CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients
CytoDyn expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks
VANCOUVER, Washington, Feb. 22, 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 the CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential.
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. CytoDyn completed enrollment of 394 patients in its Phase 2b/3 randomized clinical trial (CD12) for the severe-to-critically ill COVID-19 population and is in the processing of evaluating the data.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.