical trial that improved the vision of children. The trial was preceded by 30 years of research by Jean Bennett and her husband, Al Maguire, at the Scheie Eye Institute of the University of Pennsylvania, as well as other scientists at Penn and around the world. The gene, which is called RPE65, is injected into the eye, under the retina, in an operating room procedure. It enters retinal cells because it is packaged into a safe virus called adeno-associated virus (AAV). Neither the naturally occurring AAV nor the genetically modified version designed to carry the RPE65 gene into people causes disease. The genetically modified AAV was able to significantly restore vision in blind children, enabling them to complete tasks such as walking through a maze without bumping into soft objects, or catching a ball. The retinal RPE65 gene therapy is a breakthrough that will pave the way for gene therapies treating several other retinal diseases, including age-related macular degeneration (AMD), retinitis pigmentosa, and choroideremia.

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Protecting your sight: What you need to know - WNDU-TV

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Maria Todd would probably prefer that I write this story about well, anyone else but her. When I first interviewed her and began with the warm-up question of how long shes been researching and teaching biology at Southwestern (the answer is 18 years, since 2001), she very quickly shifted focus to talking about a remarkable undergraduate she taught years ago who is now an oncologist. When she publishes her research, she gives credit to every person who sends her samples because naming them as contributors will, she says, help them get grantsand if theyre getting grants, that helps the whole community. If youre lucky enough to be one of her students or have a cup of tea with her, youll notice that she exhibits a generosity of spirit and that quintessential self-deprecatory Anglo-Irish sensibility that immediately draws you in.

And if you didnt know any better, youd almost never guess that this utterly unpretentious, quietly funny, and genuinely delightful individual is an expert in molecular biology and genetics who has made significant contributions to the progress of cancer research.

Dr. Maria ToddThe evolution of a scientist

A born biologist whose first memory is of crawling down the garden path behind her London home and being fascinated by ants and stones and leaves, Todd recalls that her early love of science was the product of curiosity and exploration. I remember as a child just staring at leaves and their veins, and my parents would allow me to dissect plants and flowers with kitchen knives, she says. Id look at a beautiful flower, and then I would dissect it to see what was inside. I had to understand how it worked. Im always appreciative of the beauty of nature, but I want to understand the mechanisms behind it.

With the loving encouragement of her parents, Todd analyzed specimens she discovered in London parks and by the seaside, experimented with chemistry sets at home, and tinkered with gadgets her father would bring home from his work as an electronics engineer. She eventually enrolled as an undergraduate at the University of Sussex, where Todd originally hoped to specialize in conservation biology and ecology, following in the footsteps of her hero, Jane Goodall. But a first-year course on molecular and population genetics captured her imagination. I knew then, at 19 years old, that this would revolutionize medicine, and I was completely seduced, she recounts. It changed my life. So she traded romantic visions of a future examining ferns on the moors of England for a more fitting career at the lab bench studying genetic engineering.

Her studies would continue during a Ph.D. program at Cambridge University, where she lived for one year in the former home of the father of evolutionary thinking. It was amazing to walk into the drawing room and think, This is where Charles Darwin sat and read his newspapers and worked on the Origin of Species, and here am I, a little 20-something geneticist, sitting in the same window seat perhaps where he sat and looking out onto the grounds, she recalls. It was a very magical experience. She then adds with a laugh, The rest of the accommodation was not magical and is best forgotten. Todd admits that she did sometimes feel rather intimidated while at Cambridge, where she was one of only two women in her medical research cohort and worked in a lab flanked by a pair of Nobel Prize winners. Like so many graduate students, she was periodically afflicted with impostor syndrome, wondering whether her admission to the program had been some sort of mistake or even a cruel sociological experiment. But once she began to build a community among other women scientists at the university, her confidence grew, and she knew that she and her colleagues did, in fact, belong.

The importance of good questions

Todd shares stories like these with her Southwestern students, bringing profound empathy to her teaching and mentorship of students. Most of my time is spent reassuring students, reminding them that theyre here for a reason, that they are good enough to be here, that they will excel here, that they are making a really valuable contribution to this community of learning, that we want them here, [and] that were learning from them just as they learn from us, she says. I always encourage students to ask questions and to share their ideas because their ideas might be the next great breakthrough. Its this approach to teaching that has understandably earned Todd multiple honors throughout her years at SU, including theExemplary Teaching Award from the Board of Higher Education and Ministry of the United Methodist Church and the Southwestern University Teaching Award.

As one might expect of the limelight-shy biology professor, Todd prefers that the camera's focus remain on her students, like Shi Solis '20 , rather than on her.Shi Solis 20, one of Todds current research assistants, can attest that her mentor has been a delight to work with. A methods course with Todd inspired the English major to add biology as her second major, but even more than her coursework, Solis feels that the productive failure of trial and error that characterizes any laboratory setting has really expanded her understanding of biology. Working with Dr. Todd is the best. Shes an angel, Solis remarks. I feel like we came in, and we werent super prepared in what it was like to do research, but shes the best teacher. Even if we dont know anything, she makes us feel that this is a learning environmentthat every minute in the lab is a learning experience.

Biology major Anthony Seek 20 agrees that the lab experience, even with all its mental hurdles, has been pretty awesome because its pushed him to consider not just the what but also the why of cell biology: I wanted to do this before I came here, and Im really excited I got the opportunity to do this and work with Dr. Todd. Shes amazing. I sat in on one of her classes before I came [to SU], and it was great. Shes the best person to work with.

Todds appreciation for Solis and Seek is conspicuous as she praises them for being such independent thinkers and doers. She says that working with undergraduates is fabulous and lovely because they bring youthful enthusiasm; they bring their curiosity. And something that I think is very special about undergraduates is that they ask questions that are quite basic, fundamental questions, and these are the best questions to ask in science. She explains that as more advanced researchers delve deeper into their fields, they tend to think of more sophisticated, complicated questions. But the best science is when we ask very straightforward questions, and students will do that, kind of pulling me up a little [because] maybe I had made an assumption about something . They also ask questions about mechanisms and cellular processes that really keep me on my toes in terms of staying up to date with the literature. And unlike how labs are often portrayed on television, Todd observes that laboratories are communities; no scientist works in isolation. Were highly collaborative, and were highly social creatures . Our students bring life and heart to the lab.

A common but understudied cancer

When students like Seek and Solis apply to work in Todds lab at Southwestern, they have to be highly conscientious, precise, and detail oriented. Thats because theyll be working with complex instruments and techniques that are difficult to learn and require weeks to months of practice to master, or, conversely, theyll be focusing for long periods on techniques that arent necessarily difficult but can be quite tedious.

Those students must possess physical and mental fortitudenot to mention a sense of respect for their materialsbecause they are working with cancer cells that are older than they are.

Todd and her students are studying uterine cancer, which, according to the nonprofit World Cancer Research Fund International, is the sixth most commonly occurring cancer in women (only breast, colorectal, lung, cervical, and thyroid cancers have higher incidences worldwide). More than 382,000 new cases of uterine cancer were reported in 2018, and approximately 76,000 patients die from the disease each year.

Elliot Hershbergn 18 and Sid Pradeep 17 worked alongside Professor Maria Todd in summer 2016.

Although uterine cancer is the most common gynecological cancer in the U.S., it is, paradoxically, also the least studied compared with ovarian, cervical, vaginal, and vulvar malignancieswhich is just one reason Todd and her longtime collaborator, fellow Southwestern Professor of Biology and Garey Chair in Biology Maria Cuevas, switched their research efforts from breast to uterine cancer several years ago while putting together an application for a National Institutes of Health grant. Todd believes its one of those cancers thats often overlooked by researchers because uterine cancer doesnt have the same advocacy groups that breast and ovarian cancers have enjoyed for the past 15 years. Those cancers have benefited from better research funding and more media coverage, likely because uterine cancer occurs less frequently than breast cancer does (one in 25 women versus one in seven, respectively) and is much easier to treat than ovarian cancer, which is often diagnosed too late to benefit from conventional therapies.

Todd says she and Cuevas were also compelled to refocus their research energies because they found something very startling and very striking: women of all races have about the same incidence of uterine cancer, but the mortality rate for African-American women with uterine cancer is 2-1/2 times that of all other women with the same disease. We were completely blown away, Todd recalls. Why is it that the uterine cancer rate is not higher in African-American women but they die at much higher rates?

Todd and Cuevas knew there were many possible answers: Perhaps African-American women were not being diagnosed early enough because of limited access to healthcare. Maybe cultural distrust between African-American women patientsof all socioeconomic classesand their primarily white male doctors was preventing those women from advocating for their own care. And/or perhaps implicit bias was keeping patients from receiving sufficiently aggressive treatment. But these would be sociological responses and therefore beyond the scope of Todd and Cuevass research. From a biological standpoint, however, the pair could investigate which kinds of uterine cancer African-American women were being diagnosed with: Was it the more treatable endometrial cancer (i.e., malignancy of the lining of the uterus), or was it the more difficult-to-treat myometrial cancer (i.e., malignancy of the muscular wall of the uterus)? And if they were to look at tumor samples from women across racial identities, would they see differences in the ability of cancer cells to stay adhered to one another, or would those cells break off more frequently, making it easier for tumors to migrate through the bloodstream and spread (i.e., metastasize) to a different part of the body?

From cancer research to (better) cancer treatment

To help answer such questions about what causes cancer to spread throughout the body, Todd and her undergraduate research assistantspositions made possible by her funding as Southwesterns first Ed and Suzanne Morrow Ellis Term Chairwork with immortalized uterine tumors from women. That is, normal cells eventually stop dividing, grow old, and die; cancer cells, however, have short-circuited that aging process, so they can grow and replicate in perpetuity. So when patients have a tumor removed, researchers can actually continue to grow and examine immortal cell lines derived from that tumor. Todd says, I say that to the students: Just think about what it is that youre handling here in these flasks. These are cancer cells that are immortal, and they will outlive us and your children and your grandchildren. So we do treat them with a certain amount of reverence, actually.

With all due reverence, Solis, Seek, and Todd are studying claudin-3 and claudin-4, just two members of a family of 24 tight-junction proteins that create watertight seals between adjacent cells and help hold those cells together. Although one might expect that having high levels of something called tight-junction proteins would mean that the connections between cells would be even stronger, it turns out that claudin-3 and -4 are abnormally elevated in uterine cancer cells, and that disproportion of proteins actually makes it easier for malignant cells to shear off, spread to another organ, and grow secondary tumors. Todd believes that down the road, if she and her fellow researchers can correlate high levels of claudin-3 and -4 with certain stages of uterine cancer, that correlation can prove useful not just as a diagnostic marker but also as a prognostic one. That is, a doctor could tell a patient how much cancer is in the body and better predict how the cancer will behave, including how it will respond to treatment.

Anthony Seek 20, one of Todd's current research assistants, looks forward to applying his SU lab experience to a future career in pediatric oncology.

But most exciting to meand something that my lab and my students are working onare the possible treatment applications, Todd shares. She and her collaborators have been able to use a molecule known as small interference RNA to decrease the excessive amounts of claudin-3 and -4 to normal levels, which prevents the uterine cancer cells from migrating or moving across membranes as quickly. The hope, then, is that by decreasing the levels of these proteins, scientists will eventually be able to stop uterine tumors from metastasizing.

