VANCOUVER, Washington, May 13, 2022 (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, today announced the addition of Dr. Paul Edison, Dr. Kabir Mody, and Dr. Otto Yang to the Company’s Scientific Board of Advisors. In addition, Dr. Jay Lalezari has agreed to serve as an outside Scientific Advisor to the Company.
Dr. Paul Edison is a Senior Clinical Lecturer in Neuroscience in the Department of Brain Sciences at Imperial College London and an honorary Professor at Cardiff University. He is also the Editor-in-Chief of the journal Brain Connectivity. After his clinical training (MD), Dr. Edison received his MPhil and Ph.D. from Imperial College London, and then completed his higher training in London Deanery and obtained his CCT from the Postgraduate Medical Education and Training Board. He then became a Fellow of the Royal College of Physicians, Ireland, and Fellow of the Royal College of Physicians, UK. He has published in such highly regarded journals as Brain, Annals of Neurology, and Neurology, and has received grants from the Medical Research Council, NIHR/HEFCE, Alzheimer’s Society, Alzheimer’s Research UK, Alzheimer’s Drug Discovery Foundation US, and other funders. He collaborates closely with Novo Nordisk, GE Healthcare, Novartis, Piramal Life Sciences, and Astra Zeneca. He has also received several best paper awards internationally and published in leading scientific journals. His work now focuses on neuroinflammation and the interplay between inflammation and immunity in neurodegenerative and neuroinflammatory disease, and relating these with genetic information. He is also evaluating the methods of modulating inflammation and amyloid in Alzheimer’s disease, and the influence of cardiometabolic factors on the development of neurodegenerative diseases by means of clinical and pre-clinical studies.
Dr. Kabir Mody is the Medical Director at IMV, Inc. and a board-certified medical oncologist. He brings a wealth of experience and knowledge in oncology and immuno-oncology accumulated while working at Mayo Clinic as an academic oncologist focused on GI oncology, particularly cancers of the liver and the pancreas. Dr. Mody received his MD from St. George’s University School of Medicine, and completed his residency at St. Luke’s-Roosevelt Hospital in New York City, and a fellowship at Dartmouth Hitchcock Medical Center in New Hampshire. He has co-authored numerous papers and book chapters, including many on the biology and novel treatment strategies of liver and pancreas malignancies, and has been actively involved in leading both clinical and lab-based research on cancers of the liver and pancreas.
Dr. Otto Yang is a Professor of Medicine, Infectious Diseases, Microbiology, Immunology & Molecular Genetics at UCLA and has a background in clinical infectious diseases. His laboratory specializes in T cell immunology in HIV infection, relevant to developing immune therapies and vaccines for HIV and potentially other diseases, including cancer and other viral infections. He received his MD degree from Brown University, with subsequent residency training at NYU-Bellevue Hospital and subspecialty/postdoctoral training at Harvard-Massachusetts General Hospital. He then pursued a fellowship at Massachusetts General Hospital, where he developed a research program studying the role of CD8+ T lymphocytes (CTL, which are killer T cells that can destroy cells infected with viruses or which are malignant) in HIV-1 pathogenesis. A more recent research interest has been the role of CTL in the development of rejection in organ transplant patients. Dr. Yang has begun working with the new composite tissue transplantation program at UCLA, which will perform hand and face transplants, studying the role of this arm of immunity in causing tissue rejection. Dr. Yang is a frequent lecturer, has received numerous research grants and funding for his work and published over 180 peer-reviewed articles, and holds numerous patents in HIV and Immunology.
Dr. Jacob (Jay) Lalezari has agreed to serve as an outside Scientific Advisor to CytoDyn without compensation. Dr. Lalezari has been the CEO and Medical Director of Quest Clinical Research since 1997. He received his MD degree from the University of Pennsylvania and his MA from the University of Virginia. He also received a BA from the University of Rochester. He received his board certification from the American Board of Internal Medicine. He briefly served as interim Chief Medical Officer of CytoDyn during 2020, as well as Chief Medical Officer of Virion Therapeutics. Dr. Lalezari has served as Principal Investigator for Phase I, II, and III clinical studies of new therapies for such viral diseases as HIV/AIDS, CMV, HPV, HSV, Hepatitis B and C, Influenza, RSV, and COVID-19, including clinical trials conducted by the Company. He has published extensively and is a well-regarded international speaker and patient advocate.
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 is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the regulatory determinations of leronlimab’s safety and effectiveness to treat the diseases and conditions for which we are studying the product by the U.S. Food and Drug Administration (FDA) and various drug regulatory agencies in other countries; (ii) the Company’s ability to raise additional capital to fund its operations; (iii) the Company’s ability to meet its debt obligations; (iv) the Company’s ability to recruit a permanent CEO and retain other key employees; (v) the Company’s ability to enter into partnership or licensing arrangements with third-parties; (vi) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion; (vii) the timely and sufficient development, through internal resources or third-party consultants, of analyses of the data generated from the Company’s clinical trials required by the FDA or other regulatory agencies in connection with applications for approval of the Company’s drug product; (viii) the Company’s ability to achieve approval of a marketable product; (ix) the design, implementation and conduct of the Company’s clinical trials; (x) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results; (xi) the market for, and marketability of, any product that is approved; (xii) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products; (xiii) regulatory initiatives, compliance with governmental regulations and the regulatory approval process; (xiv) legal proceedings, investigations or inquiries affecting the Company or its products; (xv) general economic and business conditions; (xvi) changes in foreign, political, and social conditions; (xvii) stockholder actions or proposals with regard to the Company, its management, or its board of directors; and (xviii) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, as well as risk factors and cautionary statements included in subsequent Form 10-Qs and Form 8-Ks, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
Cristina De Leon