GeoVax Presents HIV Vaccine Clinical Trial Data
Results of HIV Immunotherapy Vaccine Trial Presented at HIVR4P Conference
ATLANTA, GA, October 29, 2014 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines using its novel DNA/MVA platform technology, today announced that its Chief Scientific Officer, Harriet L. Robinson, Ph.D., gave an oral presentation entitled Elicitation of Immune Responses by a DNA/MVA Vaccine in ART Treated Patients in a Treatment Interruption Trial. Dr. Robinson delivered the presentation at the HIV Research for Prevention 2014: AIDS Vaccine, Microbicide and ARV-based Prevention Science (HIVR4P) conference in Cape Town, South Africa.
Dr. Robinson’s presentation focused on GeoVax’s Phase 1 trial (GV-TH-01) investigating the therapeutic potential of its DNA/MVA vaccine regimen (GOVX-B11) in HIV-infected patients, which was completed earlier in 2014. GOVX-B11 was tested for safety and immunogenicity in nine HIV-infected patients who were on antiretroviral drug therapy (ART). After completing the inoculation series, patients suspended ART for a 12-week period and were observed for their ability to control virus re-emergence in the absence of drugs. ART was re-instituted after 12 weeks, and trial participants were observed for an additional 6 months.
Strong safety data results were observed throughout the trial. In GeoVax’s final analysis of the study, the Company concluded that GOVX-B11 enhanced CD8+ T cell responses in essentially all participants and that most vaccine-elicited CD8+ T cells recognized re-emergent virus. CD8+ T cell responses are critical for the recognition and killing of cells harboring a reactivated infection. However, GOVX-B11 did not prevent viral re-emergence or control re-emergent virus to levels that minimize immune escape. Dr. Robinson noted during her presentation that the Company’s analysis of the data and observations from the trial suggest that the DNA/MVA vaccine might contribute to “cure” regimens in which participants remain on ART while being treated with a shock agent timed to reactivate latent virus at a peak vaccine response.
Based on data and observations from GV-TH-01, GeoVax is now planning an additional clinical trial to further develop its HIV immunotherapy program. Current antiretroviral therapies, though highly effective at suppressing HIV viral load, are unable to eliminate HIV infection entirely. A major challenge in the development of HIV therapeutics is the ability of HIV to persist in host cells in a latent proviral form, invisible to the immune system and inaccessible to antiretroviral drugs. In response to this problem, the NIH and other leaders in the HIV field have developed a new concept: the “shock and kill” strategy, in which patients remain on drugs while one drug (“shock agent”) is used to activate latent HIV and a second drug (“kill agent”) is used to recognize and eliminate cells that harbor the reactivated virus. A shock and kill therapy could potentially contribute to a cure for HIV. GeoVax is now planning a Phase 1b trial to evaluate the use of its DNA and MVA vaccines as an approach to a cure.
About GeoVax
GeoVax Labs, Inc. (OTCQB: GOVX) is a biotechnology company developing human vaccines using its novel DNA/MVA vaccine delivery platform. The Company’s lead development program is focused on vaccines to prevent, and treat, Human Immunodeficiency Virus (HIV) infections. Recently it has initiated a program to develop an Ebola virus vaccine. GeoVax’s unique, two component HIV vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV antibody and anti-HIV T cell immune responses. GeoVax’s DNA and MVA vaccines are used in a prime/boost protocol in which priming is done with the DNA and boosting with the MVA. Priming and boosting can also be done with the MVA. Both the DNA and MVA express the three major proteins of the HIV virus: Gag, Pol, and Env, and produce non-infectious virus-like particles. GeoVax’s vaccines are unique in expressing virus-like particles that display the native form of the trimeric membrane-bound HIV-1 envelope glycoprotein. Clinical trials for GeoVax’s preventive HIV vaccines have been conducted by the US National Institutes of Health-supported HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Disease (NIAID). Overall, GeoVax’s vaccines, in various doses and combinations, have been tested in close to 500 humans. GeoVax is using its MVA vaccine platform to develop a vaccine to prevent acquisition of the Ebola virus. Efforts are focused against the current epidemic version of the virus. For more information, go to www.geovax.com.
