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Posted On: 06/01/2021 9:17:53 AM
Post# of 148921
CytoDyn Receives First Purchase Order from Chiral Pharma Corporation for Use of Leronlimab Under CSP for COVID-19 Patients in the Philippines
Chiral is simultaneously working on application for Emergency Use Authorization
VANCOUVER, Washington, June 01, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company developing Vyrologix™ (leronlimab-Pro 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today that Chiral Pharma Corporation in the Philippines placed its first purchase order for leronlimab under a Compassionate Special Permit (“CSP”) to treat critically ill COVID-19 patients in the Philippines. The Company expects to recognize revenues related to this purchase order upon fulfillment of the purchase order and the terms of the agreement.
Chris Recknor, M.D., Chief Operating Officer and Head of Clinical Development of CytoDyn, said, "Current Philippine CSP data is significant for 21% mortality rate which is below that observed in CD12. One of the patient successes was recently reported last week on One News Philippines TV station. This patient had severe COVID-19 with deteriorating lung function despite treatment with antivirals and steroids. Testing was significant for high inflammation in the blood with Ferritin 17x elevated. Oxygen saturation on maximum oxygen flow was only 82% (normal >95%). Twenty hours after receiving 700 mg of leronlimab subcutaneously at the patient's home, the patient's heart rate decreased from 120s to low 90s. Shortly thereafter the patient regained appetite, improved lung function, and had reduced inflammation with Ferritin down to 4x elevated. At week two, the patient successfully went off oxygen shortly after second dose also given at home. At week three, the patient continued to improve in stamina and returned to routine physical activities. Inflammation markers were still elevated with Ferritin still two times elevated, so a third dose was given. At week four, the patient is currently back to normal life activities."
Dr. Recknor further stated, “Although the CSP data is not randomized double-blinded control, the numerous case reports from the Philippine CSP are consistent with CD12 prespecified major endpoint metrics showing Vyrologix when combined with standard of care is better than standard of care alone (e.g. antivirals/dexamethasone) and may improve clinical outcome status four times better than standard of care at day 14 (p< 0.021) and reduce hospital stay by as much as 6 days (p<0.005) with a higher likelihood of returning to activities of daily living without limitations vs. placebo control in critical COVID patients."
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “After we provided leronlimab, free of charge, for the first 100 patients in the Philippines for critically ill COVID-19 patients, we are now on a clear path to achieving revenue with our first purchase order today under CSP from Chiral Pharma. We are so proud to be able to provide leronlimab in the capital region where the use of intensive care unit (ICU) capacity is above 70% for COVID-19 patients with hospital beds in great shortage. We are equally excited about our EUA package (CMC, non-clinical and clinical sections) being prepared for submission to the Philippine FDA.“
Chiral is simultaneously working on application for Emergency Use Authorization
VANCOUVER, Washington, June 01, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company developing Vyrologix™ (leronlimab-Pro 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today that Chiral Pharma Corporation in the Philippines placed its first purchase order for leronlimab under a Compassionate Special Permit (“CSP”) to treat critically ill COVID-19 patients in the Philippines. The Company expects to recognize revenues related to this purchase order upon fulfillment of the purchase order and the terms of the agreement. Chris Recknor, M.D., Chief Operating Officer and Head of Clinical Development of CytoDyn, said, "Current Philippine CSP data is significant for 21% mortality rate which is below that observed in CD12. One of the patient successes was recently reported last week on One News Philippines TV station. This patient had severe COVID-19 with deteriorating lung function despite treatment with antivirals and steroids. Testing was significant for high inflammation in the blood with Ferritin 17x elevated. Oxygen saturation on maximum oxygen flow was only 82% (normal >95%). Twenty hours after receiving 700 mg of leronlimab subcutaneously at the patient's home, the patient's heart rate decreased from 120s to low 90s. Shortly thereafter the patient regained appetite, improved lung function, and had reduced inflammation with Ferritin down to 4x elevated. At week two, the patient successfully went off oxygen shortly after second dose also given at home. At week three, the patient continued to improve in stamina and returned to routine physical activities. Inflammation markers were still elevated with Ferritin still two times elevated, so a third dose was given. At week four, the patient is currently back to normal life activities."
Dr. Recknor further stated, “Although the CSP data is not randomized double-blinded control, the numerous case reports from the Philippine CSP are consistent with CD12 prespecified major endpoint metrics showing Vyrologix when combined with standard of care is better than standard of care alone (e.g. antivirals/dexamethasone) and may improve clinical outcome status four times better than standard of care at day 14 (p< 0.021) and reduce hospital stay by as much as 6 days (p<0.005) with a higher likelihood of returning to activities of daily living without limitations vs. placebo control in critical COVID patients."
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “After we provided leronlimab, free of charge, for the first 100 patients in the Philippines for critically ill COVID-19 patients, we are now on a clear path to achieving revenue with our first purchase order today under CSP from Chiral Pharma. We are so proud to be able to provide leronlimab in the capital region where the use of intensive care unit (ICU) capacity is above 70% for COVID-19 patients with hospital beds in great shortage. We are equally excited about our EUA package (CMC, non-clinical and clinical sections) being prepared for submission to the Philippine FDA.“
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My comments are just my opinions and should NOT be taken as investment advice.
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