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CytoDyn to Present at Wall Street Reporter’s Livestream Event on Tuesday, June 2, at 12:30 pm EDT / 9:30 am PDT

On June 1, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, Jacob Lalezari, MD, CEO of Quest Clinical Research and Chief Science Officer of CytoDyn, along with a representative of Amarex Clinical Research, the company’s CRO (contract research organization), will provide a comprehensive business and clinical trials update. The Wall Street Reporter’s event is scheduled for Tuesday, June 2, 2020 at 12:30 pm EDT / 9:30 am PDT. The presentation will be approximately 15-20 minutes, followed by a Q&A session of approximately 30-40 minutes. Then event can be accessed at: https://www.wallstreetreporter.com/next-superstock-online-investor-confe.... Interested participants are encouraged to login early prior to the start of the event, as the online event has a capacity of 3,000 participants. Please note that there will be no telephone access; this is a webcast-only event. The livestream presentation will be archived for 30 days. For anyone unable to attend live, a video will be posted on CytoDyn’s website approximately 24 hours after the presentation. The conference sponsor provides corporate visibility services to CytoDyn for a fee. CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S., and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

Eli Lilly Begins World's First Study of a Potential COVID-19 Antibody Treatment in Humans; First Patients Have Been Dosed in a Phase 1 Study of LY-CoV555, the Lead Antibody from Lilly's Collaboration with AbCellera

On June 1, 2020, Eli Lilly and Company (NYSE: LLY), announced that patients have been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19. This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera (https://www.abcellera.com/) to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2, the virus that causes COVID-19. The first patients in the study were dosed at major medical centers in the U.S., including the New York University (NYU) Grossman School of Medicine and Cedars-Sinai in Los Angeles. "We are committed to working with our industry partners to generate scientific evidence to meet the urgent need for treatments that reduce the severity of COVID-19 disease," said Mark J. Mulligan, MD, Director of the Division of Infectious Diseases and Immunology and Director of the Vaccine Center at NYU Langone Health. "Antibody treatments like the one being studied here hold promise to be effective medical countermeasures against this deadly infection," said Dr. Mulligan, also the Thomas S. Murphy, Sr. Professor in the Department of Medicine at NYU Langone. "We are grateful to collaborate with colleagues at AbCellera, NIAID, and the many academic institutions who have helped us reach this milestone in humanity's fight against COVID-19 — a disease first characterized only six months ago.

CytoDyn Files Request with FDA for Priority Review of BLA for First Approval of Leronlimab As Part of a Combination Therapy for HIV; If Granted, the FDA Is Expected to Take Action on the Company’s BLA Within Six Months

On June 1, 2020, CytoDyn, Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that it has filed with the U.S. Food and Drug Administration (FDA) a request seeking Priority Review designation for the company’s Biologics License Application (BLA) for leronlimab as part of a combination therapy for HIV indication. Under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times: Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). FDA informs the applicant of a Priority Review designation within 60 days. A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Significant improvement may be demonstrated by the following examples: evidence of increased effectiveness in treatment, prevention, or diagnosis of condition; elimination or substantial reduction of a treatment-limiting drug reaction; documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or evidence of safety and effectiveness in a new subpopulation.

SARS-CoV-2 Can Gain Cell Entry Via Host Proteases TMPRSS2 or Furin; While TMPRSS Is Present Chiefly in the Lungs, Furin Has a Much Wider Tissue Distribution and May Thus Be Responsible for COVID-19’s Broader Than Usual Pathogenicity; Dual Inhibitor Sought

How might the novel coronavirus SARS-CoV-2 be prevented from entering a host cell in an effort to thwart infection? A team of biomedical scientists has made a discovery that points to a solution. The scientists, led by Maurizio Pellecchia, PhD, Professor of Biomedical Sciences in the School of Medicine at the University of California, Riverside (UC-Riversidie), in an article published online on May 22, 2020 in Molecules report that two proteases (enzymes that break down proteins) located on the surface of host cells and responsible for processing viral entry could be inhibited. Such protease inhibition would prevent SARS-CoV-2, the coronavirus responsible for COVID-19, from invading the host cell. The research is featured as the cover story of the May 2020 issue of the journal (Volume 25, Issue 10). The open-access article is titled “Potential Therapeutic Targeting of Coronavirus Spike Glycoprotein Priming.” The outer surface of coronaviruses contains a critical protein called spike glycoprotein, or S-glycoprotein. Responsible for giving the coronavirus its typical crown shape, the S-glycoprotein is essential for the entry of viral particles into host cells. Host cell proteases, however, must first process or cut this viral surface protein to allow the virus to enter the cells. Dr. Pellecchia's lab and others have recognized that in addition to a previously identified protease called TMPRSS2 (transmembrane serine protease 2), the new SARS-CoV-2 coronavirus can also be processed by an additional human protease, called furin (image), for viral entry. "The use of the host protease furin for processing is a common mechanism of cell entry by both viral fusion proteins and certain bacterial toxins," said Dr. Pellecchia, who led the research team. "SARS-CoV-2 uses this mechanism also.

