GeoVax Labs, Inc. Strategy Supported by Encouraging Results of European Therapeutic HIV/AIDS Vaccine Trial
Success In Viral Load Reduction & Control of Virus, By Vaccine Recipient's Immune System Who Have Been Weaned from ART Therapy;
Encouraging News for HIV/AIDS Vaccine Community
ATLANTA, Nov. 29, 2010 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), announced it was pleased to learn of the partial success observed in the recently completed Phase 2b trial of a therapeutic HIV/AIDS vaccine produced by Bionor Immuno AS of Oslo, Norway. Bionor reported success in reducing viral load (reduction in HIV virus in the blood stream) in individuals who were vaccinated then weaned from anti-retroviral therapy (ART). HIV replication was reduced as the result of the vaccine recipient's immune system.
Robert McNally, Ph.D., Chief Executive Officer and President stated, "In the war against HIV/AIDS, vaccines have two unmet objectives. First of all, the fight continues to design vaccines which will prevent an individual from being infected by HIV and, for those individuals already infected with HIV, the development of a therapeutic vaccine to supplement the existing anti-retroviral drug regimens. Earlier this year Argos Therapeutics presented data from their Phase 2 clinical trial designed to test a vaccine based on an individualized medicine approach. They observed a greater than 20-fold reduction of HIV replication in approximately 65% of individuals responding to the vaccine. The Bionor vaccine reduced HIV replication by approximately 5-fold in the population of treated individuals. This announcement gives encouragement to all participants in the HIV/AIDS vaccine effort. Ultimately, success for a therapeutic vaccine will be achieved."
The Bionor product, designated Vacc-4x, consists of four synthetic peptides derived from a major HIV structural protein. The vaccine is injected in combination with a human cytokine (Granulocyte-macrophage colony stimulating factor-GM-CSF) which serves as an adjuvant to augment immune responses. The vaccine is thought to function by stimulating the expansion of both CD4+ (helper) and CD8+ (killer) T cells. GeoVax HIV/AIDS vaccine products are likewise designed to induce T cell based immune responses, but unlike the Bionor product, our vaccines also induce antibody responses to reduce the rate of virus spread in treated individuals.
"Within the two main areas of focus for HIV/AIDS vaccines – preventative and therapeutic – GeoVax continues to make progress," stated Dr. McNally. "Our preventative vaccine candidate is being tested in a Phase 2a trial sponsored by the Division of AIDS (National Institutes of Health) and conducted by the HIV Vaccine Trials Network (HVTN). Assessment of the therapeutic potential of GeoVax's vaccine is being tested in an ongoing Phase 1 trial which will include ART interruption; a design feature similar to both the Argos and Bionor trials. Active recruitment among recently infected HIV individuals is underway for our Phase 1 therapeutic trial."
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV (Human Immunodeficiency Virus – that leads to AIDS). Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing 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. All preventative Phase 1 human clinical trials conducted to date were designed to test combinations and dose levels of our DNA and MVA vectored vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (CD4+ helper and CD8+ cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported the initiation of the first Phase 2 testing. GeoVax's Phase 2 human trial began in January 2009 and will ultimately involve 300 participants at sites in the United States and South America. Recently GeoVax began enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.
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.
At The Investor Relations Group:
Janet Vasquez / Robin O'Malley
SOURCE GeoVax Labs, Inc.
Posted: November 2010