Thats obviously my goal as a cancer researcher and I think the goal of most people who go into cancer research, Todd says. We might not see those clinical applications in our working lives, possibly not even in our lives, but we build on one anothers work. Shes hopeful that gene therapies similar to those she and her students are experimenting with will one day complement conventional cancer treatments such as surgery, chemotherapy, and radiation. Or rather, given the physical and emotional trauma of surgery and the side effects and risks of chemotherapy and radiationwhich can damage DNA, have adverse effects on neighboring healthy cells, and lead to mutations that cause secondary cancersTodd adds, Im hopeful that in our childrens generation, gene therapy will be part of the treatment program, and by the time they have children, gene therapy will be the major tailored form of therapy and we will eliminate chemotherapy drugs or radiation altogether.

In April 2020, Todd and Cuevas will present their research at the annual meeting of the American Association for Cancer Research, where the theme will be Turning Science into Lifesaving Cure. Todd looks forward to sharing their latest findings with their scholarly colleagues, and shes thankful for her Ellis Term Chair funding because it will support her travel to the conference and because it means that the research we can do at Southwestern is comparable to that at a large R1 [research] institution, and were really excited about that. But she and Cuevas are also dedicated to translating their knowledge in ways that will benefit their students beyond academic or professional development. In a biology class, its not just about preparing for medical school or graduate school or teaching or industry; its about learning about our own health, our own journey, and how our bodies change on a continuous basis, Todd explains. Its just so important from an intellectual standpoint to understand the structures, the functions, and the mechanisms. But its also important from a very human perspective to understand the emotional component, the biological component, and the psychological component that contribute to our own well-being.

Read more:
Researching the Future of Cancer Treatment - Southern Newsroom

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Close to half of New Jersey's adult population either has diabetes or is one step away from the irreversible diagnosis.

And most of these folks don't even know it.

According to 2019 figures from the American Diabetes Association, approximately 862,000 people in New Jersey have the chronic disease, which affects a body's ability to produce or use the hormone insulin. More than 2.4 million other Garden State residents, meanwhile, have prediabetes blood glucose levels are higher than normal, but not yet high enough to be counted as a full-blown diabetes diagnosis.

It's believed that a little more than a quarter of diabetic adults are not aware of their condition, along with 90% of folks living with prediabetes.

"The key to really being able to prevent or manage diabetes is understanding your risk," said Lauren Grosz, executive director of the association's New Jersey and New York City markets. "If people are at high risk, we encourage them to see their doctor and get a blood test."

Every year in New Jersey, the association said, an estimated 39,000 people are diagnosed with diabetes.

With the diagnosis, individuals are at greater risk for other serious complications such as heart disease, stroke, end-stage kidney disease and blindness.

As part of American Diabetes Month, the association launched a campaign called Count Me In, which encourages those impacted by the disease to "get involved in the fight" by volunteering, becoming advocates and donating to the cause, and urges those who may be at risk to speak with their physician.

People with diabetes incur medical expenses more than two times higher than those who do not have diabetes, the association said. In New Jersey, total direct medical costs related to diagnosed diabetes were estimated at $6.7 billion in 2017.

Affordability is the biggest barrier to care for suffering individuals who do not have health insurance, according to the Diabetes Foundation. And whether or not someone has insurance, the foundation said, insulin is expensive.

"Depending on the type of insulin, the costs could be overwhelming," said Ginine Cilente, executive director of the Hackensack-based foundation, which helps people manage the disease and provides short-term medication for those who can't afford it.

The foundation's youngest participant last year was 3 years old. The oldest was 95.

"Diabetes is hard, and we think getting help shouldn't be," Cilente said. "We have come across a lot of people who say they are rationing their insulin."

Diabetes is the eighth leading cause of death in the Garden State, and the rate of new adult cases is increasing, according to the Department of Health.

The state says it is making progress in reducing the diabetes death rate, and increasing the percentage of diabetic adults who get an A1C test at least twice a year.

More from New Jersey 101.5:

Contact reporter Dino Flammia at dino.flammia@townsquaremedia.com.

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39,000 people in NJ are diagnosed with diabetes every year - New Jersey 101.5 FM Radio

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She did so a safe distance from her homeland, where LGBTIQ+ (Lesbian, Gay, Bisexual, Transgender/Transsexual, Intersex and Queer/Questioning) people regularly face persecution that is actively encouraged by political and religious leaders.

Just last month, a gender nonconforming LGBTIQ+ activist was brutally murdered in his own home. Hacked in the head with a gardening tool, according to Sexual Minorities Uganda.

Negesa is not exaggerating when she says: I cant go back home. I may lose my life.

So, the 27-year-old has become an asylum seeker, applying for indefinite leave to remain in Germany. She has been housed in a LGBTIQ+-friendly shelter while her case is considered. A decision is expected on Friday.

It has been several weeks since she said goodbye to her family and headed to Berlin. If her application is granted, there is no telling when she will see them again. They are missing me a lot, she says of those for whom her athletics career had been a route out of poverty. When they call me, they are asking when Im coming back.

But Negesa is defiant about her decision to end seven years of silence about how she was told just weeks before the London Olympics that she produced too much testosterone to compete fairly as a woman, how she found herself with one option for reducing it, how what she thought would be a simple procedure resulted in her internal testes being cut out, and how she felt so unwell afterwards that she feared she would die.

Read more:
Exclusive interview: DSD athlete Annet Negesa - 'My family miss me, but if I go back to Uganda I may lose my life' - The Telegraph

Recommendation and review posted by Bethany Smith

The first attempt in the United States to use a gene editing tool called CRISPR against cancer seems safe in the three patients who have had it so far, but its too soon to know if it will improve survival, doctors reported Wednesday.

The doctors were able to take immune system cells from the patients blood and alter them genetically to help them recognize and fight cancer, with minimal and manageable side effects.

The treatment deletes three genes that might have been hindering these cells ability to attack the disease, and adds a new, fourth feature to help them do the job.

Its the most complicated genetic, cellular engineering thats been attempted so far, said the study leader, Dr. Edward Stadtmauer of the University of Pennsylvania in Philadelphia. This is proof that we can safely do gene editing of these cells.

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After two to three months, one patients cancer continued to worsen and another was stable. The third patient was treated too recently to know how shell fare. The plan is to treat 15 more patients and assess safety and how well it works.

Its very early, but Im incredibly encouraged by this, said one independent expert, Dr. Aaron Gerds, a Cleveland Clinic cancer specialist.

Other cell therapies for some blood cancers have been a huge hit, taking diseases that are uncurable and curing them, and the gene editing may give a way to improve on those, he said.

Gene editing is a way to permanently change DNA to attack the root causes of a disease. CRISPR is a tool to cut DNA at a specific spot. Its long been used in the lab and is being tried for other diseases.

This study is not aimed at changing DNA within a persons body. Instead it seeks to remove, alter and give back to the patient cells that are super-powered to fight their cancer a form of immunotherapy.

Chinese scientists reportedly have tried this for cancer patients, but this is the first such study outside that country. Its so novel that it took more than two years to get approval from U.S. government regulators to try it.

The early results were released by the American Society of Hematology; details will be given at its annual conference in December.

The study is sponsored by the University of Pennsylvania, the Parker Institute for Cancer Immunotherapy in San Francisco, and a biotech company, Tmunity Therapeutics. Several study leaders and the university have a financial stake in the company and may benefit from patents and licenses on the technology.

Two of the patients have multiple myeloma, a blood cancer, and the third has a sarcoma, cancer that forms in connective or soft tissue. All had failed multiple standard treatments and were out of good options.

Their blood was filtered to remove immune system soldiers called T cells, which were modified in the lab and then returned to the patients through an IV. Its intended as a one-time treatment. The cells should multiply into an army within the body and act as a living drug.

So far, the cells have survived and have been multiplying as intended, Stadtmauer said.

This is a brand new therapy so not its not clear how soon any anti-cancer effects will be seen. Following these patients longer, and testing more of them, will tell, he said.

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Doctors try CRISPR gene editing for cancer, a 1st in the US - NBCNews.com

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All right, lets do this one last time. My name is CRISPR. I was made from a bacterial defense system, and for years Ive been the one and only gene editing wunderkind. Im pretty sure you know the rest. Im relatively cheap to make, easy to wield, and snip out genes pretty on target. Im going into clinical trials. Im reviving the entire field of gene therapy. Theres only one CRISPR. And youre looking at it.

Well, just as Spider-Man was way off, so is the idea of a single CRISPR to rule them all. This month, Dr. David Liu at the Broad Institute of MIT and Harvard in Cambridge, MA, introduced an upgrade that in theory may correct nearly 90 percent of all disease-causing genetic variations. Rather than simply deactivating a gene, CRISPR-based prime editing is a true search-and-replace editor for the human genome. With a single version, it can change individual DNA letters, delete letters, or insert blocks of new letters into the genome, with minimal damage to the DNA strand.

For now, prime editing has only been tested in cultured cells. But its efficacy is off the charts. Early experiments found it could correct single-letter misspellings in sickle cell disease, snip out four superfluous letters that underlie Tay-Sachs, and insert three missing letters to correct a genomic typo that leads to cystic fibrosis. In all, the tool worked remarkably well in over 175 edits in both human and mouse cells.

The excitement has been palpable, said Dr. Fyodor Urnov at the University of California, Berkeley, who was not involved in the research. I cant overstate the significance of this.

Given all of the existing CRISPR upgrades, why are scientists head over heels about prime editing?

CRISPR 1.0 generally refers to the classic version, which snips open the double helix to get rid of a certain gene. But as a tool, todays CRISPR is less like genetic scissors and more similar to a Swiss Army knife, one that scientists keep on improving. There are variants that, rather than destroying a gene, insert one or change one genetic letter to another, or ones that can target thousands of genetic spots at the same time. There are also spin-offs that hunt down RNAthe messenger that carries DNAs genetic code to the greater cellular universe, rather than the genetic code itself. Its truly a CRISPR multiverse out there.

Yet for all of CRISPRs upgrades, the tool has serious issues. For one, its very rough on the genome. Cas9, the protein scissor component of CRISPR, doesnt surgically cut out a gene. Rather, editing is in fact the cell detecting damage to the double helix, and trying its best to patch the broken strands back up. Just as scars form on our skin, this process can often introduce errors in the repairing processadding or missing a letter or two. Scientists often take advantage of this botched repair to destroy a gene that causes disease, or sneak in some additional code.

The problem? This process is basically genome vandalism, said Dr. George Church, a CRISPR pioneer at Harvard who wasnt involved in the new work. Its great when the repair goes according to plan; when it doesnt, the repair can introduce unwantedor downright dangerousmutations.

Lius idea for prime editing grew from his work on base editors. Here, the CRISPR machinery doesnt chop up the double helix. Rather, it uses the blood hound guide RNA to shuttle a new protein component to the target DNA sequence. This component then performs a single letter swap: C to T, or G to A.

Although considered much safer than traditional cut-and-glue CRISPR, base editors are limited in the number of genetic diseases they can treat. Its like editing on a broken keyboardsome misspellings just cant be fixed.

Prime editing circumvents these problems by heavily upgrading both components. The altered Cas9, for example, only snips a single strand of the double helix, rather than chomping through both. The new guide, pegRNA, both tethers the entire machinery to the target site, and encodes the desired edit.

Then comes the third component that magically ties everything together: a protein dubbed reverse transcriptase, which can make DNA sequences based on the blueprint in pegRNA, to insert into the nicked target site.

Still confused? Picture the DNA double helix as a laddertwo strands with connecting rungs in the middle. Prime editing cuts one strand using its neutered Cas9. This creates an opening for the other two components to insert a new gene into the severed spot; meanwhile, the original DNA sequence is snipped off. Now, rather than the original X, X (for example), the cell has X, Y.

