CytoDyn submits manufacturing section of interim order application for leronlimab as coronavirus treatment to Health Canada

CytoDyn Inc (OTCQB:CYDY) said that it has submitted the crucial manufacturing section (CMC) of the application, for an interim order to Health Canada for its flagship drug leronlimab to be considered as a medical treatment for coronavirus (COVID-19), under a rolling review.  Vancouver, Washington-based CytoDyn is developing leronlimab (PRO 140) for multiple indications. The company explained that the crucial part of the application documents the company’s “manufacturing practices are in full compliance with GMP requirements.” The company said it anticipates the remaining sections will be submitted in the “very near future.” In a statement, CytoDyn CEO Nader Pourhassan said: “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.” READ: CytoDyn says its coronavirus long-haulers trial now fully enrolled faster than expected “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 US, 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.” Pourhassan noted that the company is quickly advancing leronlimab along “multiple regulatory paths,” including securing “additional manufacturing from Samsung BioLogics in 2021 and 2022.” Meanwhile, CytoDyn revealed that the former president of the Philippines, Joseph Estrada, was administered leronlimab under compassionate special permit (CSP), among other medications, as a treatment for COVID-19. “Estrada remains hospitalized and news reports indicate he may be transferred from the ICU to a regular hospital room soon,” said the company. CytoDyn continues to ship vials of leronlimab to the Philippines, while its distribution partner, Chiral Pharma Corporation, works closely with the Philippine FDA to consider expanding the CSP, added the company. Pourhassan said: “We have been working with Chiral Pharma for several months to provide COVID-19 patients in the Philippines access to leronlimab under CSP. CytoDyn is grateful for the opportunity to help the former President and his family and we wish him a full and speedy recovery.” “While we pursue emergency use authorizations in many countries and initiate final trials for the severe and critical COVID-19 patient populations to strengthen these applications, our teams remain hopeful their dedication and efforts will help COVID-19 patients around the world.” CytoDyn’s leronlimab works by mitigating what is known as the cytokine storm, a hyperactive immune response that can cause inflammation, fatigue and in severe cases, organ failure in COVID-19 patients. Aside from COVID-19, the US Food & Drug Administration (FDA) has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. “We also are happy to report our BLA resubmission for HIV is on track and we are encouraged with the advancements in our expanding cancer program,” said Pourhassan. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive