CytoDyn and FDA Will Meet to Potentially Finaliz

CytoDyn and FDA Will Meet to Potentially Finalize Protocol for Pivotal Monotherapy Trial for Leronlimab

https://www.cytodyn.com/media/press-releases/...e-protocol

CYTODYN IS ALSO COORDINATING WITH AN INTERNATIONAL PUBLIC HEALTH AGENCY TO FULLY FUND AN HIV PREVENTION STUDY WITH LERONLIMAB

VANCOUVER, Washington, June 07, 2019 (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, announces that the U.S. Food and Drug Administration (“FDA”) has requested an in-person meeting to discuss and potentially finalize the Company’s recently submitted protocol for a pivotal monotherapy trial with leronlimab. The Company will announce further details when available.

Management is also developing a clinical trial collaboration agreement to initiate a HIV prevention study to be conducted by and fully funded by a public health agency in Southeast Asia. CytoDyn’s President and CEO, Nader Pourhassan, Ph.D., stated: “We believe there are over 130,000 individuals using a currently approved drug for the prevention of HIV. The side effects and long-term morbidities are well known, which include, among others, kidney and liver complications, bone density issues, headaches, abdominal pain and weight loss. Based upon leronlimab’s mechanism of action, our collaborating partners are very excited to initiate a prevention study, and we share their enthusiasm about the possibilities.”

“The potential role of the CCR5 co-receptor in the prevention of and cure for HIV has been very well documented and has been the subject of major media attention,” added Dr. Pourhassan. “There is only one self-injectable humanized monoclonal antibody, leronlimab, which is near approval that targets CCR5. Leronlimab is one dose-a-week, sub-cutaneous injection that has all the characteristics of potentially becoming a major therapeutic contributor to the field of HIV and perhaps in cancer and auto-immune diseases. The support of our shareholders has enabled our Company to advance leronlimab towards an anticipated FDA approval, in addition to exploring many opportunities in various cancer indications, any of which could offer significant benefits and rewards for patients throughout the world and for all of our stakeholders.”