The prime editor then performs a second snip at the opposing, non-edited strand. This alerts the cell of DNA damage, which it then tries to fixusing the new gene as a template. The end result is the cell goes from disease-causing X, X to normal, healthy Y, Y.

Several reasons.

One, because it doesnt cut both DNA strands, it doesnt immediately activate the cells repair system that is prone to errors. This means that scientists have far better control over the type of edit they want, and its no longer left to chance.

Two, prime is remarkably multi-purpose. Previously, the consensus among genome scientists was that a separate CRISPR tool was required for each specific type of edit: delete a gene, insert new DNA code, or DNA letter substitutions. In contrast, prime can achieve all three functions without additional modification. For experiments, it means less setup. For development into gene therapy, it means less overhead investment.

Three, prime editing can swap any of the DNA letters into any other, meaning it can now target an enormous amount of inherited diseases. For example, sickle cell disease, which causes oxygen-carrying blood cells to deform into sharp sickle-like shapes, requires changing a T into an A at a precise spot. Base editors cant do that. Prime editing can. Thats about 7,000 genetic disorders now amenable to gene therapy.

Four, prime editing also works in cells that no longer divide to renew themselves, such as neurons and muscle cells. Because these cells cant pass on their therapeutic DNA edit to daughter cells, to fix genetic deficits scientists have to be able to efficiently correct mutations in a large population. With prime editing, thats now possible.

Finally, prime editing can remove an exact number of letters from a given spot on the genome, at least up to 80. This allows scientists to precisely dictate the DNA sequences they want out, rather than relying on chance.

Early experiments with prime editing in cells show the tool is incredibly accurate. Off-target nicks were below 10 percent, and less than one-tenth of edited cells had unwanted changes to their genome, compared to up to 90 percent for first-gen CRISPR systems.

Nevertheless, the tool will have to go through rigorous testing before its widely accepted. Working in a few types of human cells is one thing; having it perform equally well inside a living body is something else completely. Most of primes tricks so far can be replicated using CRISPR 1.0, though at lower efficacy and with higher chances of off-target failures. Unlike prime editing, however, the original version has years of experience and plenty of clinical trials underwaycongenital blindness, sickle cell diseaseto back it up.

Whats more, prime is massive in terms of molecular tools. Getting it into cells will be a struggle. Getting it to the brain, which is protected by a dense wall of cells, will be even harder. To get the editor to their target, scientists will likely rely on gene therapy, itself a budding industry.

If CRISPR is like scissors, base editors are like a pencil. Then you can think of prime editors like a word processor, capable of precise search and replace, said Liu. All will have rolesThis is the beginning rather than the end.

Image Credit:petarg/Shutterstock.com

More:
Everything You Need to Know About Superstar CRISPR Prime Editing - Singularity Hub

Recommendation and review posted by Bethany Smith

A team of scientists from City University of Hong Kong (CityU) and the Karolinska Institute has created a novel protein that can increase the target accuracy in genome editing. Their findings are published in the journal Proceedings of the National Academy of Sciences (PNAS).Meet CRISPRThe gene editing technology Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 looks set to revolutionize modern medicine, agriculture, and synthetic biology.The ability to edit the genome in vivo offers the potential to develop novel gene therapies for diseases that currently lack viable treatment options. Several clinical trials are underway exploring the utility of CRISPR technology in treating specific cancers, blood disorders and eye diseases.CRISPR-Cas9 as a gene editing tool is superior over other techniques due to its ease of use. In traditional gene therapy, additional copies of the "normal" gene are introduced into cells. Using CRISPR technology, this isnt necessary; CRISPR-Cas9 enters the cell and "repairs" the problematic gene by removing it or correcting it to restore normal physiological function.

There are different components to the CRISPR mechanism. Cas9 is the enzyme that flags and locates the problematic DNA throughout the genome, acting in a "hunting" fashion. However, the precision of Cas9 cannot always be established, and occasionally modifications of DNA at unintended places can occur. If CRISPR is to be utilized to repair faulty genes in patients, potential off-target genome editing could have serious adverse effects.

There are currently two versions of the Cas9 enzyme commonly adopted in CRISPR research: SpCas9 (Cas9 nuclease from the bacteria Streptococcus pyogenes) and SaCas9 (Cas9 nuclease from Staphylococcus aureus). Both of these enzymes are limited in that they possess a certain level of imprecision.

Thus, scientists have endeavored to develop variants of both enzymes, with the aim being to increase their precision and reduce off-target effects. The issue with SpCas9 is that the modified variants are often too large to "fit" in the delivery system adopted for inserting gene therapies into patients, known as adeno-associated viral (AAV) vectors.SaCas9 is advantageous over SpCas9 in that it can be easily packaged into the AAV vectors for delivering gene-editing contents in vivo. However, at present, there is no SaCas9 variant that possesses high accuracy in genome-wide editing. Until now.Now meet SaCas9-HFIn the new study published in Proceedings of the National Academy of Sciences (PNAS), a research team led by Zheng Zongli, Assistant Professor of Department of Biomedical Sciences at CityU and the Ming Wai Lau Centre for Reparative Medicine of the Karolinska Institute in Hong Kong, and Shi Jiahai, Assistant Professor of Department of Biomedical Sciences at CityU, has successfully engineered SaCas9-HF, a CRISPR Cas9 variant which has demonstrated high accuracy in genome-wide targeting in human cells without compromising on-target efficiency.In the study, the scientists conducted an extensive evaluation of 24 targeted human genetic locations comparing the original (known as wild-type) SaCas9, and the new variant, SaCas9-HF. They discovered that for targets with highly similar sequences in the genome (and therefore often disposed to off-target editing by wild-type Cas9), SaCas9-HF decreased the off-target activity by ~90%. When assessing targets that had relatively less off-targeting editing by wild-type SaCas9, the SaCas9-HF enzyme produced little to no detectable off-target effects.

"Our development of this new SaCas9 provides an alternative to the wild-type Cas9 toolbox, where highly precise genome editing is needed. It will be particularly useful for future gene therapy using AAV vectors to deliver genome editing 'drug' in vivo and would be compatible with the latest 'prime editing' CRISPR platform, which can 'search-and-replace' the targeted genes," said Dr Zheng.Reference: Tan et al. 2019. Rationally engineered Staphylococcus aureus Cas9 nucleases with high genome-wide specificity. Proceedings of the National Aacademy of Sciences (PNAS). DOI: https://doi.org/10.1073/pnas.1906843116

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A Highly Precise Cas9 Enzyme, SaCas9-HF, Is Added to the CRISPR Toolbox - Technology Networks

Recommendation and review posted by Bethany Smith

What happened

Shares of Crispr Therapeutics (NASDAQ:CRSP) jumped nearly 23% last month, according to data provided by S&P Global Market Intelligence. The biopharmaceutical company announced a quarterly update demonstrating multiple areas of progress. The lead drug candidate, CTX001, is enrolling patients at six global sites for a phase 1/2 trial in transfusion-dependent beta thalassemia (TDT) and at 10 global sites for a phase 1/2 trial in sickle cell disease. Preliminary results are expected to be released before the end of 2019, which could have a profound effect on the pharma stock.

The gene-editing pioneer ended September with nearly $630 million in cash, which will come in handy next year when the company expects to have up to five clinical trials ongoing simultaneously. That includes plans to initiate the first clinical trial of CTX120 as a treatment for multiple myeloma in the first half of 2020, which should be followed by multiple trials involving CTX130 in solid tumors and white blood cell cancers.

Image source: Getty Images.

It's certainly difficult for investors to argue against the continuous execution of Crispr Therapeutics. The company was the first using CRISPR gene-editing technology to enter clinical trials, continues to advance multiple assets through the rigors of preclinical work and closer to the clinic, and partners with outside companies to augment its own capabilities. There's the highly visible partnership with Vertex Pharmaceuticals for CTX001 and other pipeline assets, but that's far from the only collaboration.

Crispr Therapeutics previously created a joint venture with Bayer, called Casebia Therapeutics, although control of the start-up will revert to Crispr before the end of 2019. Casebia will focus on programs in hemophilia, eye disorders, and autoimmune diseases. Bayer will have opt-in rights for multiple drug candidates.

Crispr is also collaborating with ViaCyte to develop a cellular medicine for treating type 1 diabetes, and with KSQ Therapeutics to develop CAR-T drug candidates with enhanced allogeneicity (read: grown from a single cell line and able to be used in any individual, in contrast to the strict donor matching required for current CAR-T medicines).

There's a long way to go before the company proves CRISPR gene editing can live up to the hype in human therapeutics, but the pioneer is the best positioned among its peer group. While there are major flaws with CRISPR gene editing that could keep the initial tools from ever being commercialized, Crispr Therapeutics is taking a "softer" approach with ex vivo engineering of white blood cells in blood disorders and for immuno-oncology. Whether the approach yields success remains to be seen, but investors will get their first glimpse of the potential when preliminary results from CTX001 trials are announced in the coming months.

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Here's Why Crispr Therapeutics Gained 22.8% in October - Motley Fool

Recommendation and review posted by Bethany Smith

REPORTING FOR 2019-11-08 | WCX19.ORG: We have done an in-depth analysis of how YGYI has been trading over the last 2 weeks and the past day especially. On its latest session, Youngevity International, Inc. ($YGYI) opened at 4.17, reaching a high of 4.3645 and a low of 4.17 before closing at a price of 4.28. There was a total volume of 40813.

VOLUME INDICATORS FOR YOUNGEVITY INTERNATIONAL, INC. ($YGYI): We saw an accumulation-distribution index of 48.46941, an on-balance volume of -4.21, chaikin money flow of 1.0 and a force index of 0.01053. There was an ease of movement rating of -0.00099, a volume-price trend of -0.48511 and a negative volume index of 1000.0.

VOLATILITY INDICATORS FOR YOUNGEVITY INTERNATIONAL, INC. ($YGYI): We noted an average true range of 0.19856, bolinger bands of 4.18124, an upper bollinger band of 4.14646, lower bollinger band of 4.17, a bollinger high band indicator of 1.0, bollinger low band indicator of 1.0, a central keltner channel of 4.23483, high band keltner channel of 4.04033, low band keltner channel of 4.42933, a high band keltner channel indicator of 1.0 and a low band keltner channel indicator of 1.0. There was a donchian channel high band of 4.17, a donchian channel low band of 4.17, a donchian channel high band indicator of 1.0, and a donchian channel low band indicator of 1.0.

TREND INDICATORS FOR YOUNGEVITY INTERNATIONAL, INC. ($YGYI): We calculated a Moving Average Convergence Divergence (MACD) of -0.00028, a MACD signal of -0.00015, a MACD difference of -0.00012, a fast Exponential Moving Average (EMA) indicator of 4.17, a slow Exponential Moving Average (EMA) indicator of 4.17, an Average Directional Movement Index (ADX) of unknown, an ADX positive of 20.0, an ADX negative of 20.0, a positive Vortex Indicator (VI) of 1.0, a negative VI of 1.0, a trend vortex difference of 0.1596, a trix of -7.37562, a Mass Index (MI) of 1.0, a Commodity Channel Index (CCI) of 66.66667, a Detrended Price Oscillator (DPO) of 0.55384, a KST Oscillator (KST) of -117.24453 and a KST Oscillator (KST Signal) of -117.24453 (leaving a KST difference of -0.65095). We also found an Ichimoku rating of 4.26725, an Ichimoku B rating of 4.26725, a Ichimoku visual trend A of 4.84938, an Ichimoku visual trend B of 4.712, an Aroon Indicator (AI) up of 4.0 and an AI indicator down of 4.0. That left a difference of -4.0.

