Cytodyn Inc (CYDY)

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CytoDyn’s Two-Year Update on Its PRO 140 Monotherapy Study in HIV Accepted at CROI 2017


VANCOUVER, Washington, Nov. 16, 2016 (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 that an abstract featuring results from its ongoing Phase 2b extension study with PRO 140 as a monotherapy for the treatment of patients with HIV has been accepted for a poster presentation, as well as a “themed discussion” at the Conference on Retroviruses and Opportunistic Infections (CROI), which is being held in Seattle from February 13 to 16, 2017.

The abstract, “PRO 140 Single-Agent Maintenance Therapy for HIV-1 Infection: A 2-Year Update," was selected for a Themed Discussion Presentation by the CROI Program Committee. This presentation will include four or five abstracts merged into a special theme-oriented, hour-long discussion featuring a brief summary of noteworthy results, conclusions and discussion points. The presentations will be followed by an interactive discussion that synthesizes the relevant information of the abstracts, covers key points of agreement and controversy and draws comparisons to related work in the scientific field.

The abstract will provide an update on 10 patients with HIV who have successfully achieved complete viral load suppression for more than two years with PRO 140 administered in weekly subcutaneous injections. Complete virologic suppression is defined as plasma HIV-1 RNA less than 40 copies/mL, which is the lower limit of detection in the commercial assay for HIV detection and is the level at which HIV transmission is reduced by more than 96%.

“The results from this ongoing extension study are highly significant as PRO 140 is being substituted for the current standard of care Highly Active Antiretroviral Therapy (HAART),” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Only about 30% of patients achieve lifelong viral load suppression on HAART, which also has notable drawbacks such as highly regimented daily dosing, toxicity and incomplete recovery of the immune system. All patients in the Phase 2b monotherapy study were evaluated for infection with strains of HIV-1 that utilize the CCR5 co-receptor as PRO 140 targets CCR5 with high affinity and potently blocks HIV-1 cell entry.

“We look forward to having results from our ongoing extension study presented to the many researchers and others involved in HIV/AIDS who will be attending CROI 2017,” added Dr. Pourhassan. “We are advancing PRO 140 through the clinical development process both as a monotherapy and in combination with HAART. We anticipate announcing our primary efficacy endpoint results from the pivotal Phase 3 combination trial as early as the first quarter of 2017.”

CROI Conference
The annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational and clinical researchers from around the world to share the latest studies, important developments and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI is a global model of collaborative science and the premier international venue for bridging basic and clinical investigation to clinical practice in the field of HIV and related viruses. Additional information about the conference is available at http://www.croiconference.org/.