CytoDyn Announces Collaboration with Dr. Bruce Torbett, The Scripps Research Institute, to study PRO 140 in a Pre-exposure Prophylaxis (PrEP) Model of HIV Infection

PORTLAND, Ore.--(BUSINESS WIRE)--CytoDyn Inc. (“CytoDyn”) (OTC QB: CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that it has entered into a research collaboration with Dr. Bruce Torbett of The Scripps Research Institute to study CytoDyn's experimental humanized anti-CCR5 antibody PRO 140 in a pre-exposure prophylaxis (PrEP) model of HIV infection.

“It is well established that CCR5 is an essential co-receptor required for HIV infection”

The purpose of this study is to assess the potential for the use of PRO 140 to prevent HIV infection. “Published clinical data has demonstrated that PRO 140 has anti-viral activity. We believe that it is an important next step for the company to investigate the possibility that PRO 140 might have a role in HIV prevention,” commented Dr. Nader Pourhassan, CytoDyn’s President and CEO.

“It is well established that CCR5 is an essential co-receptor required for HIV infection,” said Dr. Richard Trauger, CytoDyn’s Chief Scientific Officer. “Previously published results from clinical trial subjects have shown that a single administration of PRO 140 can coat CCR5 positive cells for up to 45 days, potentially rendering them resistant to HIV infection. The duration of this effect may allow for an infrequent dosing regimen suitable for the use of PRO 140 in a preventive setting. We are excited to initiate this collaboration with Dr. Torbett to determine, in an animal model of HIV infection, whether administration of PRO 140 can prevent or significantly diminish a primary HIV infection.”

The Company

CytoDyn is a biotechnology company focused on developing subcutaneously delivered humanized cell-specific monoclonal antibodies (mAbs) as entry inhibitors for the treatment and prevention of HIV and FIV. We currently have two mAbs under development for HIV infection. PRO 140, recently acquired from Progenics Pharmaceuticals, is a Late Stage II humanized mAb with demonstrated antiviral activity in man. PRO 140 blocks the Human Immunodeficiency Virus (HIV) co-receptor CCR5 without affecting the normal function of the molecule. Results from Phase I and Phase IIa human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV. The second humanized mAb under development is Cytolin, which targets LFA-1, a membrane associated molecule reported to be important for entry and fusion of HIV to target cells and for cell-to-cell transmission. CytoDyn is also exploring the possibility that its anti-LFA-1 strategy to control HIV infection may be effective to treat feline immunodeficiency virus (FIV) a retroviral infection in cats, as well. To test this hypothesis, CytoDyn is developing CytoFeline, a monoclonal antibody that blocks feline LFA-1. For more information please go to www.cytodyn.com.

Forward-Looking Statements

This press release includes forward-looking statements and forward-looking information within the meaning of United States securities laws. These statements and information represent CytoDyn’s intentions, plans, expectations and beliefs, and are subject to risks, uncertainties and other factors, of which many are beyond CytoDyn’s control. These factors could cause actual results to differ materially from such forward-looking statements or information. The words “believe,” “estimate,” “expect,” “intend,” “attempt,” “anticipate,” “foresee,” “plan,” and similar expressions and variations thereof, identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made. CytoDyn disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or forward-looking information.

While it is impossible to identify or predict all such matters, these differences may result from, among other things, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and product candidates, including the risks that clinical trials will not commence or proceed as planned; products appearing promising in early trials will not demonstrate efficacy or safety in larger-scale trials; future clinical trial data on our products and product candidates will be unfavorable; our products will not receive marketing approval from regulators or, if approved, fail to gain sufficient market acceptance to justify development and commercialization costs; competing products currently on the market or in development may reduce the commercial potential of our products; CytoDyn, our collaborators or others may identify side effects after the product is on the market; or efficacy or safety concerns regarding marketed products, whether or not scientifically justified, may lead to product recalls, withdrawals of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling of the product, the need for additional marketing applications, or other adverse events.

We are also subject to additional risks and uncertainties, including risks associated with the actions of our corporate, academic and other collaborators and government regulatory agencies; risks from market forces and trends; potential product liability; intellectual property, litigation, environmental and other risks; and risks that current and pending patent protection for our products may be invalid, unenforceable or challenged, or fail to provide adequate market exclusivity. There are also substantial risks arising out of our need to raise additional capital to develop our products and satisfy our financial obligations; the highly regulated nature of our business, including government cost-containment initiatives and restrictions on third-party payments for our products; the highly competitive nature of our industry; and other factors set forth in our Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission.