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     583  0 Kommentare U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

    A leading academic medical center has administered the test medication, leronlimab, in two of their sickest COVID-19 patients. Neither patient has had any serious adverse reactions to leronlimab since it was administered. We are hopeful leronlimab will provide help to severely ill COVID-19 patients.

    VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that two coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA). Leronlimab is intended to serve as a therapy for patients who experience respiratory illness as a result of contracting the Coronavirus Disease 2019 (COVID-19). The treatment of these patients was not under the Company’s proposed randomized controlled Phase 2 clinical trial protocol recently submitted to the FDA.

    Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn, added, “Leronlimab binds to the CCR5 receptor inhibiting the migration of macrophages and the release on inflammatory cytokines including TNF and IL-6. This release of cytokines is what is commonly referred to as the 'cytokine storm' and is believed to cause profound damage in the lungs in some patients. In addition, leronlimab can block Regulatory T cells (Tregs), which can inhibit the innate immune response against pathogens, into areas of inflammation. These combined mechanisms of action may reduce the morbidity and mortality in moderate to severe cases of COVID-19, preventing the acute respiratory distress syndrome associated with this highly destructive and potentially fatal disease.”

    Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, “We are very pleased that we have a potential treatment option for patients affected by COVID-19 infection. To be very clear, leronlimab does not kill the novel coronavirus. It acts as a CCR5 antagonist by blocking pro-inflammatory cytokines, which prevents cytokine storm and thus could be useful in treatment of COVID-19. Leronlimab is administered as a once-a-week injection. It has a strong safety profile demonstrated in nine clinical trials with over 800 people and is available for urgent treatment. If results are promising, we have leronlimab available for immediate use and the ability to scale production. We are open and willing to work with government agencies and pharmaceutical partnerships to assist in serving those in dire need of a treatment option for this devastating disease. We appreciate the FDA’s prompt response and are working in full support of the treating medical team.”

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    U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab A leading academic medical center has administered the test medication, leronlimab, in two of their sickest COVID-19 patients. Neither patient has had any serious adverse reactions to leronlimab since it was administered. We are hopeful leronlimab …