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 clinical trial agreement with Jeffrey Jacobson, M.D., professor and chief of the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine, to conduct additional Phase II studies with PRO 140, an experimental humanized monoclonal antibody (mAb) targeting the CCR5 receptor for the treatment of HIV infection.
This agreement establishes a formal collaboration between Drexel University College of Medicine and CytoDyn to allow Drexel to proceed with two NIH-funded Phase IIB clinical trials totaling approximately 10 million dollars awarded to Dr. Jacobson for the study of PRO 140. The first study, entitled “Long-Acting HIV Therapy for Injection Drug Users (“NIDA Study”), is a placebo-controlled trial that will explore the combined effect of PRO 140 and the current highly active anti-retroviral therapies (HAART) on circulating virus levels in HIV-infected subjects. The second placebo-controlled study, entitled “Long-Acting, Self-Administered HIV Therapy with the CCR5 Antibody PRO 140 (“NIAID Study”), will measure the effect of different doses and dosing schedules of PRO 140 alone on circulating virus levels in drug-naïve HIV-infected subjects. This second study will also measure the effect of PRO 140 treatment on the levels of CD17 cells, a subset of CD4 cells that are thought to control inflammation.
Under the terms of this Agreement CytoDyn will provide a total of approximately 5000 doses of PRO 140 to Drexel University College of Medicine. CytoDyn will also provide FDA regulatory support for the clinical trials, which will be conducted under its current investigational new drug (IND) application for PRO 140. In return, CytoDyn will have the right to use the data from these studies to maintain its investigational new drug (IND) application for PRO 140 to support future clinical trial applications to the FDA.
“We are very happy to work with Dr. Jacobson as our lead clinical investigator. Dr. Jacobson has deep experience from previous studies with PRO 140. Our affiliation with him and with Drexel University College of Medicine and the strong support from the National Institutes of Health for this clinical research will allow the PRO140 program to move ahead with the hope of providing new therapeutic alternatives for HIV-positive individuals,” said Dr. Nader Pourhassan, CytoDyn’s interim President and CEO.
“I am pleased that we will be able to move forward with further studies of this unique, promising drug,” commented Dr. Jacobson.
Dr. Richard Trauger, CytoDyn’s Chief Scientific Officer, commented, “These two NIH-funded and FDA sanctioned Phase IIB placebo-controlled clinical studies are designed to determine the optimum therapeutic regimen for future PRO 140 clinical trials and to explore the ability of PRO 140 to protect a critical type of immune cell whose loss is thought to contribute to chronic inflammation in HIV infected individuals. We believe that these results will provide important clinical information needed to improve our understanding of the role of the CCR5 molecule in viral cellular entry and will move the PRO 140 clinical program forward.”
CytoDyn is a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses and other antibody applications. Its proprietary drug candidate Cytolin(R) is a monoclonal antibody that binds to CD11a, a cellular antigen that is a component of the cellular adhesion molecule LFA-1. With the addition of Pro 140, CytoDyn intends to explore the clinical development of cell-specific monoclonal antibodies as viral entry inhibitors to determine if they can perturb the natural course of HIV infection in persons infected with the Human Immunodeficiency Virus ('HIV"). In addition, CytoDyn is exploring the possible application of its existing proprietary monoclonal antibody for the treatment of Feline Immunodeficiency Virus ("FIV"), a retroviral infection in cats. CytoDyn recently filed for a provisional patent for the use of these antibodies as well as selected small molecule antagonists and agonists for the treatment of FIV, and filed an application for registration of the trademark CytoFeline, intended for use in conjunction with veterinary preparations for the treatment of FIV. For more information about Pro 140, Cytolin(R), CytoFeline(TM) and the company please go to www.cytodyn.com.
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.