Chiral Pharma Corp. to Assist Philippine Physicians Apply for Compassionate Special Permit (CSP) to Access CytoDyn’s Leronlimab for COVID-19 Patients, as Philippines FDA Reviews Each Application for Approval to Sell Leronlimab for CSP Use
CytoDyn will dedicate at least 200,000 vials (100,000 doses) of leronlimab from its inventory to Chiral Pharma Corp. for potential sales in the Philippines
VANCOUVER, Washington, Jan. 29, 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 the potential for multiple therapeutic indications, announced today it is working with Chiral Pharma Corp. in the Philippines to register Vyrologix under a licensed physician’s request for Compassionate Special Permit (CSP) to treat COVID-19 patients with leronlimab for a fee. Last night, the CytoDyn team presented the results from various studies (primarily from U.S. eIND patients) of leronlimab as a potential therapeutic for COVID-19 patients to several Philippine regulators, hospital executives and physicians. Drs. Seethamraju and Agresti discussed their patient experiences with leronlimab for critical COVID-19 patients under eIND. References were also made to several published papers by Drs. Otto Yang and Nicholas Agresti, among others, for the treatment of COVID-19 patients with leronlimab.
CytoDyn appointed Chiral Pharma, a subsidiary of New Marketlink Pharmaceutical Corporation (NMPC), to register Vyrologix for potential approval from the Food and Drug Administration in the Philippines to treat COVID-19 patients.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased to initiate sales of Vyrologix (leronlimab) in the Philippines as soon as we have CSP approved for patients. Under the CSP program, we will also generate significant data from Philippine patients with COVID-19. We continue to look forward to unblinding the data from our Phase 2b/3 clinical trial very soon and remain optimistic given the results from many eIND patients in the U.S.A., who were in a similar clinical condition as the patients in our CD12 trial.”
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in early February 2021.