Highly contagious coronavirus variant's mutation weakens antibody effectiveness

 FIU researchers looking to unravel the secrets of how the coronavirus' most contagious variant became so widespread have found an intriguing clue.

Computer modeling allowed researchers to see how mutations in a certain area of the delta variant may prevent antibodies from fully latching on to the virus. These antibodies—resulting from vaccination or from fighting a COVID-19 infection—help our immune system by interrupting or slowing the coronavirus at various steps in its process to invade a human cell and multiply.

The subtle structural changes could help explain why the delta variant is so contagious.

The discovery was made by a team of researchers led by Prem Chapagain, a physicist who is associate director of FIU's Biomolecular Sciences Institute, and computer sciences professor Giri Narasimhan of the Knight Foundation School of Computing and Information Sciences in FIU's College of Engineering and Computing. Their study was published in the journal Biochemical and Biophysical Research Communications.

"The delta variant seems to have found an immune escape," Narasimhan said. "By mutating a little bit, it has weakened the impact of the antibody."

Because the structural changes due to mutation occurred mostly in one region of the binding interface, there are still plenty of other parts of the virus where antibodies can latch on and prevent the virus from working as intended. It's why vaccines are still effective against the virus.

"Viruses don't make the changes knowingly," Chapagain said. "Occasionally, they find something that will work better for them, and those variants will be more prevalent."

Even the delta variant itself continues to mutate, which is why computer modeling efforts like those being undertaken at FIU could be the key to quickly understanding how future variants behave or stopping future pandemics in their tracks. The computational team led by Narasimhan is leveraging funding from the National Science Foundation to train computers that could one day predict how proteins from antibodies and viruses will interact.

For now, both Chapagain and Narasimhan encourage people to get vaccinated and to wear masks to curb the spread of the coronavirus and any future variants that might spread next.

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More information: Prabin Baral et al, Mutation-induced changes in the receptor-binding interface of the SARS-CoV-2 Delta variant B.1.617.2 and implications for immune evasion, Biochemical and Biophysical Research Communications (2021). DOI: 10.1016/j.bbrc.2021.08.036

https://medicalxpress.com/news/2021-09-highly-contagious-coronavirus-variant-mutation.html

Surfing doctor finds simple life-saving shark bite treatment

 How do you help someone with their leg bitten off by a shark? Groundbreaking research by an Australian medic-surfer has uncovered a simple way to stop bleeding and save lives.

Find the middle point between the hip and the genitals, make a fist and push as hard as you can.

Shark attacks are rare but on the increase Down Under, due in large part to more people being in the water.

So surfer and Australian National University medical school dean Nicholas Taylor set out to discover how to reduce fatalities in the event of an attack.

Many fatal shark bites occur around the legs, leaving the victim to bleed to death despite making it back to shore.

In a study published by Emergency Medicine Australasia, Taylor found that a simple technique to compress the femoral artery was much more effective in stopping bleeding than traditionally-used tourniquets.

His study showed that by making a fist and pressing down on the artery around 89.7% of blood flow was stopped, versus 43.8% using a surfboard leash as a make-shift tourniquet.

The technique worked equally well with the patient wearing a wetsuit and without.

"I knew from my background in emergency medicine if people have massive bleeding from their leg, you can push very hard on the femoral artery and you can pretty much cut the entire blood flow of the leg that way," he said in a statement released by the university on Friday.

"It is easy to do and easy to remember—push hard between the hip and the bits and you could save a life."

Taylor hopes the technique will become widely known among Australia's roughly half a million surfers, for whom shark encounters are less uncommon.

"I want posters at beaches. I want to get it out in the surf community. I want people to know that if someone gets bitten you can pull out the patient, push as hard as you can in this midpoint spot and it can stop almost all of the blood flow," he said.

https://medicalxpress.com/news/2021-09-surfing-doctor-simple-life-saving-shark.html

New potential factor contributing to severity of COVID-19 identified

 The University of Kent's School of Biosciences and the Institute of Medical Virology at Goethe-University, Frankfurt am Main, have identified a protein that may critically contribute to severe forms of COVID-19.