May 31st

Study Shows Ketamine Combats Depression by Targeting Serotonin 1B Receptors, Increasing Their Number, and Increasing Dopamine Levels

The anaesthetic drug ketamine has been shown, in low doses, to have a rapid effect on difficult-to-treat depression. Researchers at the Karolinska Institutet in Sweden now report that they have identified a key target for the drug: specific serotonin receptors in the brain. Their findings, which were published online on June 1, 2020 in Translational Psychiatry, give hope of new, effective antidepressants. The open-access article is titled “A Randomized Placebo-Controlled PET Study of Ketamine´s Effect on Serotonin1b Receptor Binding in Patients with SSRI-Resistant Depression.” Depression is the most common psychiatric diagnosis in Sweden, affecting one in ten men and one in five women at some point during their lives. Between 15 and 30 per cent of patients are not helped by the first two attempts at therapy, in which case the depression is designated difficult to treat. Studies have shown that low doses of the anaesthetic drug ketamine are rapid-acting on certain sufferers, but exactly how it works is unknown. A nasal spray containing ketamine has recently been approved in the USA and EU for patients with treatment-resistant depression. Researchers at the Karolinska Institutet have now imaged the brains of study participants using a PET (positron emission tomography) camera in connection with ketamine treatment.

New Understanding of mRNA/microRNA Interactions May Enable New Approaches to Treating Cancer

Research from Sweden’s Karolinska Institutet, published on March 27, 2020 in Nature, shows that an RNA molecule involved in preventing tumor formation can change its structure and thereby control protein production in the cell. The article is titled “Base-Pair Conformational Switch Modulates miR-34a Targeting of Sirt1 mRNA.” The finding may have important clinical implications as it [suggests the possibility of new strategies to treat different types of cancer. Short RNA molecules in our cells, called microRNAs, are important regulators of messenger RNAs (mRNAs) – the molecules that code for the building blocks of our body, the proteins. The exact mechanism of this regulation remains elusive, but it is known that microRNAs can silence mRNA molecules and thereby prevent protein production. Therefore, they have the potential to be used as tools or targets for drugs. “It’s important to increase our understanding of how microRNA regulates protein production because this process is disturbed in many different types of diseases, including cancer,” says Katja Petzold, PhD, Associate Professor in the Department of Medical Biochemistry and Biophysics at Karolinska Institutet, who led the study. “We show for the first time that a microRNA-mRNA complex has a structure that changes and that this movement has an effect on the biological outcome, i.e., the amount of protein produced in the cell.” The researchers studied a microRNA known as miR-34a, which plays an important role in cancer by indirectly regulating the activity of the p53 protein, known as the “guardian of the genome” for its ability to prevent cancer formation. Changes in the function of p53 are very common in human cancers. miR-34a downregulates the mRNA that codes for Sirt1, a protein that deactivates p53.

Modified Adenoviruses Better Able to Target and Kill Cancer Cells Due to Addition of AU-Rich Elements That Hasten mRNA Breakdown in Normal Cells, But Which Result in Stabilized mRNA in Cancer Cells, Thus Enhancing Cancer Cell-Specific Killing by the Virus

Hokkaido University scientists have made an adenovirus (graphic image of an adenovirus) that specifically replicates inside and kills cancer cells by employing special RNA-stabilizing elements. The details of the research were published online on May 11, 2020 in the journal Cancers. The open-access article is titled “Conditionally Replicative Adenovirus Controlled by the Stabilization System of AU-Rich Elements Containing mRNA.” Much research in recent years has investigated genetically modifying adenoviruses to kill cancers, with some of these modified viruses currently being tested in clinical trials. When injected, these adenoviruses replicate inside cancer cells and kill them. Scientists are trying to design more efficient viruses, which are better able to target cancer cells, while leaving normal cells alone. Hokkaido University molecular oncologist Fumihiro Higashino, PhD, led a team of scientists to make two new adenoviruses that specifically target cancer cells. To do this, they used ‘adenylate-uridylate-rich elements’ (AREs or AU-rich elements), which are signals in RNA molecules known to enhance the rapid decay of messenger RNAs (mRNAs) in human cells. “AREs make sure that mRNAs don’t continue to code for proteins unnecessarily in cells,” explains Dr. Higashino. “Genes required for cell growth and proliferation tend to have AREs.” Under certain stress conditions, however, ARE-containing mRNAs can become temporarily stabilized allowing the maintenance of some necessary cell processes. ARE-mRNAs are also stabilized in cancer cells, supporting their continuous proliferation. Dr. Higashino and his team inserted AREs from two human genes into an adenovirus replicating gene, making the new adenoviruses: AdARET and AdAREF.

