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Archive - Jul 4, 2020

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Protective Antibodies Identified for Rare, Polio-Like Disease in Children

Researchers at Vanderbilt University Medical Center, Purdue University and the University of Wisconsin-Madison have isolated human monoclonal antibodies that potentially can prevent a rare, but devastating, polio-like illness in children linked to a respiratory viral infection. The results have been published as the cover story of the July 3, 2020 issue of Science Immunology, and the article is titled “Human Antibodies Neutralize Enterovirus D68 and Protect Against Infection and Paralytic Disease.” The illness, called acute flaccid myelitis (AFM), causes sudden weakness in the arms and legs following a fever or respiratory illness. More than 600 cases have been identified since the U.S. Centers for Disease Control and Prevention (CDC) began tracking the disease in 2014. There is no specific treatment for AFM, which tends to strike in the late summer or early fall, and which has been associated with some deaths. However, the disease has recently been linked to a group of respiratory viruses called enterovirus D68 (EV-D68). Researchers at the Vanderbilt Vaccine Center isolated antibody-producing blood cells from the blood of children who had previously been infected by EV-D68. By fusing the blood cells to fast-growing myeloma cells, the researchers were able to generate a panel of monoclonal antibodies that potently neutralized the virus in laboratory studies. Colleagues at Purdue determined the structure of the antibodies, which shed light on how they specifically recognize and bind to EV-D68. One of the antibodies protected mice from respiratory and neurologic disease when given either before or after infection by the enterovirus.

CytoDyn Announces Execution of Exclusive Agreement with American Regent for Distribution and Supply of Leronlimab for Treatment of COVID-19 in United States, Pending Trial Results & FDA Approval

On July 3, 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 signed an exclusive Distribution and Supply Agreement with American Regent, Inc. (“American Regent”) (https://www.americanregent.com/) for the distribution of leronlimab for the treatment of COVID-19 in the United States. Under the terms of the agreement, CytoDyn will supply leronlimab for the treatment of COVID-19 for distribution by American Regent and receive quarterly payments based on a profit-sharing arrangement. “Having this distribution agreement in place ahead of the readout from CytoDyn’s COVID-19 clinical trials further emphasizes CytoDyn’s commitment to making leronlimab immediately available to patients based on the successful completion of its ongoing clinical trials,” said Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn. “We are particularly happy to be partnering with a company with the proven expertise, unparalleled commercial reach, and stellar reputation of American Regent.” “American Regent is looking forward to partnering with CytoDyn to provide COVID-19 patients rapid and efficient access to a potentially life-saving drug,” said Mr. Harsher Singh, American Regent’s Vice President and Chief Commercial Officer. CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients, which is a randomized, placebo-controlled trial with 2:1 ratio (active drug to placebo ratio). CytoDyn has also completed its enrollment of a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S.

CytoDyn CEO on DrBeen Webcast July 4, 2020 (9 pm EDT) (YouTube & FB) to Discuss with Mobeen Syed, MD, the Many Potential Opportunities for Anti-CCR5 Monoclonal Antibody Leronlimab, Including Treatment of COVID-19, HIV, & Triple-Negative Breast Cancer

CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, has announced that Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn will be interviewed on the DrBeen webcast hosted by Mobeen Syed, MD, on Saturday, July 4, 2020 at 9:00 pm EDT (6 pm PDT, 7 pm MDT, and 8 pm CDT). The interview will be available simultaneously on two channels:

YouTube - DrBeen Medical Lectures
Link: https://www.youtube.com/c/USMLEOnline

Facebook: DrBeen Medical
Link: https://m.facebook.com/drbeenmedical

CYTODYN & CORONAVIRUS DISEASE 2019(COVID-19): CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in CytoDyn’s Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country. SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.