VANCOUVER, Wash. — CytoDyn Inc. (OTCQB: CYDY), 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.
About CytoDyn’s Partnership with Albert Einstein College of Medicine and Montefiore Medical Center
In December 2023, the Company entered a partnership with Albert Einstein College of Medicine and Montefiore Medical Center, located in New York. The Company will be providing leronlimab to support a pre-clinical trial evaluating the efficacy of leronlimab independently and in combination with temozolomide in treating glioblastoma multiforme, also known as grade IV astrocytoma (GBM) in infected humanized mice. The study will involve three groups of humanized mice: one control group, one group that will receive only leronlimab, and another group that will receive a combination of leronlimab and temozolomide. The primary objective of this study is to evaluate the effect of leronlimab on the primary tumor growth and occurrence of metastases on CCR5+ and CCR5- cells in humanized mice. Upon completion of the study, the academic institutions will provide the Company with a research report outlining the study results, and they will have the right to publish and present the study results. GBM is the most common type of primary malignant brain tumor and is aggressive and fast-growing. This study is expected to take place in the 2024 calendar year.
Contact
Investor Relations
CytoDyn Inc.
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