SARS-CoV-2 is the coronavirus that causes COVID-19. While many individuals develop only mild or no symptoms upon SARS-CoV-2 infection, others develop severe, life-threatening disease.

Researchers have found that the infection of cells with SARS-CoV-2 results in increased levels of a protein called CD47 on the cell surface.

CD47 is a so-called 'do not eat me' signal to the immune system's defenses that protect cells from being destroyed. Virus-induced CD47 on the surface of infected cells is likely to protect them from immune system recognition, enabling the production of larger amounts of virus, resulting in more severe disease.

Well-known risk factors for severe COVID-19 such as older age and diabetes are associated with higher CD47 levels. High CD47 levels also contribute to high blood pressure, which is a large risk factor for COVID-19 complications such as heart attack, stroke, and kidney disease.

The data suggest that age and virus-induced high CD47 levels contribute to severe COVID-19 by preventing an effective immune response and increasing disease-associated tissue and organ damage.

Since therapeutics targeting CD47 are in development, this discovery may result in improved COVID-19 therapies.

Professor Martin Michaelis, University of Kent, says that "this is exciting. We may have identified a major factor associated with severe COVID-19. This is a huge step in combatting the disease and we can now look forward to further progress in the design of therapeutics."

Professor Jindrich Cinatl, Goethe-University Frankfurt, says that "these additional insights into the disease processes underlying COVID-19 may help us to design better therapies, as well as appreciation for the importance of the breadth of research being conducted. Through this avenue, we have achieved a major breakthrough and exemplified that the fight against the disease continues."

The study is published by the scientific journal Current Issues in Molecular Biology.

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More information: Katie-May McLaughlin et al, A Potential Role of the CD47/SIRPalpha Axis in COVID-19 Pathogenesis, Current Issues in Molecular Biology (2021). DOI: 10.3390/cimb43030086

https://medicalxpress.com/news/2021-09-potential-factor-contributing-severity-covid-.html

3,000 NYC Teachers Asked For Vaccination Exemptions: Union

 By Peter Svab of Epoch Times,

Around 3,000 New York City teachers have asked for medical and religious exemptions from the city’s COVID-19 vaccination mandate, according to the city’s teachers union.

The city requires all school staff to be vaccinated or exempted by midnight on Sept. 27. The union, United Federation of Teachers (UFT) said on Sept. 24 that 90-95 percent of teachers have received the vaccine. That would leave about 4,000-8,000 unvaccinated, including those who have asked for the exemption.

The exemptions are largely medical, UFT President Michael Mulgrew told reporters during a Sept. 24 teleconference. He didn’t specify how many have been granted. Those rejected have an option to appeal, but Mulgrew said he didn’t know how many have done so.

With a pending appeal, a teacher can’t participate in instruction, but gets exempted from the mandate, which requires those unvaccinated after the deadline to either leave their jobs with a severance package or take unpaid leave.

Given the city’s total of some 78,000 teachers, about 4 percent have asked for exemptions.

Both Mulgrew and Mark Cannizzaro, president of the Council of School Supervisors and Administrators, warned that the mandate deadline could cause staffing shortages, despite the city’s assurances that there will be enough substitutes.

“Principals and superintendents have been reaching out consistently to tell us that they are concerned about not having enough staff come Tuesday morning,” Cannizzaro said during the teleconference.

The blamed the city administration for a lack of advanced planning and suggested the city should allow unvaccinated staffers to still come to work for as long as it’s needed to resolve staffing issues at their individual schools.

“Until there’s a plan to make sure schools are safe, we need to reevaluate what we’re doing going forward,” Cannizzaro said.

They also criticized the city for putting the deadline on Monday, leaving schools in a position where they may learn on Monday night, they need a substitute for somebody the following morning.

“Who’s the genius who decided to do it on a Monday by midnight?” Mulgrew said.

Cannizzaro suggested a better way would have been to place the deadline before the start of the school year, before a holiday, or before a long weekend.