MOMENTUM INDICATORS FOR YOUNGEVITY INTERNATIONAL, INC. ($YGYI): We found a Relative Strength Index (RSI) of 50.0, a Money Flow Index (MFI) of 34.96838, a True Strength Index (TSI) of -100.0, an ultimate oscillator of -54.12626, a stochastic oscillator of 100.0, a stochastic oscillator signal of 100.0, a Williams %R rating of 1326.2069 and an awesome oscillator of 0.04847.

RETURNS FOR YOUNGEVITY INTERNATIONAL, INC. ($YGYI): There was a daily return of -11.72445, a daily log return of -0.2954 and a cumulative return of -0.29496.

What the heck does all of this mean? If you are new to technical analysis, the above may be gibberish to you, and thats OK (though we do advise learning these things). The bottom line is that AS OF 2019-11-08 (if you are reading this later, the analysis will be out of date), here is what our deep analysis of technical indicators are telling us for Youngevity International, Inc. ($YGYI)

DISCLAIMER: We are not registered investment advisers and the above analysis should be taken at face value only. We strongly advise against buying or selling Youngevity International, Inc. ($YGYI) based solely on our analysis above, and are not responsible for any losses that you may incur if you choose make any investment decisions based on the above.

Continued here:
CRISPR Therapeutics AG ($CRSP): Caution Is Advised (2019-11-08) - WCX19

Recommendation and review posted by Bethany Smith

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Cryonics Technology Market Insights and Technology Growth 2019, Forecasts to 2025 - The Market Publicist

Recommendation and review posted by Bethany Smith

Given the amount of wear and tear its subjected to on a daily basis, the skin has a phenomenal ability to replenish itself. Spread throughout it are small reservoirs of stem cells, nested within supportive microenvironments called niches, which keep a tight rein on this repair process. Too much tissue might cause problems like cancer, while too little might accelerate aging.

Until now, scientists were uncertain whether the stem cells themselves could instruct other stem cells to form new skin by reshaping their niche. But new research in Science, led by Elaine Fuchs, the Rebecca C. Lancefield Professor, indicates that stem cells can indeed influence tissue regeneration. The study identifies a molecular coordination tool used by stem cells to signal across niches.

The researchers also discovered a new component of the niche: a specialized type of vessel called lymphatic capillaries, which transport immune cells and drain excess fluids and toxins from tissues. These capillaries form an intimate network around the stem cell niche within each hair follicle, the study showed, thereby interconnecting all its niches.

By turning the skin completely transparent, says postdoctoral fellow Shiri Gur-Cohen, we were able to reveal the complex architecture of this network of tubes.

Hair-follicle stem cells control the behavior of lymphatic capillaries by secreting molecules that act as an on-off switch for drainage, the scientists found, enabling them to control the composition of fluids and cells in the surrounding locale and ultimately synchronize regeneration across the tissue.

The involvement of the lymphatic system in this process is a new concept, says Fuchs, and might potentially provide new therapeutic targets for lymph-related conditions such as wound-healing defects and hair loss.

Reference

Gur-Cohen et al. (2019) Stem celldriven lymphatic remodeling coordinates tissue regeneration. Science. DOI: https://doi.org/10.1126/science.aay4509

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Lymphatic System Discovered To Play Key Role in Hair Regeneration - Technology Networks

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Scientists have devised a technique to determine which heart cells can replicate and which cannot, a critical step toward treatments that may one day help the heart heal itself after injury.

The method removes a significant roadblock to developing ways to regrow healthy cardiac muscle tissue, a feat not currently possible.

This new technique solves a longstanding problem that for years has stymied our ability to develop regenerative treatments for the heart, said Stefan Jovinge, the studys senior author and director of the DeVos Cardiovascular Research Program at Van Andel Institute and Spectrum Health. Its a major step forward that we aim to translate into improved patient care.

For decades, scientists have searched for ways to harness the hearts regenerative potential to fix damage related to heart attack and heart failure, but their attempts have been largely unsuccessful.

Unlike the skin or bones, which readily heal by stitching together wounds or breaks with new, healthy cells, heart muscle cells largely lose their ability to replicate early in life (instead, they progress through the cell cycle but, in most cases, they do not actually divide). This leaves patients and physicians with only a few surgical options to mitigate further damage and just one option to totally repair the problem should the damage be too severe: a heart transplant.

The new method combines two technologies molecular beacon technology and fluorescence activated cell-sorting to specifically isolate cells that successfully divide. This will allow scientists to determine the mechanisms underlying heart muscle cells regenerative potential, which is critical to the development of regenerative strategies aimed to cure patients with heart injury.

Now that we can accurately identify these cells, we can start to determine the mechanisms that allow them to divide and develop ways to jump-start this process, Jovinge said. This work is an excellent example of how basic research can have a major impact on future clinical care.

The findings build on previous research by Jovinges team that showed, contrary to long-held beliefs, some cells in the heart are indeed capable of replicating.

Reference

Milliron et al. (2019) Isolation of Cardiomyocytes Undergoing Mitosis with Complete Cytokinesis. Circulation Research. DOI: https://doi.org/10.1161/CIRCRESAHA.119.314908

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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New Technique Lays Foundation for Regenerative Cardiac Therapies - Technology Networks

Recommendation and review posted by Bethany Smith

Human heart cells are changed by spaceflight but return to mostly normal on Earth, according to a study that examined how the human heart functions in spaceflight. The scientists were surprised as to how quickly human heart muscle cells could adapt to the environment in which they are placed.

The research team examined the cell-level cardiac function and gene expression in human heart cells that were cultured aboard the International Space Station (ISS) for 5.5 weeks. They found that heart muscle cells -- derived from stem cells -- adapted well to their environment during and after spaceflight.

The analysis, says the team, shows that exposure to microgravity altered the expression of thousands of genes, but largely normal patterns of gene expression reappeared within 10 days after returning to Earth.

These findings provide insight into how the human heart functions at the cellular level in spaceflight. This study suggests that the human heart muscle cells are very adaptable to the environment in which they are placed, including microgravity. Microgravity is an environment that is not very well understood in terms of its overall effect on the human body, and studies like this will be able to help shed light on how the cells of the body behave in space," Dr. Joseph C. Wu, Director, Stanford Cardiovascular Institute at Stanford University School of Medicine, told MEA WorldWide (MEAWW).

The researchers explain that human heart muscle cells, like the whole heart, change their functional properties in spaceflight and compensate for the apparent loss of gravity by changing their gene expression patterns at the cellular level.

"This study does not tell us how the heart as a whole changes in microgravity. There are several other types of cells in the heart that were not included in this study. We also do not know how the cells might react if they were exposed to microgravity for a longer period of time. However, these are both things we can test in the future. The results we observed in this study will allow us to focus those future studies on characteristics of the heart muscle cells we know are strongly affected by microgravity," Dr. Wu told MEAWW.

With extended stays aboard the ISS becoming commonplace, there is a need to better understand the effects of microgravity on cardiac function, say experts. Past studies have shown that spaceflight induces physiological changes in cardiac function. Astronauts on space shuttle missions have experienced reduced heart rate, lowered arterial pressure, and increased cardiac output. But to date, most cardiovascular microgravity physiology studies have been conducted either in non-human models or at tissue, organ, or systemic levels, says the team.

"The National Aeronautics and Space Administration [NASA] Twin Study demonstrated that long-term exposure to microgravity reduces mean arterial pressure and increases cardiac output. However, little is known about the role of microgravity in influencing human cardiac function at the cellular level," says the study published in 'Stem Cell Reports'.

Accordingly, the research team used human induced pluripotent stem cells to study the effects of spaceflight on human heart function.

"We studied human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). We generated hiPSC lines from three individuals by reprogramming blood cells and then differentiated them into hiPSC-CMs," says the study.

Dr. Wu explains that human induced pluripotent stem cells (hiPSCs) are stem cells that can be produced from a small sample of blood or skin through a process called "reprogamming".

"These hiPSCs can be then turned into almost any cell type of interest, including beating human heart muscle cells, or cardiomyocytes. Since these hiPSC-derived cardiomyocytes mimic the function of true adult human heart cells, we can use them as a model for how the cells of the human heart respond to microgravity," Dr. Wu told MEAWW.

Beating hiPSC-CMs were launched to the International Space Station aboard a SpaceX spacecraft, as part of a commercial resupply service mission. Simultaneously, ground control hiPSC-CMs were cultured on Earth for comparison.

"Upon return to Earth, space-flown hiPSC-CMs showed normal structure and morphology. However, they did adapt by modifying their beating patterns and calcium recycling patterns," the findings state.

The researchers performed RNA sequencing. "These results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples. A comparison of the samples revealed that hiPSC-CMs adopt a unique gene expression pattern during spaceflight, which reverts to one that is similar to groundside controls upon return to normal gravity," says the study.

The findings, according to the researchers, could provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth.

"We know that humans can spend months and years in space. Through decades of analyses, we know that the human heart as a whole organ changes its shape, size, and function in spaceflight. These changes are one reason why astronauts must exercise in space for hours every day to keep their heart muscles strong. While our cell-based experiments were able to confirm that changes also occur on the cellular level, we cannot directly translate this to the organ-level without further studies. The changes in our hiPSC-cardiomyocytes are not adverse effects, but rather adaptations to microgravity. The changes reflect how the cells of the human body can quickly adapt to a low gravity environment," Dr. Wu told MEAWW.

The research team now plans to test different treatments on the human heart cells to determine if they can prevent some of the changes the heart cells undergo during spaceflight.

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Human heart cells change during spaceflight, say scientists in study that could have far-reaching effects on c - MEAWW

Recommendation and review posted by Bethany Smith

Beauty/6 November 2019, 2:00pm/LIZ HOGGARD

London - On the run up to her 50th birthday, Charlotte Vhtz noticed her skin was changing.

"When youre a child, skin renewal takes place every three to five days," she says. "But when you get into your 50s, it takes two to three months. Even if you apply the most amazing expensive cream, its going on top of dead skin cells. It cant penetrate, so it wont work."

An organic beauty pioneer, Charlotte didnt want to use chemical "tweakments", so she started researching cutting-edge, scientifically proven botanicals that could delay ageing.

"I knew I needed to find a way to exfoliate the skin without being too harsh. I love wrinkles, but I dont like dry, sagging skin."

A former nurse, Charlotte has a background in pharmaceuticals and is fascinated by science. But she also believes passionately in the power of nature.

After six years of research, Charlotte, now 60, has just launched her signature range, Age Defy+ by Cha Vhtz, a natural skincare regime that uses a blend of innovative plant-based alternatives aimed at skin aged 30, 40, 50 and beyond.

Here, she explains how anti-ageing plant extracts, among them pomegranate, hibiscus, neroli and sea holly, can be just as effective.

Skin-plumper

SWAP: Botox for hibiscus. With its magical reputation for increasing skin elasticity, its no wonder hibiscus is called the Botox plant.

It has an incredible ability to inhibit the activity of the enzyme elastase, which is responsible for breaking down our skins precious elastin.

Hibiscus actively combats the ageing process by firming and lifting your skin, allowing it to snap back.

Because of the slightly exfoliating effect of the organic acids found in the plant, hibiscus also helps speed up cell turnover, resulting in a more even-looking skin tone.

It can even help to control acne breakouts, bringing your skin back in balance for a gorgeous, glowing complexion.

Hibiscus also enhances the skins ability to retain moisture, a key factor in keeping a youthful complexion.

