FDA Clears CytoDyn for Relaxed Entry Criteria for Its Ongoing Phase 3 Trial in HIV-Infected Patients

VANCOUVER, Wash., Dec. 21, 2015 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that the FDA has allowed a significant change to the entry criteria for patients in the Company’s ongoing PRO 140 Phase 3 trial. This change allows the Company to enroll patients with resistance to a single antiretroviral drug, significantly expanding the number of patients available for the study.

The Company’s Phase 3 trial is designed to evaluate PRO 140 in combination with current antiretroviral therapy (ART) in 300 individuals. Patients enrolled in this study are infected with strains of HIV-1 that exclusively use the CCR5 co-receptor for entry into T-cells. PRO 140 is a monoclonal antibody that targets the CCR5 molecule on the surface of T-cells preventing viral entry and infection.

The 25-week study is divided into two parts, a one week efficacy phase and a 24 week safety and durability phase. Initially, subjects on a failing ART regimen (HIV replication due to resistance to one or more antiviral drugs) are randomized to PRO 140 or placebo for a comparison in reduction in viral load after one week. In the second phase, the two patient populations are combined and all patients receive PRO 140 added to a new background of ART that is optimized by resistance testing. In this part, safety, durability of initial response, and emergence of drug resistance are to be measured over 24 weeks.

The Phase 3 trial was initiated in October and was to include enrollment of patients with resistance to antiretroviral drugs within two or more drug classes. The relaxed entry criteria now includes patients with resistance to antiretroviral drugs within one or more drug classes. These individuals must demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy and have limited treatment options.

Dr. Nader Pourhassan, President and CEO, commented: “We are pleased that the FDA has granted CytoDyn relaxed entry criteria for subjects in our ongoing Phase 3 trial to include patients with a single drug resistance. This is expected to significantly accelerate enrollment in the trial and allow us to test PRO 140 in a broader patient population with limited treatment options. We believe that this change will also significantly expand the potential market for PRO 140, if the trial is successful.”

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 Human Immunodeficiency Virus (HIV) infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has finished Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3. 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 six 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 weeks 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. For more information on the Company, please visit www.cytodyn.com.

About PRO 140

PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140 is a fully 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 towards CCR5 but does have antagonist activity to CCL5 which is a central mediator in inflammatory diseases. PRO 140 has been the subject of seven 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 candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.

Forward-Looking Statements

This press release includes forward-looking statements and forward-looking information within the meaning of United States securities laws, including statements regarding the Company’s Phase 3 study, including its enrollment and completion. These statements and information represent CytoDyn’s intentions, plans, expectations, and beliefs and are subject to risks, uncertainties and other factors, many 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 CytoDyn’s 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 CytoDyn’s products and product candidates will be unfavorable; funding for additional clinical trials may not be available; CytoDyn’s products may not receive marketing approval from regulators or, if approved, may 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 CytoDyn’s products; CytoDyn, its 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.

CytoDyn is also subject to additional risks and uncertainties, including risks associated with the actions of its 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 its products may be invalid, unenforceable, or challenged or fail to provide adequate market exclusivity. There are also substantial risks arising out of CytoDyn’s need to raise additional capital to develop its products and satisfy its financial obligations; the highly regulated nature of its business, including government cost-containment initiatives and restrictions on third-party payments for its products; the highly competitive nature of its industry; and other factors set forth in CytoDyn’s Annual Report on Form 10-K for the fiscal year ended May 31, 2015 and other reports filed with the U.S. Securities and Exchange Commission.

CONTACT: Media: Dr. Nader Pourhassan Office: 360-980-8524 E-mail: npourhassan@cytodyn.com

Source:CytoDyn Inc.