“Perhaps we would have had enough time to make contingency plans to be ready to welcome students,” he said.

The municipal workers union has been fighting the mandate in court and initially managed to get it put on hold. But the court lifted the restraining order on Sept. 23.

“This case has already led to progress in protecting the rights of our members, since the city—in the wake of the court’s initial issuance of the restraining order—admitted that there can be exceptions to the vaccine mandate,” Municipal Labor Committee Chair Harry Nespoli said in a Sept. 22 statement.

“The court—while lifting the restraining order—has not made a final decision, and we are preparing additional material to support our case.”

The city explained the mandate as a way to reduce risk posed by the CCP (Chinese Communist Party) virus, which causes COVID-19, as well as to prevent school closures due to outbreaks. It imposed a slew of other restrictions including mandatory masks for both students and staff, 3-foot distancing between students when possible, and biweekly random testing (among students whose parents consented). The testing frequency was increased to weekly upon UFT’s request. Based on the rules, one student testing positive could lead to the whole class being relegated to remote learning for 7-10 days, regardless of whether the others test positive of not. Schools have also nixed supposedly riskier activities such as indoor eating and extracurriculars like choir, band, and sports.

Many have opposed the rules, questioning why children, who are at low risk of getting serious symptoms from COVID-19, are being forced to wear masks all day while celebrities and politicians have been seen attending numerous events maskless.

https://www.zerohedge.com/markets/3000-nyc-teachers-asked-vaccination-exemptions-union-says

Out-of-pocket spending on dental, hearing in Medicare far outweighs vision benefits: Kaiser

 Out-of-pocket spending for hearing and dental care far outpaced spending for vision care among Medicare beneficiaries, a new analysis found.

The analysis, released Tuesday by the Kaiser Family Foundation, examines out-of-pocket spending in 2018 and 2019 on traditional Medicare and Medicare Advantage on the three benefits. It comes as Congress is contemplating adding the three benefits to traditional Medicare as part of a $3.5 trillion infrastructure package.

“While some Medicare beneficiaries have insurance that helps cover some dental, hearing, and vision expenses (such as Medicare Advantage plans), the scope of that coverage is often limited, leading many on Medicare to pay out-of-pocket or forego the help they need due to costs,” Kaiser said in the analysis.

The largest source of out-of-pocket spending was hearing care, where beneficiaries spent $914 on average in 2018, Kaiser found.

Out-of-pocket spending on dental was $874, and vision care was $230.

But dental care was by far the most used benefit, with 53% of Medicare’s beneficiaries employing it. Vision care was the second most-used benefit with 35% of beneficiaries employing the service, and hearing care was used by 8%.

Kaiser found that in 2018, a small share of beneficiaries incurred the highest out-of-pocket costs for dental and hearing care.

Half of the beneficiaries that got dental services had out-of-pocket spending below $244 in 2018 as well as $130 for vision and $60 for hearing benefits.

But a smaller share of beneficiaries incurred high out-of-pocket costs. Kaiser found that beneficiaries in the top 10% of out-of-pocket costs spent $2,136 or more for dental care, $3,600 for hearing and $585 for vision care.

The higher costs were likely tied to costly equipment like hearing aids or pricey dental procedures such as implants, Kaiser said.

Overall, beneficiaries enrolled in MA plans spent less out-of-pocket for dental and vision than traditional beneficiaries, but there was no difference in spending on hearing care.

“Both groups spent substantially more for dental and hearing services than vision services,” the analysis said. “For dental services, average out-of-pocket spending was $766 among beneficiaries in Medicare Advantage and $992 among beneficiaries in traditional Medicare.”

The analysis also found problems with some beneficiaries getting access to care.

“About one in six Medicare beneficiaries reported in 2019 that there was a time in the last year that they could not get dental, hearing or vision care, and among those who reported access problems, cost was a major barrier,” Kaiser said.

The analysis comes as Congress is debating how to add dental, vision and hearing benefits to traditional Medicare as part of a $3.5 trillion infrastructure package.