Wrinkler-buster

SWAP: Hyaluronic acid (a much-used additive in anti-ageing creams) for beech bud extract.

Beech bud extract is an exceptional ingredient, rich in a range of substances that boost the metabolism, smooth the skins surface and restore hydration.

Perhaps its no surprise that the beech is known as the Everlasting Youth Tree.

Exfoliator

SWAP: Alpha Hydroxy Acids, or AHA (chemical compounds used in abrasive cosmetic exfoliators) for pineapple extract.

Exfoliate dead skin cells by rubbing a thin slice of pineapple or papaya over your face. Leave for five minutes, then rinse off with tepid water.

Pineapple extract is rich in skin-boosting vitamins C and E and bromelain, a protein-digesting enzyme.

Rejuvenator

SWAP: Butylene Glycol (a type of alcohol used as a solvent in anti-ageing serums) for sea holly.

A beautiful, purple, thistle-like plant, sea holly is amazing because it has evolved to survive in the harshest conditions.

An extract is obtained from cultured plant stem cells, which contain all the attributes of the whole plant and, as a result, have powerful regenerative and rejuvenating properties.

Sea holly stimulates and protects the skins natural elastin and collagen, both of which decrease as you age, resulting in greater skin radiance and luminosity.

Anti-ager

SWAP: Dermal fillers for extract of the herb baikal skullcap.

Much-used in Chinese medicine, the extract baicalin comes from the roots of baikal skullcap, a herb in the mint and sage family native to East Asia.

Its an ingredient with remarkable anti-ageing properties in adults aged 30 or over.

Hydrator

SWAP: Retinol (a popular chemical skincare ingredient) for squalane.

Squalane is the saturated, or stable, form of the compound squalene, originally obtained for commercial purposes from shark liver oil, but today extracted from olive oil.

Adult skin is lubricated and protected against external aggressors by the sebum our skin produces. In healthy skin, sebum contains 10 percent to 13 percent squalene. This level drops as we get older.

Read the original post:
Natural anti-ageing alternatives that actually work - IOL

Recommendation and review posted by Bethany Smith

Twenty seconds. Give or take.

Spencer Beach cant say for sure just how long he was on fire.

Long enough to stumble to two exitstwiceand yank on door handles that wouldnt budge.

The flash fire that engulfed him in an Edmonton home was sucking in all the oxygen, creating a vacuum that sealed him inside. A flooring installer by trade, he had been removing linoleum in the laundry rooma rush job since the manufacturer mislabelled the boxes and the contractor didnt want to incur penalties for a delay. Beach and the rest of the crew were often told to use their boss homemade shortcut: douse the flooring in a contact thinner to reactivate the glue. That way, you could just peel it off.

He was on his hands and knees when he first heard a whistle as loud as a thousand kettles, followed by a boom as the furnace set the fumes alight.

Now the skin on his face felt like it was shrinking. His lips, like theyd been swarmed by bees.

The heat was inside of me. It wasnt like any burn youve ever felt, Beach says. It was everywhere.

With no way out, he curled up on the floor, interlocking his fingers behind his head. His mind flashed to his wife, Tina, blonde and four months pregnant with their first child. He had just left her a voice message: the job was nearly done, he was the only one left, hed be home soon. Tonight, hed plan his buddys stag party.

Beach got to his feet and tried the door one more time.

In his right hand, Dr. Sarvesh Logsetty holds a pair of scissors. In his left, a piece of paper grabbed from the many stacks in his office at Winnipegs Health Sciences Centre (HSC), where he is head of the burn unit.

The surgeon is stumped.

Hes trying to remember the strategic cuts to make for a trick he would do as a kid. Its a paper craft that turns a 4-by-5-inch sheet into an open shape large enough to walk through.

What am I doing wrong?

Logsetty wants to use the analogy to explain the skin graft meshing techniques he routinely does for patients whove suffered severe burns to large swaths of their body. The techniques also use strategic cutsto expand pieces of skin up to nine times their original size.

Every centimetre counts in these life-saving reconstructive surgeries where patches of unharmed skin are removed from one site to cover another, explains the University of Manitoba professor of surgery and psychiatry.

Ta da, he says, holding up the large paper circle. Damn, that was driving me insane.

Dr. Sarvesh Logsetty's curiosity about suturing goes back to age four, to Hyderabad, India, where he would hang around the medical clinic run by his great-aunt // PHOTO BY DAVID LIPNOWSKI [BA(HONS)/08]

Finding solutions is what the 51-year-old has spent decades doing, to alleviate pain and hardship for burn patients. Each one of my research projects, he says, reflects a patients journey.

Logsetty knows Beachs well, having operated on him more than a dozen times. He was working the day Beach was rushed to University of Alberta Hospital. The surgeon remembers how this 29-year-oldwith burns to more than 90 per cent of his bodywas more worried about how others would handle the news than he was his own chances for survival (about five per cent).

Even afterwards, hes always thought about how he can help other people and how he can use his experience to help them get through, says Logsetty, who brought his expertise to UM in 2007.

One persons recovery involves a slew of professionals.

Beyond nurses to do dressing changes, there are dietitians, physiotherapists, occupational therapists, psychologists, psychiatrists and social workers. On the burn ward at HSC, the team includes UM students across disciplines. The unit admits 100 to 200 patients a year, and treats another 250 to 400 (including cases of frostbite and flesh-eating disease). About 40 per cent of patients are children. Among the adults, the majority are men, who tend to engage in riskier behaviour than women, Logsetty notes.

When compared to other health conditions, theres an added layer. With any burn, theres a sense of guilt. Did I do something that caused this? Especially as a parent. That adds to the burden, says Logsetty. Its different than something spontaneous like cancer, where it isnt that they left the oil on the stove for too long or didnt check the temperature when they put their child in the bathtub.

With any burn, theres a sense of guilt. Did I do something that caused this? Especially as a parent. That adds to the burden. SARVESH LOGSETTY

Among 20- to 60-year-olds, burns are most often flame-related mishaps involving cooking oils catching fire, accelerants flashing back while burning grass, or house fires erupting in the night, Logsetty says. Burns from scalding are most common in kids and the elderly.

His research probes what social determinants increase your chances. A study released with UM psychiatrist Dr. Jitender Sareen [MD/95, BSc(Med)/95] last year showed people with a low income were as much as five times more likely to suffer burns. And the researchers mapped high-incidence areas in Winnipeg for policymakers to target prevention strategies.

Logsetty offers a window into the daily challenges on the burn unit. Within its dual-chamber isolation rooms, theres an ongoing battle against infection, down to the microscopic fibres of hospital curtains that may harbour antibiotic-resistant bacteria.

Burn patients face a far greater risk because their injuries arent straightforward open wounds. Theres dead skin sitting there, providing a perfect food source for bacteria. And because the skin is dead, theres no link to the bodys blood. No trigger to get infection-fighting white blood cells to activate and defend. So the bacteria can happily grow, getting stronger, says Logsetty. The risk of infection is really high.

The seeping wounds are kept covered and clean. Peeling off the dressings can be excruciatingly painful and take hours. No matter what we use, the dressings tend to stick, says Logsetty. This agony is what drives him and UM collaborator Song Liu, a medical microbiology and infectious diseases researcher, also in the Rady Faculty of Health Sciences, in their efforts to reinvent the burn bandage.

Together, theyre developing not only a less sticky coating but a dressing they hope will transform burn care. Theyre designing a fabric to detect infection, alert medical staff by changing colour, and then release antibiotics from withinall without having to remove it, Logsetty says.

Different colours would indicate different bugs. If the spot of colour were to grow bigger, it would tell nurses the infection wasnt getting any better. The bandage will be made of nanofibres, or straw-like chemical structures that break down when they come into contact with bacterial enzymes. The centres will be filled with either a liquid to release dye or a liquid containing the antibiotic. A bandage that both diagnoses and treats infection would be a first in the field. Logsetty says they could have a tangible product in as little as five years.

Liu also holds a patent for an antibiotic-resistant fabric, which could one day mean self-cleaning hospital curtains. He bonded a chlorine-like chemical to the curtain that kills bacteria on contact, one that not only wont wash out in the laundry but is reactivated by water. One of Logsettys recent studies showed that, within two weeks of being washed, five out of eight untreated hospital curtains tested positive for antibiotic-resistant MRSA.

PHOTOS BY AMBER BRACKEN

Leather hiking boots. Leather knee pads. A leather work belt. Beach didnt think twice about the gear he put on the morning of Aug. 24, 2003. (But he did contemplate calling in sickjust a feeling that he should, but one he ignored.)

The leather is what saved the less than 10 per cent of Beachs body surface that wasnt burned. His feet below the ankles. A patch in the middle of each knee. His waistline.

Theres a line around my waist where you could see where my belt was, he says.

Only once the vapours and air pressure subsided in the home was he able to open the door to the garage and escape. A neighbour then came running with a hose.

Since that day, Beach has undergone 38 surgeries.

His burns reveal the most severe form: third- and fourth-degree, which tear through the epidermis and dermis and extend into the muscle, fat and bones. At first, these sites (that appear white or charred-black) are the least painful for patients, since the flames have destroyed the nerve endings.

While lesser burns can heal on their ownas cells lining our sweat ducts and hair follicles automatically spread out to rebuildsevere burns require grafting.

Skin from Beachs feet is now on his face. As is skin from his knees and hip. Pieces of his foreskin form his delicate, upper eyelids while skin from his scrotum shapes his lower.

Logsetty can use meshing instruments that stretch and expand what small percentage of skin survivesthe graphs look like criss-crossed grids, almost translucentbut each time he does, the skin gets thinner, leaving more room for scar tissue to fill in the gaps. Its the scarring that leads to chronic pain.

[With Beach] I had to take three per cent and expand it into more than 90 per cent, somehow or another, says Logsetty. The key to advancing burn care, he says, is to develop ways to grow better skin.

[With Beach] I had to take three per cent and expand it into more than 90 per cent, somehow or another. SARVESH LOGSETTY

Beach received synthetic skin, as well as skin from cadavers, before new skin was cultured from his own cells. With Logsetty at the helm, Beach became the firstand is still the onlyCanadian to receive a unique, double-layer skin thats more resilient than anything thats come before. A sample of his skin, the size of a business card, was cultured in a lab in Cincinnati, OH, and then multiplied time and time again to eventually cover nearly half his body.

Experimental in the early 2000s, the technique is still innovative today, says Logsetty, but not yet widely available because the company has faced hurdles bringing it to market. From an overall standards of burn care, its a gamechanger, he says.

Even though there are still improvements to makethe skin doesnt contain pigment, hair follicles or sweat ducts (so on a hot summer day, Beach has to watch for heat stroke)it means less scarring and greater quality of life, says Logsetty.

Hes also in the process of developing a research project at UM that will explore new ways to use stem cells to create skin, and is collaborating with a Quebec company, Loex, on a similarly robust skin alternative.

Skin-grafting surgeries can be marathons of endurance and difficulty. An intensive operation can take 12 hours, but shorter is best since patients are already so unstable going in. The temperature of the room is kept at 29.9C to prevent patients from becoming hypothermic. Their whole body is exposed on the tablein order to graft different areasand without skin, theyre without a key organ that helps regulate body temperature. When our temperature drops, we bleed more, so theres also a greater risk of bleeding out on the table. Disposable warming blankets, inflated with warm air, help retain heat.

In the stifling environment, Logsetty and the team wear surgical gowns made of Gortex or other waterproof fabrics. (One of his research projects studies the effects on the medical team, including how much weight they lose from sweat during a procedure.)

