ATLANTA, GA--(Marketwire - December 18, 2012) - GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, is pleased to announce full enrollment in a 48 patient Phase 1 trial testing the safety and immunogenicity of its 2nd generation adjuvanted DNA/MVA vaccine for the prevention of HIV infection. The adjuvant, granulocyte-macrophage colony-stimulating factor (GM-CSF), enhances the vaccine response by recruiting and stimulating white blood cells that initiate immune responses at the site of vaccination. The Phase 1 trial (designated HVTN 094) consists of priming with a recombinant DNA vaccine followed by boosting with a recombinant modified vaccinia Ankara (MVA) vaccine, and is being conducted by the NIH-sponsored HIV Vaccine Trials Network (HVTN).
The GeoVax use of the GM-CSF adjuvant is unique in that instead of co-inoculating with the GM-CSF protein, the GM-CSF adjuvant is encoded in the same DNA that expresses HIV non-infectious virus-like-particles. This ensures that GM-CSF is immediately present at every site where vaccine responses are being initiated and allows very low levels of GM-CSF to have a profound effect on the vaccine responses. In non-human primate studies, the co-expression of GM-CSF in simian prototypes of GeoVax's HIV vaccine achieved a 90% per exposure rate of protection against twelve serial rectal challenges with the heterologous SIVE660 virus, which translated to 70% of vaccinated animals being protected against all twelve challenges. Based on these outstanding results, the 2nd generation adjuvanted form of the GeoVax vaccine is being advanced in human trials.
"We are extremely pleased with the speed with which the HVTN clinical research sites enrolled HVTN 094 and with the impressive safety results," said Harriet Robinson, Ph.D., Chief Scientific Officer of GeoVax. "There is no reason to anticipate that GM-CSF might prove unsafe, because it has approved uses in humans and our co-expression of GM-CSF with our vaccine results in very low levels of GM-CSF enhancing protective responses in the non-human primate model."
Robert T. McNally, Ph.D., GeoVax's President & CEO, commented, "Now that the enrollment stage of the Phase 1 trial is finished, we look forward to completion of the trial in mid-2013. With the Phase 2a trial of our first generation HIV vaccine successfully completed, we will be working with the HVTN and NIH to plan the next steps of our vaccine development."
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing of these vaccines under GMP/GLP conditions (FDA guidelines), conducting clinical trials for vaccine safety and effectiveness, and obtaining regulatory approvals to move the product forward. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from a Phase 1 study supported a Phase 2a trial that was completed in the 3rd quarter of 2012.
GeoVax's 2nd generation preventive vaccine is currently in phase 1 testing and may progress to multi-stage phase 2 efficacy testing, given safety and immunogenicity are as expected. Overall, the GeoVax vaccine, in various doses and combinations, has been tested in close to 500 humans. GeoVax is also enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.
HIV infection, which can lead to AIDS, is a pandemic that can affect anyone, regardless of race, gender, age, or sexual orientation. 33 million people are currently infected globally; it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, more than a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with HIV. Globally, HIV is the top killer among women of reproductive age. HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B and C. GeoVax vaccines are currently designed to function against clade B. For more information, please visit www.geovax.com.
About the HVTN
The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of preventive HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.