VANCOUVER, Wash., Jan. 28, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that 11 patients have achieved full virologic suppression in the Phase 2b extension study evaluating long-term suppression of HIV replication by PRO 140 monotherapy. These patients self-administered PRO 140 weekly for 14 to 17 months. Using a very sensitive, single-copy HIV-1 RNA assay, seven of 10 patients had less than one viral copy per milliliter in their blood in the most recent month of treatment. The median of the lowest HIV RNA levels detected in these 10 patients was 0.4 viral copies per milliliter of blood.
CytoDyn’s PRO 140 Phase 2b study was completed in January 2015. Following the initial 13-week treatment period, patients with viral load suppression were trained to self-administer PRO 140 and offered continuation of monotherapy in an ongoing extension study with biweekly monitoring up to 60 weeks and monthly monitoring beyond 60 weeks. Patients enrolled in this study are infected with strains of HIV that utilize exclusively the CCR5 co-receptor. The PRO 140 monoclonal antibody targets CCR5 with high affinity and blocks HIV infection. These patients substituted their daily Anti-Retroviral Therapy (ART) regimen with weekly subcutaneous injections of PRO 140 monotherapy throughout the trial and extension study. PRO 140 was well tolerated with no drug-related major adverse events or treatment discontinuation reported.
Denis R. Burger, Ph.D., CytoDyn’s Chief Science Officer, commented, “For more than one year, PRO 140 provided maximal virologic suppression, was well tolerated, and enabled the avoidance of potential toxicity of ART, while preserving drug options. These results support further development of PRO 140 as a simple, long-acting, single-agent maintenance therapy in selected patients.”
Dr. Nader Pourhassan, President and CEO, commented: “We believe this data clearly supports our planned label expansion study with PRO 140 as a monotherapy for HIV patients. Success with PRO 140 monotherapy in the label expansion Phase 3 study means that, if approved, PRO 140 could change the HIV-treatment paradigm and provide a potential solution to what has been a nagging problem in the HIV patient population, which is compliance with taking multiple pills daily for life. PRO 140’s easy, subcutaneous delivery is the first such alternative to existing ART therapy and the toxicity issue associated with such treatments. We are very pleased with our results thus far and future possibilities for certain patients infected with HIV.”
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 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.
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.
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 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, 2015 and other reports filed with the U.S. Securities and Exchange Commission.
Media: Nader Pourhassan, Ph.D. Office: 360-980-8524 E-mail: firstname.lastname@example.org