Health Canada Clears CytoDyn to File its BLA for Leronlimab as One Injection per Week for Combination HIV Therapy
VANCOUVER, Washington, Nov. 16, 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 Health Canada has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as
a combination therapy for multi-drug resistance HIV patients in Canada.
Health Canada’s clearance for the BLA filing includes a treatment regimen of one injection per week of 350 mg of the Company’s product leronlimab, as contrasted to the dosage used in the Phase 3 clinical trial conducted in the U.S. for this indication of two consecutive injections of 175 mg per week. Health Canada, a department of the Government of Canada, is responsible for Canada’s federal health policy and oversees the Public Health Agency of Canada. Health Canada’s team conducted a two-hour meeting with CytoDyn's team and were also updated on the progress of the Company’s COVID-19 trials and BLA application for the U.K. CytoDyn’s presentation team to Health Canada included Drs. Thomas Boyd, Nitya Ray and Kush Dhody for pre-clinical, manufacturing and clinical sections, respectively, of the application.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased with Health Canada’s decision to clear our BLA for filing and our team is motivated to submit this filing in the very near future. Health Canada’s decision continues to validate the opportunity for leronlimab as a treatment for HIV patients around the world. Our lengthy meeting included an update on the progress of our COVID-19 trials and plans to simultaneously file our BLA for leronlimab as a combination therapy for HIV with the MHRA in the U.K. and Health Canada.”
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. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Company’s website under the “Clinical Trial Enrollment” section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again after enrollment reaches 293 patients.
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