VANCOUVER, Washington, April 09, 2020 (GLOBE NEWSW
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Posted On: 04/09/2020 6:00:46 AM
VANCOUVER, Washington, April 09, 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 a patient with severe COVID-19 under the care of a leading medical center in Southern California exhibited clinical improvement after treatment with the Company’s investigational new drug, leronlimab. The patient was intubated and in critical condition in the ICU, and had received an IL-6 blocking agent four days earlier without apparent benefit. Concomitantly, the patient also received either an antiretroviral agent or placebo as part of an unrelated clinical trial. With no clinical improvement observed over the ensuing four days, the patient then received leronlimab under an emergency IND granted by the U.S. Food and Drug Administration (FDA). Within twenty-four hours of receiving an injection of leronlimab, the patient showed significant clinical improvement and was removed from external ventilation three days later. This outcome is consistent with that observed in severely ill COVID-19 patients treated with leronlimab at a leading medical center in New York City.
Additionally, two patients at the same Southern California medical center with moderate COVID-19, were treated with leronlimab under an EIND and subsequently revealed clinical improvement. These patients were removed from external oxygen support one day following leronlimab treatment, and subsequently discharged from the hospital. Based on these results, an additional four patients with moderate COVID-19 have been administered leronlimab and results are pending.
The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway. The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.
CytoDyn has initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and is enrolling in a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We continue to be extremely encouraged by patient responses to treatment with leronlimab and are making every effort to distribute our drug as widely and as rapidly as possible for these critically ill and mild-to-moderate patients. It is very gratifying to receive heartfelt expressions of appreciation from patients.”
, a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a patient with severe COVID-19 under the care of a leading medical center in Southern California exhibited clinical improvement after treatment with the Company’s investigational new drug, leronlimab. The patient was intubated and in critical condition in the ICU, and had received an IL-6 blocking agent four days earlier without apparent benefit. Concomitantly, the patient also received either an antiretroviral agent or placebo as part of an unrelated clinical trial. With no clinical improvement observed over the ensuing four days, the patient then received leronlimab under an emergency IND granted by the U.S. Food and Drug Administration (FDA). Within twenty-four hours of receiving an injection of leronlimab, the patient showed significant clinical improvement and was removed from external ventilation three days later. This outcome is consistent with that observed in severely ill COVID-19 patients treated with leronlimab at a leading medical center in New York City. Additionally, two patients at the same Southern California medical center with moderate COVID-19, were treated with leronlimab under an EIND and subsequently revealed clinical improvement. These patients were removed from external oxygen support one day following leronlimab treatment, and subsequently discharged from the hospital. Based on these results, an additional four patients with moderate COVID-19 have been administered leronlimab and results are pending.
The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway. The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.
CytoDyn has initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and is enrolling in a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We continue to be extremely encouraged by patient responses to treatment with leronlimab and are making every effort to distribute our drug as widely and as rapidly as possible for these critically ill and mild-to-moderate patients. It is very gratifying to receive heartfelt expressions of appreciation from patients.”
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