On this ward, named after Manitoba firefighters, the mortality rate is less than three per cent, on par with the top burn centres across North America, notes Logsetty. Not many of their patients are firefighters nowadays, given how safety training and gear have evolved. But unfortunately, when they do become injured, he says, its usually devastating.

Nine months after the fire, Beach rolled over for the first time. He had lost 63 pounds and at six-foot-two was down to 112. The scar tissue had built up on his ligaments and tendons, and his muscles were wasting away with atrophy. The movement was small but it felt like a big win that came just in time. After the fire, he was angry, depressed, suicidal; now he wanted to see what else he could do for himself.

With progress comes greater survival rates, which mean more people living with the long-term consequences of burn injuries like disability, financial problems and chronic pain. Trauma survivors are at least four times more likely to take their own life, Logsetty and Sareen revealed in a 2014 study. Theyve since discovered theyre also twice as likely to have depression, anxiety or substance-abuse issues.

The standard of care I try to hold myself toand teach my studentsis What would you expect for you or your loved one? SARVESH LOGSETTY

Logsetty says patients often tell him they dont want to go on. He helps them reintegrate with the life they once had, as much as possible. Its not, I fixed your hernia, your sutures are out, you can call me if you have a problem. There is a continuity of care we dont see in most other surgery.

Thats why hes made this his lifes work. One patient describes Logsetty as the most caring and considerate doctor I have ever met; another says he created a place of love in the burn unit.

The only burn expert between Edmonton and Toronto, he makes himself available 24-7 to residents and nurses, even when not officially on call. The standard of care I try to hold myself toand teach my studentsis What would you expect for you or your loved one? says the father of two kids (under age seven), and husband to epidemiologist Rae Spiwak [BA(Adv)/00, MSc/04, PhD/17], who also studies mental-health issues in trauma patients. The biggest thing Ive learned is that life can change in an instant.

This summer, Logsetty spoke at Winnipegs inaugural Face Equality Awareness event for people living with facial differences. Its important, he adds, to help people understand that, although the outside of somebody might have changed, the inside is still the samepart of what our team does really well is help burn survivors come to that understanding themselves.

It was Beachs wife who held up the mirror for him the first time, only once hed consulted with a psychologist. He couldnt bring himself to look beyond his nose, with its missing lobes and exposed bridge. Gone was the dimpled grin of a guy who was always the life of the party.

Now, if kids stare at the grocery store, hell engage with a smile and a wave. Often, they think hes just really olda grandpa, not a father, to his kids, he says. When adults approach, which hes totally fine with, its always the same question: Can I ask what happened?

Beach doesnt have photos of what he used to look like up in his house, only because theyre not picture people. And no longer does he appear as his former self in his dreams.

Im extremely proud of who I am, Beach says.

Hes a motivational speaker who finds fulfillment in trying to create positive change in the workplacewhos spoken to Winnipeg workers about putting safety before money and supervisors demands. But his life isnt without ongoing challenges.

He has nerve damage and reduced mobility in his joints.

(He says he has the equivalent of seven-and-a-half fingers, since doctors had to amputate portions, up until they found blood flow.) And with some stubborn wounds that wont heal, he regularly gets blood infections20 in the last 10 years. Nonetheless, he renovated his basement and next, hell build a fence.

Im extremely proud of who I am. SPENCER BEACH

With burn survivors like Beach, Logsetty notes, The scar doesnt define them. They define themselves.

In a recent Facebook post, he signed off one tough son-of-a Beach.

You want to be the person you used to be, Beach says, but now you have a different body to do it with.

He returnedjust onceto the site where it happened. Where a new house now stands.

I had to see it.

Early in his career Dr. Sarvesh Logsetty saw how each burn unit across the country was labouring in its own bubble. We have some very good burn centres across Canadapeople are doing great work and researchbut we didnt really work together as a burn program in Canada as a community.

When he joined UM in 2007 he established the Advancement of Burn Care Network and made Winnipeg its base. And last year he launched the Canadian Burn Association and annual symposium further connecting the multidisciplinary players in burn care including firefighters and survivors to learn whats working whats not and what to try next.

He says research in burn treatments is grossly underfunded since there are fewer champions for the cause. Were still at the infancy of really understanding wound healing says Logsetty how to improve it how to avoid scars where we can and how we can make them better.

While the frequency of burns has dropped dramatically since the 1960swith greater safety awareness smoke detectors and legislation to safeguard water heaterstrauma as a whole is still the leading cause of death in Canadians 40 and under. It costs the system more money than just about any other health-care problem thats out there, yet we barely hear about traumatic injury says Logsetty who as a general surgeon is also tasked with removing knives from abdomens after weekend violence, or bowels burst in car collisions. In the last week alone hes removed two spleens ruptured in crashes.

What frustrates me from an academic perspective is that trauma doesnt have a home. There is no institute for traumait gets lumped in under muscoskeletal health and arthritis. That means, in terms of resources, were struggling with identification of the importance of trauma and struggling with helping people understand why we do the research we do and how it affects the people that it affects.

Original post:
UM Today the Magazine | Fall 2019 | After the Fire - UM Today

Recommendation and review posted by Bethany Smith

PRP, or platelet-rich plasma, is part of a revolution in medicine. PRP contains an abundance of growth factors that play a valuable role in healing many ailments. The PRP technology has been developing for the benefit of patients, resulting in improved outcome and great results.

Platelet-rich plasma has evolved over the past 15 years from an experimental treatment and an idea that concentrated platelets can heal injuries to an everyday treatment that benefits so many. Platelets are concentrated by taking your blood in a tube or syringe and spinning the blood in a high-speed centrifuge that causes the components of blood to separate, including the red blood cells, white blood cells and platelets. The first generation of platelets involved one or two spins to separate the platelets, often including an anticoagulant to prevent clotting and solidifying of the platelets so it can be spread as a liquid around the target. This PRP has been effective for a range of musculoskeletal conditions. The second generation of PRP involves formation of a platelet-rich fibrin matrix (PRFM) that is valuable as a gel that can be applied to wounds, surgical sites and for dental conditions.

The third generation of PRP, also called CGF or concentrated growth factors,

was first developed and described in 2006 by an Italian physician (Dr. Sacco) and has recently become widely available in the United States with the Medifuge centrifuge. With a single spin, the blood is spun at multiple speeds, which concentrates the platelets while also isolating cells that express CD34+. This is a type of stem cell that greatly enhances the effectiveness of the platelets. The other advantage of this third-generation PRP is that without anticoagulants the platelets can be applied quickly as a liquid to apply to injured tendons and ligaments or for cosmetic benefit. By waiting a few minutes the platelets solidify, which is great for applying to wounds. Even when applied as a liquid, the third generation platelets solidify soon after injected, which helps attach the platelets to the area injected. This allows the platelets to provide growth factors for a longer duration to increase effectiveness.

There are many applications for this advanced PRP. Ligament and tendon injuries respond very well to PRP. These injuries often do not heal spontaneously because the ligaments and tendons do not get good blood flow. With PRP and its accompanying growth factors, the tendon and ligament is able to finally heal, providing long-term relief. In contrast to a steroid injection, which provides short-term relief and may contribute to tissue degeneration, PRP helps build and strengthen tissue and provides long-term relief.

To clarify, tennis elbow, golfers elbow, rotator cuff tendonitis, wrist tendonitis, iliotibial band syndrome, Osgood-Schlatters and Achilles tendonitis are all examples of tendon injuries characterized by weakening of the tendon fibers or even partial tears. PRP strengthen the tendon and heals all of these conditions.

Ligament injuries include all joint sprains and strains such as ankle sprains, shoulder strains, etc. The hallmark of joint arthritis is weakening of the ligaments that leads to wear and tear of the joint, with a cascade of cartilage erosion that leads to bone spurs, then joint space narrowing and eventually bone on bone. Any time you see a bone spur, chances are that there is a loose ligament that created the conditions that led to that spur. Platelets heal the ligaments so that the joint is more stable and the arthritic pain is relieved and recurrent ankle sprains stop recurring.

Thus, PRP is very effective for arthritic joints, including knee arthritis, hip arthritis and shoulder arthritis among others. The PRP is effective at strengthening the joint capsule that is comprised of ligaments and can provide support for the joint cartilage. Even with severe bone-on-bone arthritis, PRP can help strengthen the ligaments around the joint, which helps reduce pain.

PRP can also help you improve your appearance. With the vampire facial you get the benefit of the healing growth factors, which lead to increased collagen and blood flow for skin rejuvenation. The great aspect of this treatment is that this is a very natural way to naturally enhance your skin. Without undergoing surgery you can achieve a youthful appearance. So while stars such as Bar Rafaeli and Kim Kardashian have used platelets to enhance their appearance, the vampire facial is accessible to you and will give your skin a healthy, revitalized feeling. Everyone has an inner beauty. PRP helps your outer beauty so it is in sync with your inner beauty.

There are other cosmetic benefits to platelets. The growth factors that the platelets release can heal scars. This includes unsightly scars after a surgery or a laceration. Growing collagen within the scar will usually improve its appearance. Acne scars, which are tiny holes along the skin surface, are filled in with platelets. Burn scars may not be totally eliminated with PRP, but the growth factors can have dramatic effects on the appearance of these scars.

Another cosmetic benefit of PRP is hair growth. PRP leads to increased hair follicle formation increasing the hair density. While not practical for total hair loss, PRP is excellent for treating thinning hair in men and women. The best part is that you are stimulating the follicle growth with your own platelets without the use of medications or other invasive procedures. So if you run your hand through your hair and you feel it is thinner than you would like, PRP may be for you.

PRP is abundant, safe and the worlds most sophisticated repair system. Nothing else comes close to its amazing properties. PRP is a powerful source of growth factors. Whats best is that it comes from your own body so you are healing your own body with your own platelets. Whether you have an injury that needs the healing benefit of platelets, or if you want to enhance your appearance, promote hair growth or improve a scar, or for other challenges that can be enhanced with platelets, you should consider PRP to improve your quality of life. The success of PRP has been enhanced with the new technology of third-generation PRP. The concentrated growth factors (CGF) optimize platelets that are enhanced by stem cells for maximal benefit.

Dr. Slaten is a pain wellness physician in Ridgewood. For more than 20 years he has been practicing regenerative techniques with great skill and an open mind. Check out his website at http://www.njprp.com for more information.

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The Third Generation of PRP Is Here - Jewish Link of New Jersey

Recommendation and review posted by Bethany Smith

TWIN CITIES, Minn. (PRWEB) November 07, 2019

In response to the growing threat of Chronic Wasting Disease (CWD), and a report this year that outlined steps to address this potential health crisis, an organization promoting non-animal research has sent a detailed letter to stakeholders calling for an end to the funding and perpetuation of animal research to study the illness.

Citizens for Alternatives to Animal Research & Experimentation (CAARE) sent the letter (see here: https://tinyurl.com/yy2hvwt5 ) to a team of experts investigating CWD, including the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, the Minnesota Department of Health and to several divisions of the National Institutes of Health (NIH), which largely funds the research.

The five-page letter discusses how lengthy, expensive taxpayer funded animal experiments investigating this deadly chronic wasting disease have yielded nothing but unproductive results that put human lives at risk, while subjecting animals to prolonged and unjustifiable suffering.

CWD is a prion-related, global epidemic affecting wild deer, elk, and other cervids. It is related to Bovine Spongiform Encephalopathy (BSE, or mad cow disease) and detected in 26 US states, three Canadian provinces, Norway, Finland, Sweden and South Korea.

