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From: m4e (Rep: 139)Date: 11/13/2019 09:04
Forum: Pinks and BB - Msg #138174 - List GOVX msgs Thread #674107590 (Rec: 0)
Clinical Trial Expected to Commence in Early 2020

ATLANTA, GA, Nov. 13, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- GeoVax Labs, Inc. (OTCQB: GOVX) announced today its participation in a collaborative effort led by researchers at the University of California, San Francisco (UCSF), to develop a combinational therapy aimed at inducing remission in HIV-positive individuals (a “functional cure”). The studies will be conducted with funding from amfAR, The Foundation for AIDS Research.

The proposed clinical trial will enroll 20 HIV-infected adults who are on stable and effective antiretroviral therapy (ART). The therapeutic regimen to be tested involves a combination of vaccinations (DNA priming and MVA boosting), administration of broadly neutralizing antibodies (bNAbs) and a Toll-like receptor 9 (TLR9) agonist. GeoVax will provide its novel boost component (MVA62B) for use in the studies. MVA62B is the boosting component for GeoVax’s preventive HIV vaccine (GOVX-B11) which has successfully completed a Phase 2a clinical trial and is awaiting funding in support of a Phase 2b pivotal trial.

The planned trial, the most comprehensive test to date for the ability of synergistic approaches to control HIV infection, is led by Dr. Steven Deeks of UCSF, a world leader in therapeutic approaches to HIV infections. The primary objectives of the trial will be to assess the safety and tolerability of the combinational therapy and to determine the viral load “set-point” during a treatment interruption. Secondary objectives will be to assess immune responses and changes in viral reservoir status. Patient enrollment for the clinical trial is expected to commence in early 2020.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “In a previous therapeutic Phase 1 clinical trial conducted by GeoVax, we demonstrated that our vaccine can potently stimulate production of both CD8+ and CD4+ T cells in HIV-positive individuals – the intended use of the MVA62B vaccine in the proposed UCSF therapeutic study. Our vaccine also has a well-documented safety profile in >500 humans. We are hopeful that the combination of technologies in these studies will yield a promising regimen to purge the latent HIV reservoirs and achieve a much-needed functional cure for HIV.”

“It is exciting to see this trial becoming a reality,” said Harriet Robinson, PhD, CSO Emeritus of GeoVax. “Dr. Deeks and UCSF have cohorts of infected individuals which are uniquely suited to this trial. The protocols, regulatory submissions and obtaining the products for this multi-product approach to HIV control have been in process for well over 2 years. We will learn an enormous amount from the outcome, and truly hope we will achieve improved drug-free control of viremia and reductions in viral reservoirs.”

David Dodd, GeoVax’s President and CEO, stated, “Finding a cure for HIV/AIDS remains an elusive but critical goal, and GeoVax is pleased to be a contributor to this important effort. While current antiretroviral therapy is effective at suppressing the viral load of HIV-infected individuals and preventing progression to AIDS, the long-term use of ART can lead to loss of drug effectiveness and can come with severe side effects. Additionally, the financial burden of drug and other medical costs to both the individual and to society at large is staggering, with average lifetime medical costs of treating an HIV-positive individual in the U.S. estimated to exceed $350,000.”
***caution with this's headed for another reverse split-m4e

Dumb luck streak going on twenty years. Follow at your own risk  ;O)

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