CytoDyn Submits First and Most Crucial Section (CMC) of Interim Order Application to Health Canada for COVID-19 Under Rolling Review
Clinical trial in U.S. for critically ill COVID-19 patients expected to initiate soon
CytoDyn in discussions with Brazil to initiate two COVID-19 trials, one for severe and one for critically ill patients
VANCOUVER, Washington, April 19, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today it has submitted the manufacturing section (CMC) of the application for an Interim Order to Health Canada under a rolling review. This crucial part of the application documents the Company’s manufacturing (CMC) practices are in full compliance with GMP requirements. The Company anticipates the remaining sections will be submitted in the very near future.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “Our entire regulatory team has been working non-stop to complete the submission of the manufacturing section of the Interim Order to Health Canada for leronlimab to be considered as a therapeutic for COVID-19. Our clinical team is working on initiating three trials in parallel. In Brazil, two clinical trial protocols for COVID-19 will be submitted to ANVISA, the Brazilian regulatory authority. In the U.S., we will soon finalize a COVID-19 trial protocol to potentially include a dosage regimen utilizing IV (intravenous) as the first dose and three subcutaneous doses thereafter. We are moving quickly to advance leronlimab along multiple regulatory paths, including securing additional manufacturing from Samsung BioLogics in 2021 and 2022.”
About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (nonalcoholic steatohepatitis). Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).