CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma

VANCOUVER, Washington, Feb. 01, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has submitted its revised HIV clinical trial protocol to the FDA. The Company believes this submission will lead to the removal of the clinical hold currently in effect.

CytoDyn’s CEO, Dr. Jacob Lalezari stated, “Our HIV protocol has been revised and resubmitted following FDA input, and will study leronlimab in HIV patients who have increased inflammation and immune activation, which causes heart attacks, strokes, and other vascular events. We believe this protocol will help clarify the mechanisms by which leronlimab can be used as an immune modulator in HIV and a variety of other therapeutic areas.”

In addition, the Company announced that its research partnership with Albert Einstein College of Medicine and Montefiore Medical Center is moving forward with a pre-clinical trial designed to study leronlimab in glioblastoma, a common and often untreatable form of primary brain cancer. Initial preparations have commenced for a trial to take place in 2024, one of potentially several pre-clinical trials to be conducted with Montefiore Medical Center.

As to the partnership with Montefiore Medical Center, Dr. Lalezari stated, “I am excited to start this pre-clinical trial with Albert Einstein College of Medicine and Montefiore Medical Center in New York. Glioblastoma is a common and often untreatable form of primary brain cancer. CytoDyn is fortunate to be able to evaluate the potential effects of leronlimab in a pre-clinical model of this all too often deadly cancer.”

About CytoDyn

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.