SARS-CoV-2 May Ultimately Be a Blood Vessel Disease, Which Might Explain Everything

In April 2020, blood clots (https://coronavirus.medium.com/doctors-want-to-know-could-blood-thinners...) emerged as one of the many mysterious symptoms attributed to COVID-19, a disease that had initially been thought to largely affect the lungs in the form of pneumonia. Quickly after this, came reports of young people dying due to coronavirus-related strokes. Next it was COVID toes — painful red or purple digits. What do all of these symptoms have in common? An impairment in blood circulation. Add in the fact that 40% of deaths (https://www.ahajournals.org/doi/pdf/10.1161/CIRCRESAHA.120.317055) from COVID-19 are related to cardiovascular complications, and the disease starts to look like a vascular infection instead of a purely respiratory one. Months into the pandemic, there is now a growing body of evidence to support the theory that the novel coronavirus can infect blood vessels, which could explain, not only the high prevalence of blood clots, strokes, and heart attacks, but also provide an answer for the diverse set of head-to-toe symptoms that have emerged. “All these COVID-associated complications were a mystery.

FDA Publishes Comprehensive Review of What’s Known to Date on SARS-CoV-2; Outlines Roadmap for Effective Treatment of COVID-19; Proposes Range of Existing Drugs That Might Be Repurposed to Treat the Disease

Due to the devastating worldwide impact of COVID-19, the illness caused by the SARS-CoV-2 virus, there have been unprecedented efforts by clinicians and researchers from around the world to quickly develop safe and effective treatments and vaccines. Given that COVID-19 is a complex new disease with no existing vaccine or specific treatment, much effort is being made to investigate the repurposing of approved and available drugs, as well as those under development. In an article published online on May 29, 2020 in Frontiers in Immunology (https://www.frontiersin.org/articles/10.3389/fimmu.2020.01131/full) , a team of researchers from the U.S. Food and Drug Administration (FDA) review all of the COVID-19 clinical and research findings to date. They provide a breakdown of key immunological factors underlying the clinical stages of COVID-19 illness that could potentially be targeted by existing therapeutic drugs. The open-access review is titled “Lessons Learned to Date on COVID-19 Hyperinflammatory Syndrome: Considerations for Interventions to Mitigate SARS-CoV-2 Viral Infection and Detrimental Hyperinflammation.” Montserrat Puig (photo) (https://www.fda.gov/science-research/fda-science-jobs-and-scientific-pro...), PhD, of the FDA, senior author of the review, stated that "there are multiple factors involved in determining if the patient's immune response will be insufficient or successful in combating the infection. Our review is an overview of these factors and how they can be considered to define the context in which medications currently used for other diseases, or development of novel agents, can be utilized to prevent, ameliorate, or cure COVID-19." We know that during the early stage of COVID-19 people can show no symptoms or mild symptoms, and, for many, the disease resolves.

May 30th

First Evidence Inherited Genetics Can Drive Cancer's Spread; In Melanoma Model, Rockefeller Scientists Show That APOE4 Variant Is Most Protective Against Metastasis by Enhancing Anti-Tumor Immune Response

Sometimes cancer stays put, but often it metastasizes, spreading to new locations in the body. It has long been suspected that genetic mutations arising inside tumor cells drive this potentially devastating turn of events. Now, researchers at The Rockefeller University have shown for the first time that our own pre-existing genetics may promote metastasis. A new study, published online on May 25, 2020 in Nature Medicine, suggests that differences in a single gene (APOE), carried within someone's genome from birth, can alter progression of melanoma, a type of skin cancer. The researchers suspect these inherited variations may have the same effect on other types of cancer as well. Their article is titled “Common Germline Variants of the Human APOE Gene Modulate Melanoma Progression and Survival.” "Patients often ask 'Why am I so unlucky? Why did my cancer spread?' As doctors, we never had an answer," says lead investigator Sohail Tavazoie, MD, PhD, Leon Hess Professor and Senior Attending Physician at The Rockefeller University. "This research provides an explanation." The discovery may transform how scientists think about cancer metastasis, and lead to a better understanding of patients' risks in order to inform treatment decisions,” Dr. Tavazoie says. Metastasis occurs when cancer cells escape the original tissue to establish new tumors elsewhere in the body, a phenomenon that leads to the majority of cancer deaths. Scientists have suspected that cancer cells, which initially emerge due to mutations inside normal cells, gain their travelling ability following further mutations. But after decades of searching, they have yet to find such a genetic change that could be proven to encourage metastasis. Previous research (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753115/) in Dr.