CytoDyn Forms Scientific Advisory Board to Advance PRO 140 Development in Immunological Disorders

New Advisors include Leaders in Immunology, Oncology and Drug Development

VANCOUVER, Washington, March 29, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY) announces the formation of a Scientific Advisory Board to advise on the development of PRO 140 in certain immunologic disorders. PRO 140 is a humanized monoclonal antibody under development by CytoDyn that targets the CCR5 receptor, a molecule that modulates the immune cell trafficking crucial for the development of certain inflammatory conditions.

“It is a privilege to assemble this group of prominent authorities in immunology, oncology and drug development to advise on the development of PRO 140 in immunologic disorders,” said Denis R. Burger, Ph.D., Chief Science Officer of CytoDyn. “PRO 140 has potential applications in cancer progression, transplantation rejection, autoimmunity, and chronic inflammation. Based on the strength of preclinical and clinical study data combined with human safety and efficacy data from our HIV program, we believe PRO 140 warrants further development across a range of immunological indications.”

Members of CytoDyn’s Scientific Advisory Board are as follows:

  • David Hinrichs, Ph.D., is a research scientist at the Veterans Administration Medical Center in Portland, Oregon and Professor of Molecular Microbiology and Immunology at Oregon Health & Science University (OHSU). He received a B.S. in Biology from Mankato State and Ph.D. in Microbiology and Immunology from the University of Arizona.
     
  • Patrick Iversen, Ph.D., is adjunct professor at Oregon State University and scientific founder and Chief Science Officer of LS Pharma, LLC., a biopharmaceutical company focused on the discovery and development of novel RNA-based therapeutics. Dr. Iversen earned a B.S. degree from Westminster College and Ph.D. in Biochemical Pharmacology and Toxicology from the University of Utah School of Medicine.
     
  • Daniel Lindner, MD, Ph.D., is Director of Animal Tumor Core of the Taussig Cancer Institute at the Cleveland Clinic. He received a BS in biology from MIT, medical degree from Georgetown University, Ph.D. in microbiology from the Medical College of Wisconsin.
     
  • Richard Pestell, MD, Ph.D., MB.BS, FRACP, FACP, FAAAS, MBA, FRS of Medicine, is President of the Pennsylvania Cancer and Regenerative Medicine Research Center and Distinguished Professor at the Baruch S. Blumberg Institute. He received a medical degree from the University of Western Australia, Ph.D. from the University of Melbourne and conducted postdoctoral research at the Harvard School of Medicine and Massachusetts General Hospital. He received his executive MBA from New York University Stern School of Business.
     
  • David L. Porter, MD, is the Jodi Fisher Horowitz Professor of Leukemia Care Excellence and Director of Cell Therapy and Transplantation at the University of Pennsylvania. He received his medical degree from Warren Alpert Medical School of Brown University.
     
  • Jonah Sacha, Ph.D., is associate professor at OHSU and has appointments in the Vaccine & Gene Therapy Institute and Oregon National Primate Research Center. He received his Ph.D. in Medical Microbiology & Immunology from the University of Wisconsin-Madison and B.S. in Biology from the University of Missouri-Columbia. 

About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is intended to protect healthy cells from viral infection. PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T cells by masking this required co-receptor, CCR5. Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. PRO 140 has been the subject of eight clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product by the FDA. The FDA also granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD). The PRO 140 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.

About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in humans and is currently in Phase 3 development. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from eight Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.

Forward-Looking Statements 
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding our current and proposed trials and studies and their enrollment, results, costs and completion. 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. Our forward-looking statements are not guarantees of performance and actual results could differ materially from those contained in or expressed by such statements. In evaluating all such statements, we urge you to specifically consider the various risk factors identified in our Form 10-K for the fiscal year ended May 31, 2017 in the section titled “Risk Factors” in Part I, Item 1A, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.

Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii) our ability to complete our Phase 2b/3 pivotal combination therapy trial for PRO 140 (CD02) and to meet the FDA’s requirements with respect to safety and efficacy to support the filing of a Biologics License Application, (iii) our ability to meet our debt obligations, if any, (iv) our ability to identify patients to enroll in our clinical trials in a timely fashion, (v) our ability to achieve approval of a marketable product, (vi) design, implementation and conduct of clinical trials, (vii) the results of our clinical trials, including the possibility of unfavorable clinical trial results, (viii) the market for, and marketability of, any product that is approved, (ix) the existence or development of vaccines, drugs, or other treatments for infection with the Human Immunodeficiency Virus that are viewed by medical professionals or patients as superior to our products, (x) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xi) general economic and business conditions, (xii) changes in foreign, political, and social conditions, and (xiii) various other matters, many of which are beyond our control. Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by our forward-looking statements.

We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act, to the extent applicable. Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.

CONTACTS:

Investors:
LHA Investor Relations
Jody Cain
Phone: 310-691-7100
Email: jcain@lhai.com

Media:
Joan E. Kureczka
Bioscribe, Inc.
Phone: 415-821-2413
Email: Joan@bioscribe.com

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Source: CytoDyn Inc.