“Expanding Medicare coverage for dental, hearing and vision services and making lower-cost hearing aids available would address significant gaps in coverage and could alleviate cost concerns related to these services for people on Medicare,” Kaiser’s analysis said.

https://www.fiercehealthcare.com/payer/kff-analysis-finds-out-pocket-spending-dental-vision-medicare-far-outweighs-vision-benefits

CytoDyn Holders Share Plan to Obtain Cancer Therapy OK for Leronlimab

 Plan Designed to Generate Much-Needed Revenue and Receive FDA Approval for Currently Mismanaged Drug

Believes Company Cannot Continue to Pursue Status Quo Strategy, Which Has Been Abjectly Discredited

 

A group of long-time stockholders (the “Nominating Stockholders” or the “Group”) of CytoDyn Inc. (“CYDY or the “Company”) (OTC: CYDY) that has nominated five highly experienced director candidates to serve on the Company’s Board of Directors today announced its comprehensive strategic plan to obtain cancer therapy approval for Leronlimab. If implemented, the Group believes this plan would begin to generate much-needed revenue for CYDY and position the Company to earn FDA approval for the drug, while enhancing the value of all stockholders’ shares.

The Group’s strategy is designed to overcome current CYDY management’s failures to implement a coherent, effective plan to generate revenue and obtain FDA approval for Leronlimab. While the Group has tried to discuss the enormous potential of its oncological strategy to reinvigorate CYDY with the Board and management team, they have refused to meaningfully engage every step of the way. Instead, incumbent Company leadership has decided to focus on entrenching themselves and clinging to their outsized compensation packages at the expense of shareholders.

The Group’s approach to cancer therapy will be scientifically valid and extremely efficient and will be critical to unleashing the potential value of Leronlimab and the investments of all stockholders. The full plan can be found here, and highlights are as follows:

• Utilize real data based on precision medicine determination of Leronlimab binding cancers;
• Apply both combination therapy with complementary immune-oncology blockbuster drugs and adjuvant monotherapy in CCR5+ tumors;
• Prioritize cancer targets based on CCR5 expression; and
• Partner with leading oncology companies that lack a CCR5 asset like Leronlimab.

Dr. Bruce Patterson, one of the Group’s five nominees and a renowned virologist, pathologist, and cancer technology pioneer, stated: “We are excited to present our plan on how to maximize the value of Leronlimab and save the lives of countless cancer patients. We believe we have put in place a strategy that is not only executable but also best positions CYDY for future success and will repair the Company’s standing among the medical, regulatory, and investment communities. In order to protect the value of your investment in CYDY, we strongly you recommend you for our highly qualified director nominees on the WHITE proxy card today.”

Dr. Patterson added, “Immuno-oncology (IO) has revolutionized oncological therapy for many cancers and makes up one of the largest cancer drug market segments. However, CYDY’s Board and management have utterly failed to capitalize on this tremendous opportunity and have not publicly presented any strategic plan on how they might make Leronlimab a reality. On the other hand, our cancer program will combine the value that Leronlimab has as a potential adjuvant therapy following treatment with the urgent opportunities that exist in IO and in doing so, will create enormous value for CYDY and its stockholders. This carefully designed plan is critical to the Company’s success, and we are excited by the prospect of finally being able to implement it.”

The full text of the Group’s cancer therapy approval plan can be accessed at: www.advancingll.com/cancerplan

All CYDY shareholders are reminded that your vote is essential to charting a course towards lasting value creation and holding the current Board and management team accountable for the immense value destruction they have overseen throughout their tenure. Help us enable CYDY to achieve its incredible potential by voting the WHITE proxy card to elect the Group’s five independent director nominees today.

