CytoDyn Reports Primary Endpoint Achieved in PRO 140 Pivotal Combination Therapy Trial in HIV Infection
Results demonstrate statistically significant reduction in HIV-1 RNA viral load with PRO 140 versus placebo
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February 20, 2018
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.
VANCOUVER, Washington, Feb. 20, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY) reports the successful achievement of the primary endpoint in its CD02 Phase 2b/3 pivotal clinical trial with PRO 140 in combination with existing antiretroviral therapy (ART) in patients failing their current HIV therapy. The trial data show a statistically significant reduction in HIV-1 RNA viral load of greater than 0.5log with PRO 140 versus placebo. CytoDyn is developing PRO 140, a humanized CCR5 monoclonal antibody, to combat human immunodeficiency virus (HIV) infection and certain immunologic disorders.
"These data clearly demonstrate the anti-HIV-1 activity of PRO 140 in antiretroviral treatment-experienced individuals who were documented to have ongoing virus replication in the face of therapy with currently approved drugs," said Scott M. Hammer, MD, Harold C. Neu Professor and Chief of the Division of Infectious Diseases, Columbia University Medical Center/New York-Presbyterian Hospital. "Antiviral drug resistance is an ongoing threat to HIV infected persons. Despite the dramatic progress in treatment success over the course of the epidemic, we cannot be complacent. Agents with different mechanisms of action, modes of delivery, and frequencies of administration are needed to provide patients with the options necessary to achieve and sustain virologic suppression. PRO 140 is a clear example of the advances in HIV therapeutics that can result from the dedication of developers, patients and providers to this principle."
"The standard approach to ART therapy has been to administer combinations of oral medications that must be taken daily," said Robert T. Schooley, MD, Professor of Medicine, Department of Infectious Diseases and Global Public Health, University of California, San Diego. "Recently, there has been increasing interest in the development of drugs that do not require daily administration. I believe that PRO 140 is a step in that direction. These PRO 140 trial findings support the potential of managing HIV by blocking its entry into T cells through a novel humanized monoclonal antibody administered in weekly subcutaneous injections. PRO 140 could provide an important new therapeutic option in suppressing a patient's viral load as well as deterring the spread of this disease."
Trial Design and Efficacy Endpoint Results
This multicenter clinical trial enrolled 52 patients with CCR5-tropic HIV-1 and documented genotypic or phenotypic resistance to ART drugs within three drug classes or within two or more drug classes with limited treatment options. Enrolled patients all had plasma HIV-1 RNA ≥400 copies/mL and documented detectable viral load within three months prior to the screening visit.
In the one-week, randomized, double-blind, placebo-controlled portion of the trial, all trial patients received their existing ART therapy, with one-half of the enrolled patients administered a 350mg subcutaneous injection of PRO 140 and the other half receiving a subcutaneous injection of placebo. The trial's primary endpoint was the proportion of participants with greater than 0.5log reduction in HIV-1 RNA viral load from baseline at the end of the one-week treatment period. At one week, patients in the PRO 140 arm showed a statistically significant reduction in HIV-1 RNA viral load of greater than 0.5log from baseline versus patients in the placebo arm, (p<0.01). Following this one-week period, all patients continue in the trial for an additional 24 weeks with PRO 140 weekly subcutaneous injections and optimized ART.
"The high virologic response rate seen following a single PRO 140 injection in this study is exciting given the status of these treatment-experienced patients who were failing their antiretroviral therapies," said Paul J. Maddon, MD, Ph.D., Senior Science Advisor to CytoDyn, an inventor of PRO 140 and retired founder, Chairman, CEO and CSO of Progenics Pharmaceuticals, Inc. "These data suggest that PRO 140 could provide a vital treatment option for patients and physicians and a potent evolution in HIV therapy."
"It is truly exciting that PRO 140 surpassed the one-week viral load reduction endpoint in what is certainly our most significant clinical trial result to date for this therapeutic candidate," said Nader Pourhassan, Ph.D., CytoDyn's President and Chief Executive Officer. "Given these positive results in the combination treatment setting with PRO 140 in HIV, we look forward to completing enrollment in our ongoing monotherapy trial in HIV infection."
The target for PRO 140, CCR5, is the trafficking receptor on immune cells that is responsible for directing them to the sites where they produce inflammatory reactions. CytoDyn is currently evaluating PRO 140 in transplantation, autoimmune, inflammatory and cancer indications where CCR5 has been implicated to play a critical role. The Company's first human evaluation of PRO 140 in this area is an ongoing Phase 2 trial in graft-versus-host disease (GvHD) for leukemia and lymphoma patients requiring a bone marrow stem cell transplant. To date, PRO 140 has been generally well tolerated with no drug-related major adverse events or treatment discontinuation reported.
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is 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 by the FDA. The FDA also granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD). The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with 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 humans and is currently in Phase 3 development. 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, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.
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