VANCOUVER, Washington, July 26, 2016, CYDY, (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces the enrollment of the first patient under a recently modified protocol in the Company’s Phase 3 combination study with PRO 14O (humanized monoclonal antibody to CCR5). The modified protocol has been cleared by the U.S. Food and Drug Administration (FDA) and features a 50% reduction in enrollment to 150 subjects and relaxed enrollment criteria allowing HIV-infected subjects to enter the study before confirmation of the R5 strain. PRO 140 has proven effective in managing the viral load of people infected with the R5 strain of HIV, which accounts for approximately 67% of infected Americans and up to 85% of those newly diagnosed.
This first enrolled patient under the recently modified trial protocol is in addition to patient enrollment under the previous protocol, in which the first patient to have successfully completed the trial was transitioned to a compassionate use protocol, at the request of the treating physician, so as to continue on PRO 140 therapy with a suppressed viral load.
The multicenter, randomized Phase 3 combination study is evaluating the efficacy and safety of PRO 140 combined with standard of care antiretroviral therapy (ART) in treatment-experienced HIV-infected patients who are failing their ART therapy. The study is divided into two parts, with part one as a double-blind treatment period in which study subjects are randomized and treated with either PRO 140 or placebo weekly subcutaneous injections in combination with their failing ART regimen for up to one week. During this week, each subject is evaluated for HIV-1 genotypic drug resistance and a new optimized ART regimen is developed. In the second part of the study, subjects continue treatment with either PRO 140 or placebo in combination with the optimized background therapy (OBT) for up to an additional three weeks, when the HIV-1 co-receptor tropism assay results (i.e., determination of R5 strain) are available. At this time, subjects will move to a 24-week, open-label period. Only subjects with R5 virus will be treated with PRO 140 and OBT, whereas subjects with X4 or dual/mixed-tropic virus will receive OBT alone during the 24-week open-label treatment period.
“We expect to enroll subjects at a much faster pace under this newly modified protocol, which allows for those with HIV viral load over 400 cp/mL to be treated with PRO 140 and OBT without waiting for their tropism test results,” said Nader Pourhassan, Ph.D., CytoDyn President and CEO. “The prior protocol required that study subjects continue on failed ART while waiting for validation of the R5 strain, which could take several weeks and was a deterrent to enrollment. We have shown that PRO 140 is safe for HIV-infected patients with dual mix or X4 exclusive strains of HIV in our completed Phase 2b monotherapy clinical trial.”
“We are excited to quickly enroll our first subject following FDA-clearance of the modified protocol and we anticipate being able to announce topline findings on the primary endpoint in 2017,” Dr. Pourhassan added.
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 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 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.
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 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 seven 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 indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit www.cytodyn.com.
This press release includes forward-looking statements and forward-looking information within the meaning of United States securities laws, including statements regarding CytoDyn’s combination therapy trial and other current and proposed trials and studies and their results 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, 2016 and other reports filed with the U.S. Securities and Exchange Commission.