Important Information

Paul Rosenbaum, Jeffrey Beaty, Arthur Wilmes, Thomas Errico, M.D., Bruce Patterson, M.D., Peter Staats, M.D., Melissa Yeager and CCTV Proxy Group, LLC (collectively the “Participants”) have filed a definitive proxy statement and accompanying WHITE proxy card with the Securities and Exchange Commission (the “SEC”) to be used in connection with the solicitation of proxies from the stockholders of CytoDyn Inc. (the “Company”). All stockholders are advised to read the definitive proxy statement and other documents related to the solicitation of proxies. The definitive proxy statement and an accompanying proxy card is available at no charge on the SEC’s website at http://www.sec.gov/. In addition, the Participants will provide copies of the proxy statement, without charge, upon request. Requests for copies should be directed to the Participants’ Proxy Solicitor, Okapi Partners LLC, by calling (844) 202-7428.

Disclaimer

This material does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein in any jurisdiction to any person. In addition, the discussions and opinions in this press release and the material contained herein are for general information only and are not intended to provide investment advice. All statements contained in this press release that are not clearly historical in nature or that depend on future events are “forward-looking statements,” which are not guarantees of future performance or results, and the words “anticipate,” “believe,” “expect,” “may,” “could,” and similar expressions are generally intended to identify forward-looking statements. Forward looking statements contained in this release are based on current expectations, speak only as of the date of this press release and involve risks that may cause the actual results to be materially different. Certain information included in this material is based on data obtained from sources considered to be reliable. No representation is made with respect to the accuracy or completeness of such data. The Participants disclaim any obligation to update the information herein and reserve the right to change any of their opinions expressed herein at any time as it deems appropriate.

https://www.biospace.com/article/releases/group-of-cytodyn-stockholders-shares-strategic-plan-to-obtain-cancer-therapy-approval-for-leronlimab/

Amarin Slashes More than 50% of Sales Force in Digital Marketing Approach

 Irish-American biopharmaceutical firm Amarin this week announced a new marketing strategy for its VASCEPA drug in the U.S., starting with reducing its sales rep numbers by over 50%.

There are roughly 750 sales representatives for Amarin at present, which the company intends to whittle down to 300 as it adopts a more digital approach to marketing. In a statement, Amarin president and chief executive officer Karim Mikhail said that this move's goal is to maximize the impact of VASCEPA/VAZKEPA (icosapent ethyl) in the U.S. at a time when physicians are preferring to engage more with patients via virtual means. 

"Amarin is embarking on a transformation to a new, integrated Go-to-Market approach in the U.S., furthering our mission of helping millions of untreated, at-risk patients gain access to VASCEPA. We are seeing a dramatic shift in how physicians prefer to engage and are applying key learnings from our European launch initiatives as we work to maximize our impact with both healthcare professionals and patients. With this new strategy, we are confident in our ability to drive U.S. growth and realize the full potential of our first-of-its kind product as we continue to execute our global strategic plan to create value for all shareholders," said Mikhail. 

Cardiovascular disease remains the number one cause of death worldwide, logging some 859,000 deaths per year in the U.S. alone. In addition, there are 605,000 new and 200,000 recurrent heart attacks yearly (or one in every 40 seconds), while stroke rates are at around one every 40 seconds. Overall, there are over 2.4 million major adverse heart-related events per year or, on average, one in every 13 seconds. 

The new approach will target a greater number of statin prescribers (almost 700,000) through high-frequency, tailored, and impactful messaging on the drug's benefits in reducing cardiovascular risk. By removing barriers to VASCEPA prescriptions and preventing the improper generic substitution for this indication, patients in need of immediate therapy will be able to access the drug more easily. 

At present, several large commercial and Medicare Part D payers are already covering the drug as the exclusive icosapent ethyl (IPE) product because it is cost-effective. Today, VASCEPA is the only available Food and Drug Administration-approved IPE medication for CV risk reduction. 

VASCEPA was launched in the U.S. in January 2020 and has since been prescribed over 10 million times. It is covered by most major medical insurance plans. Aside from the U.S., it is sold in Canada, Lebanon, and the United Arab Emirates. It was also granted marketing authorization in Europe in March this year, under the brand name VAZKEPA, and will be commercially launched in Germany this month. 

https://www.biospace.com/article/amarin-slashes-50-percent-of-sales-force-as-marketing-for-cvd-drug-goes-digital/