CAAREs letter is a strong appeal for an end to animal experiments of CWD and to instead focus future resources toward research methods that show genuine promise in generating human-relevant data.

Such experiments are already being carried out. Earlier this year, NIH developed cerebral organoids engineered from human skin cells as a promising method to study prion disease, while in 2017 research at the University of Edinburgh successfully generated human stem cell-derived astrocytes capable of replicating human prions.

CWD experiments entail significant suffering for animals, detailed in CAAREs letter. Various publications have described in detail how monkeys have had holes drilled in their skulls and infected tissue injected directly into their brains.

Other monkeys had infected steel wires implanted in their brains for years, other were exposed via blood transfusion and still others were inflicted with cuts to the skins that were wrapped in infected deer brains. Not one of these studies yielded conclusive information on the threat of transmission of CWD.

CAAREs letter emphasizes that NIHs own systematic review could only report a high level of uncertainty regarding possible transmission of CWD to humans, and urges that all scientists and public health experts effectively address the threat of CWD and its unknown transmissibility to humans by ending inconclusive animal studies and replacing them with human-centered methodologies.

All animal experiments currently conducted at the Rocky Mountain Laboratories, the Alberta Institute for Prion Research, the University of Calgary and elsewhere should be immediately terminated. In the interest of mercy and in recognition for their sacrifice to humans, we believe that all current animal survivors of CWD experiments should be sent to sanctuaries, said CAARE.

Citizens for Alternatives to Animal Research & Experimentation is a national 501(c)(3) non-profit organization, established to highlight and promote research without animals. CAAREs mission is to reduce animal suffering by disseminating information about the power and progress of research without animals.

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National Group Calls for End to Cruel and Ineffective Animal Experiments of 'Chronic Wasting Disease,' Urges Shift to Modern, Superior Methods - PR...

Recommendation and review posted by Bethany Smith

For pear butter, you'll want a variety that breaks down in cooking. Bartlett pears will do well.(Photo: Abel Uribe, TNS)

Apples may get all of autumns accolades, but its time for pears to muscle in on the action.

Understanding which pear varieties are best for which uses will help you choose wisely from the fruit youll see at farmers markets, farm stands and grocery stores.

You can eat any pear raw, from juicy Bartletts to crisp Asian pears. But in cooking, you may want the pear to retain its shape, or you may want it to melt into a concentrated sauce. I remember pear varieties that hold their shape for poached pears, and for the pear tart we offer here with a simple mnemonic of ABC: Anjou, Bosc and Comice.

Some varieties are more grainy or gritty than others but peeling any pear will help reduce that graininess. As pears ripen on the tree, they develop stone cells, and most of these lie just under the skin. Most pears are harvested before theyre fully ripe for this reason. While the skin is full of nutrients, sometimes you just want that grittiness to go away.

Like apples, cut pears will brown when exposed to air. For salads and other raw uses where appearance is important, place the pears in water acidulated with lemon juice for a quick bath to prevent browning.

These are the varieties youre likely to see this season, with a bit of information about them and their best uses.

A ripe Bartlett, the juiciest of all the pears, will leave your chin dripping when you eat it out of hand. (Terrence Antonio James/Chicago Tribune/TNS)(Photo: Terrence Antonio James, TNS)

Anjou: Firm and mild flavored, Anjous are good for cooking where you want the pear to pick up the flavors of its cooking companions. Red and green Anjous have the same flavor.

Asian: As crisp as a ripe apple, Asian pears are very mild in flavor. Theyre the outlier in the pear family, more apple than pear.

Bartlett: The juiciest of all the pears, a ripe Bartlett will leave your chin dripping when you eat it out of hand. Choose red or green Bartletts when you want the fruit to cook into a sauce, as we do in the vanilla-cardamom pear butter recipe here.

Bosc: Crisp and mildly sweet, Boscs are the classic choice for poached pears. Theyre easy to recognize because of their cinnamon-colored russeted skin. They tend to be a nice size as well.

Comice: Brightly flavored with the quintessential pear taste, Comice pears are less grainy than many other varieties.

Concorde: A favorite in Europe, the Concorde has a long neck that makes it immediately identifiable. Its distinctively vanilla flavor makes it a favorite for roasting and grilling, but its also great out of hand.

Forelle: A pretty speckled pear thats popular in Europe, this small pear is best for snacking. Its name comes from the German word for trout, because its colors echo the flashing brilliance of the fish. Grown in small quantities in the Pacific Northwest, Forelle tells you its ripe when the skin under its red speckles turns from green to yellow.

French butter: Small with concentrated flavors, make sure French butter pears are fully ripe before use. Underripe fruit has a sharp, tannic flavor. Good for snacking, or in salads.

Seckel: Just as with French butter pears, make sure the little Seckel pears are fully ripe before eating to avoid a tannic hit. Best out of hand, or in salads.

Robin Mather is a longtime food journalist and the author of The Feast Nearby, a collection of essays and recipes from a year of eating locally on a budget. Follow her as she writes her third book at thefeastofthedove.com.

A pastry shell of ground almond meal, butter and sugar holds a pastry cream and poached pears. Sliced almonds finish off the dessert. (Terrence Antonio James/Chicago Tribune/TNS)(Photo: Terrence Antonio James, TNS)

PEAR-ALMOND TART

This simple tart will look and taste more impressive than its simple ingredients might suggest. Remember that you want pears that will hold their shape for this tart. If you cant find creme fraiche, substitute lightly sweetened sour cream as a garnish at serving time.

Prep: 30 minutes

Cook: 40 minutes

Makes: about 12 servings

Crust:

2 1/4 cups ground almond meal

4 1/2 tablespoons sugar

8 tablespoons melted salted butter

Filling:

2 cups sugar, divided use (plus more for browning)

3 Anjou, Bosc or Comice pears, peeled, sliced in half

1 1/2 cups milk

2 teaspoons vanilla

3 eggs, lightly beaten

1/4 cup flour

1/4 cup sliced toasted almonds

Creme fraiche, sweetened sour cream or whipped cream

1. For the crust: Heat the oven to 350 degrees. Combine almond meal, sugar and melted butter in a medium bowl. Stir to combine. Pat the crust mixture into the bottom and up the sides of a 12-inch tart pan and press into place with the bottom of a drinking glass. Bake the crust until just colored, 10 to 15 minutes. Remove and allow to cool completely before filling.

2. For the filling: Heat 4 cups water and 1 1/2 cups sugar to a boil in a large saucepan over medium-high heat. Reduce heat to low. Add the pears; poach until tender, 20-25 minutes. Remove pears from the syrup. Allow to cool, then cut out cores. Cut the pears into fans by slicing into 1/4-inch slices that remain attached by about 1/2 inch at the stem end. Set aside.

3. Combine milk and vanilla in a small saucepan and bring it to just a simmer over medium heat. (Dont let it boil over.) Combine eggs, remaining 1/2 cup sugar and the flour in a large saucepan. Temper the mixture by slowly whisking in a little of the hot milk. Then gradually whisk in the rest. Cook, whisking continuously, over medium heat. At the first sign of a boil, 3 to 6 minutes, remove pan from the heat while continuing to whisk until mixture begins to thicken. Allow the custard to cool.

4. Spoon cooled custard into the tart shell. Lay the fanned-out pears, stem end inward, in the custard. Scatter the sliced almonds over top. Sprinkle with 1 to 2 tablespoons sugar. Heat the broiler in the oven. Place the tart on the middle rack, 4 to 5 inches from the broil. Allow to broil until pears and custard are golden, about 5 minutes, watching carefully.

5. Serve warm with creme fraiche, sweetened sour cream or whipped cream.

Nutrition information per serving: 428 calories, 22 g fat, 7 g saturated fat, 69 mg cholesterol, 54 g carbohydrates, 45 g sugar, 8 g protein, 101 mg sodium, 4 g fiber

VANILLA-CARDAMOM PEAR BUTTER

Prep: 35 minutes

Cook: 8-10 hours

Makes: about 7 half-pints

Youll definitely want to use ripe Bartlett pears for this fruit butter because they cook into a silky puree. Making this pear butter in the slow cooker means you dont have to stand over it while it cooks. Weve given directions to both can and freeze this sumptuous delight.

6 1/2 pounds Bartlett pears, peeled, cored and cut into 1/2-inch cubes

Juice of 1 large lemon

1/2 cup sugar

1/4 teaspoon coarse salt

2 teaspoons vanilla

1 teaspoon ground cardamom

4 tablespoons unsalted butter

1. Tumble all ingredients except butter into a slow cooker. Stir to blend, then cover and cook on low until the pear butter is very thick and mounds on a spoon, 8 to 10 hours. Test its readiness by placing a spoonful on a plate; if no liquid escapes around the edges, the pear butter is ready. If it weeps, continue to cook with the lid crosswise to allow excess liquid to evaporate.

2. Stir in the butter until it is fully melted. Ladle the hot pear butter into sterile half-pint jars, leaving 1/4-inch headspace. To can, apply lids and rings just until finger tight; process in a boiling water bath for 10 minutes. To freeze, allow the pear butter to cool to room temperature, then freeze without lids. Once pear butter is frozen, add lids and freeze for up to six months.

Nutrition information per tablespoon: 21 calories, 0 g fat, 0 g saturated fat, 0 mg cholesterol, 5 g carbohydrates, 3 g sugar, 0 g protein, 5 mg sodium, 1 g fiber

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What pears to pick for your fall recipes starting with a pear tart and pear butter - The Detroit News

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Arizona has been called "the wild, wild west" of regenerative medicine.

The Valley is one of the most popular places in the country for stem cell clinics. The new and controversial therapy is being marketed and practiced all over Phoenix and Scottsdale.

The less invasive procedure promises to heal pain, nearly anywhere in their body. It is advertised as effective, safe, and ethical, but outside experts and industry insiders say consumers need to do their research to avoid being exploited, and potentially spending thousands in cash on a worthless injection.

"IT HAS GREAT POTENTIAL"

The world of regenerative medicine is still being explored and developed.

"It actually gives you really good results," explained Dr. Matthew Hernandez, a naturopathic physician with Ethos.

"There's a lot of hope and promise, generally around the prospects for stem cells," said ASU Professor Emma Frow.

"Were still in the developmental stage. Stem cell therapy has been around for less than ten years. Thats new in medicine," said Dr. Steven Sorr, a naturopathic physician who runs Source of Health in Scottsdale.

"It encourages your own body to heal itself," said Janet McConnell, a 63-year-old bodybuilder who "had cartilage damage several years ago."

Instead of a surgery that would have derailed her competition training for months, she opted for injections.

"Three years ago, instead of the surgery, I had a PRP treatment," said McConnell. "It was very effective."

Years later, she returned to Dr. Hernandez for another round.

For most, Stem Cell and Platelet Rich Plasma (PRP) therapy is a mystery. "It's kind of controversial and experimental," said Matthew Riddle, Director of Sales for Celling Biosciences.

The treatments concentrate platelets or stem cells, usually from the patient's own blood. Experts say it is important to always ask the doctor or provider where the "growth factors" are coming from, because in order to ensure they are alive they should be coming from the patient's own blood, fat, or bone marrow. Otherwise, patients can receive "dead" stem cells, which are not nearly as effective.

"We are very adamant to use the patient's own cells," said Riddle, who uses a centrifuge to separate out the blood, saline and growth factors that will be re-injected. "When we inject that into an area, we are telling your body to go heal that spot," said Dr. Hernandez.

"Stem cell treatment is really about trying to take the stem cells out of your body and...inject them back into another part of your body, in order to try and heal whatever part of the body is suffering," said Professor Frow.

"IT'S THE NEW WAVE"

According to researchers, Scottsdale and Phoenix are two of the seven "hot spot" cities in the country.

Arizona State University professors Emma Frow and Dave Brafman spent years studying the industry , and mapping out dozens of clinics in the Valley. They believe there are many more, as some intentionally practice under the radar. "I don't believe right now that there is enough evidence to suggest that they work," said Professor Frow.

"They are unregulated, unproven and for-profit," added Professor Brafman.

The profits are plentiful. "There's cash involved, so this isn't covered by insurance," said Dr. Hernandez.

"PREYING ON PEOPLE'S PAIN"

The thousands in cash is one of many reasons the burgeoning industry is ripe for exploitation.

"The other piece too, it is it is new and upcoming," said Dr. Hernandez.

Many potential patients do not know the first thing about the procedure they are being sold, and doctors say many fall for sales tactics that are practiced at traveling seminars.

"They are preying on people's pain," said Dr. Sorr. "I think its really unethical and it upsets me."

Dr. Sorr believes the seminars are "a scam" that specifically targets an elderly clientele.

"They wine you and dine you. They go through a little dinner presentation and it is not the doctor, it's a marketing agency," he said.

The doctor told ABC15 he has had clients who have been duped, even after he told them they were not ideal candidates for stem cell or PRP therapy.

"It really broke my heart that he spent thousands upon thousands of dollars for something that was worthless.

"I don't agree with how they are done," said Dr. Hernandez. "They inject people and they get money. That's not practicing medicine, that is selling."

Both naturopathic physicians told ABC15 that some patients do not need the treatment, or will get subpar results from the injections. They say it is well known in the industry that some practices will continue to sell in order to reap the thousands in cash.

"ALL OF IT FALLS ON THE PATIENT"

Right now, there is little regulation or oversight of the industry in Arizona.

"Really all of it the falls on the patient, with very little recourse if things go wrong," said Dr. Emma Frow.

During the course of our investigation, ABC15 discovered the Arizona Medical Board and County Health Department do not take complaints or oversee the people performing injections. The federal government has also been slow to implement widespread regulation.

"The FDA has their hands tied," said Dr. Sorr. "There are too many people out there that are doing this that havent had the proper training, they dont have the right experience, the right tools and all that."

There are some larger regulations in Arizona, governing who can handle a needle and perform injections.

Unlike other industries though, including massage therapy, there is no board that checks on licensing or investigates complaints involving botched procedures or alleged fraud.

"The state medical boards, need to become a little bit more involved in sort of identifying, or responding to claims," said Professor Brafman.

"I don't think it would hurt to have it, for sure. At the end of the day it's about protecting the public," said Dr. Hernandez.

For thousands of Arizonans, like Janet McConnell, regenerative medicine has helped heal chronic pain. Before spending thousands thousands though, do your research. "Always get a second opinion," said Dr. Sorr.

"I think this is really a case of buyer beware, or consumer beware," said Professor Frow.

If you are planning on undergoing a stem cell or PRP treatment, click here for questions experts say you should always ask ahead of time.

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Arizona the "wild west" of stem cell therapy; experts say promising therapy ripe for exploitation - ABC15 Arizona

Recommendation and review posted by Bethany Smith

A potentially life shattering diagnosis turned into motivation to help others. A Peoria woman is hosting a Be the Match event at the Greater Peoria YMCA on Wednesday.

While many might say Why me? when diagnosed with a rare bone marrow cancer, Marsha Krone continued to fight on, choosing to make the most of the life she has been given.

A mother of three, grandmother of two, lover of sewing, and teacher for over 30 years, Marsha Krone had a lot to smile about. Until an existing blood disorder threatened to steal her joy.

I went to the Mayo Clinic and they did a bone marrow biopsy and they told me that yes, you have progressed to Myelofibrosis. And so what that means is my bone marrow is essentially turning hard. said Marsha Krone, diagnosed in 2016

Krone needs a stem cell transplant. Her sisters were not a match.Despite millions of donors being listed on the registry she is still waiting for the perfect stranger. However of the ten markers needed to match, two are extremely rare, making it difficult, but not impossible to find one.

Her hope comes from faith.

I cant write my story because he writes my story and I just can choose how Im going to live it. So I choose joy. said Krone

As an ambassador for Be the Match she has put on numerous events, including the one coming up at the Greater Peoria YMCA where shes been a member for many years.

We talked about how could we help in this way and she said well lets hold a match event and try to get as many people engaged as we possibly can. Shes not doing this for herself, shes doing this for everyone out there that needs to find a match said President and CEO of the Greater Peoria YMCA, Andy Thornton

The process is simple. You swab your cheek for DNA, provide your contact information, and join the registry where you could match anyone in the world for stem cells and bone marrow.

If someone else was matched from a drive we promoted, that would be really exciting for me to know that I was the go between to helping someones life be saved. said Krone.

The event takes place Wednesday 11/6 from 3 7 P.M. at The Greater Peoria YMCA

Link:
Using her diagnosis to help others, Peoria woman to host 'Be the Match' event - week.com

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ("Takeda") today announced the randomized, Phase 3 TOURMALINE-MM4 study met its primary endpoint of progression free survival (PFS). The trial evaluated the effect of single-agent oral NINLARO (ixazomib) as a first line maintenance therapy versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation. TOURMALINE-MM4 is the first industry sponsored Phase 3 trial to explore the concept of switch maintenance, the use of medicines not included in initial induction therapy, in this setting. NINLARO is currently not approved for this specific use.

We are very encouraged by the results of the TOURMALINE-MM4 trial and continue our forward momentum in developing maintenance options for multiple myeloma patients. Importantly, this is the third positive Phase 3 readout from the TOURMALINE clinical trial program, said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. We remain committed to bringing this convenient and well-tolerated treatment option to patients.

The safety profile of NINLARO in the maintenance setting was consistent with previously reported results of single-agent NINLARO use, and there were no new safety signals identified in TOURMALINE-MM4.

Full data results will be submitted for presentation at an upcoming medical meeting.

About the TOURMALINE-MM4 Trial

TOURMALINE-MM4 is a randomized, placebo-controlled, double-blind Phase 3 study of 706 patients, designed to determine the effect of single-agent oral NINLAROTM (ixazomib) maintenance therapy on progression-free survival (PFS), compared to placebo, in adult patients newly diagnosed with multiple myeloma not treated with stem cell transplantation, who have completed 6-12 months of initial therapy and achieved a partial response or better. For additional information, please visit https://clinicaltrials.gov/ct2/show/NCT02312258.

About Multiple Myeloma

Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission. Nearly 230,000 people around the world live with multiple myeloma, with approximately 114,000 new cases diagnosed globally each year.

About NINLAROTM (ixazomib) capsules

NINLARO (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings. NINLARO was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is currently approved in more than 60 countries, including the United States, Japan and in the European Union, with more than 10 regulatory filings currently under review. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval.

The comprehensive ixazomib clinical development program, TOURMALINE, includes several ongoing pivotal trials, which together are investigating major multiple myeloma patient populations:

In addition to the TOURMALINE program, ixazomib is being evaluated in multiple therapeutic combinations for various patient populations in investigator initiated studies globally.

NINLAROTM (ixazomib) capsules: Global Important Safety Information

SPECIAL WARNINGS AND PRECAUTIONSThrombocytopenia has been reported with NINLARO (28% vs. 14% in the NINLARO and placebo regimens, respectively) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. It did not result in an increase in hemorrhagic events or platelet transfusions. Monitor platelet counts at least monthly during treatment with NINLARO and consider more frequent monitoring during the first three cycles. Manage with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal toxicities have been reported in the NINLARO and placebo regimens respectively, such as diarrhea (42% vs. 36%), constipation (34% vs. 25%), nausea (26% vs. 21%), and vomiting (22% vs. 11%), occasionally requiring use of antiemetic and anti-diarrheal medications, and supportive care.

Peripheral neuropathy was reported with NINLARO (28% vs. 21% in the NINLARO and placebo regimens, respectively). The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

Peripheral edema was reported with NINLARO (25% vs. 18% in the NINLARO and placebo regimens, respectively). Evaluate patients for underlying causes and provide supportive care, as necessary. Adjust the dose of dexamethasone per its prescribing information or the dose of NINLARO for severe symptoms.

Cutaneous reactions occurred in 19% of patients in the NINLARO regimen compared to 11% of patients in the placebo regimen. The most common type of rash reported in both regimens was maculo-papular and macular rash. Manage rash with supportive care, dose modification or discontinuation.

Hepatotoxicity, drug-induced liver injury, hepatocellular injury, hepatic steatosis, and hepatitis cholestatic have been uncommonly reported with NINLARO. Monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms.

Pregnancy- NINLARO can cause fetal harm. Advise male and female patients of reproductive potential to use contraceptive measures during treatment and for an additional 90 days after the final dose of NINLARO. Women of childbearing potential should avoid becoming pregnant while taking NINLARO due to potential hazard to the fetus. Women using hormonal contraceptives should use an additional barrier method of contraception.

Lactation- It is not known whether NINLARO or its metabolites are excreted in human milk. There could be potential adverse events in nursing infants and therefore breastfeeding should be discontinued.

SPECIAL PATIENT POPULATIONSHepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. NINLARO is not dialyzable and, therefore, can be administered without regard to the timing of dialysis.

DRUG INTERACTIONSCo-administration of strong CYP3A inducers with NINLARO is not recommended.

ADVERSE REACTIONSThe most frequently reported adverse reactions ( 20%) in the NINLARO regimen, and greater than in the placebo regimen, were diarrhea (42% vs. 36%), constipation (34% vs. 25%), thrombocytopenia (28% vs. 14%), peripheral neuropathy (28% vs. 21%), nausea (26% vs. 21%), peripheral edema (25% vs. 18%), vomiting (22% vs. 11%), and back pain (21% vs. 16%). Serious adverse reactions reported in 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in 1% of patients in the NINLARO regimen.

For European Union Summary of Product Characteristics: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003844/WC500217620.pdf For US Prescribing Information: https://www.ninlarohcp.com/pdf/prescribing-information.pdf For Canada Product Monograph: http://www.takedacanada.com/ninlaropm

About Takeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

Important NoticeFor the purposes of this notice, press release means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (Takeda) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, Takeda is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words we, us and our are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking StatementsThis press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takedas future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as targets, plans, believes, hopes, continues, expects, aims, intends, ensures, will, may, should, would, could anticipates, estimates, projects or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takedas estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takedas global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takedas operations and the timing of any such divestment(s), any of which may cause Takedas actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takedas results, performance, achievements, or financial position, see Item 3. Key InformationD. Risk Factors in Takedas most recent Annual Report on Form 20-F and Takedas other reports filed with the U.S. Securities and Exchange Commission, available on Takedas website at: https://www.takeda.com/investors/reports/sec-filings/ or at http://www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takedas future results.

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Phase 3 Trial of NINLAROTM (ixazomib) as First Line Maintenance Therapy Met Primary Endpoint in Multiple Myeloma Patients not treated with Stem Cell...

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NEW YORK, Nov. 05, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2019, and provide a corporate update, at 8:00 a.m., Eastern Standard Time, on Thursday, November 14, 2019.

BrainStorms President & CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com; Questions should be submitted by 5:00 p.m., Eastern Standard Time, Tuesday, November 12.

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the Investors & Media page of BrainStorms website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwnNurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Cell Therapeutics to Announce Third Quarter Financial Results and Provide a Comprehensive Corporate Update - Yahoo Finance

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