GeoVax Labs, Inc.'s Promising HIV/AIDS Vaccine Trial Data Presented at Retrovirus Conference
- Category: Vaccines
- Published on Friday, 08 February 2008 12:09
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Planning for Phase 2 is Underway
ATLANTA, GA, USA | February 7, 2008 | Dr. Harriet Robinson, lead scientist and co-founder of GeoVax Labs, Inc., (OTC Bulletin Board: GOVX) an Atlanta-based biotechnology company developing HIV/AIDS vaccines, co-presented successful Phase I trial results at the 15th Conference on Retroviruses and Opportunistic Infections (CROI), February 5 in Boston. Dr. Robinson, a co-founder of the GeoVax HIV-1 AIDS vaccine technology, jointly presented the findings, entitled "GeoVax Clade B DNA/MVA HIV/AIDS Vaccine is Well Tolerated and Immunogenic when Administered to Healthy Seronegative Adults," with Dr. Bernard Moss of the U.S. National Institutes of Allergy and Infectious Diseases and co-founder of the GeoVax vaccine.
In the presentation, Robinson reported that a dose escalation study showed that a 1/10th dose and an anticipated normal dose of the GeoVax vaccine both elicit anti-viral CD4 and anti-viral CD8 T cells. However, the fuller dose elicited a higher number of antibody responders.
For the normal dose, 77 percent of the participants had responding CD4 T cells; 42 percent had responding CD8 T cells, and 88 percent experienced an anti-Env antibody response. The vaccine was also found to be safe.
Based on the excellent immune response rates and the GeoVax HIV/AIDS vaccine's ability to protect non human primates against AIDS development in pre-clinical challenge models, planning of a large Phase 2 trial is underway and tentatively scheduled for a mid-2008 start.
As recently announced, due to the significant advances by GeoVax's HIV/AIDS vaccine development program, Dr. Robinson is joining the GeoVax management full time on February 15, 2008, as Vice President of Research and Development. By focusing her efforts exclusively at GeoVax, Dr. Robinson intends to speed up the vaccine development and human trial evaluation program required to meet FDA regulatory requirements and future vaccine commercialization efforts.
Dr. Robinson stated, "Our AIDS vaccine efforts are rapidly moving forward to a new and exciting level and include plans for initiating Phase 2 human trials in 2008. It's important to me to be able to work full time with the GeoVax team to learn absolutely everything we can from our phase 2 trials so that we appropriately set the stage for phase 3 efficacy trials. I believe in the GeoVax vaccine and want to carry it forward as rapidly and as effectively as possible for worldwide use for the prevention of AIDS."
The HIV Vaccine Trials Network (HVTN) in Seattle is testing GeoVax's HIV/AIDS vaccines. HVTN funded and supported by the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines. The National Institute of Allergy and Infectious Diseases of the U.S. National Institute of Health funded pre-clinical work enabling the development of the clinical evaluation of GeoVax's DNA and MVA vaccines.
The NIH recently provided additional support to GeoVax's vaccine development program in the form of a $15 million IPCAVD grant awarded in October 2007.
GeoVax Labs, Inc.
GeoVax Labs, Inc. (http://www.geovax.com) is a biotechnology company established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's vaccine technology is covered by 20 issued or filed patent applications. GeoVax HIV/AIDS vaccines are designed to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1. GeoVax HIV/AIDS vaccines may be effective as therapeutics (treatment of people infected with AIDS virus). Studies evaluating these vaccines in HIV/AIDS infected individuals are in the planning stage.
GeoVax's core HIV/AIDS vaccine technologies were developed through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and the GeoVax team.
GeoVax HIV/AIDS vaccines are moving forward in human clinical trials administered by the HIV Vaccine Trials Network (HVTN-Division of the National Institutes of Health). Two (2) human trials have been successfully completed and three (3) human trials involving over 105 individuals are currently ongoing with excellent safety and positive anti-HIV-1 immune responses in the majority of vaccine recipients. GeoVax and the HVTN are currently preparing for very important Phase 2 human trials which are being planned for mid 2008
About GeoVax DNA & MVA Genetically Engineered HIV/AIDS vaccines:
-- Our DNA vaccine "primes" immune responses & MVA vaccine "boosts" immune responses against the AIDS virus in vaccine recipients
-- DNA and MVA vaccines are both genetically engineered vaccines expressing over 50% of the AIDS virus components in the vaccine recipient and can not cause AIDS
-- Protected 22 of 23 (96%) non-human primates against AIDS for over 31/2 years
-- Are manufactured & tested under GMP/GLP -- EMEA (EU) and FDA guidelines
-- Satisfactorily completed 2 earlier HIV/AIDS vaccine Phase 1 human trials
-- Currently have 3 ongoing Human Trials
-- 1 was initiated in 2006, 2 in Summer 2007
-- GeoVax HIV/AIDS vaccines have been demonstrated safe to date in human trials
-- Demonstrate positive anti-HIV immune responses in majority of human vaccine recipients
-- Are in planning stage for large Phase 2 human trial scheduled for mid 2008
Safe Harbor Statement: All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these 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, 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. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Company's Securities and Exchange Commission filings and report.
SOURCE GeoVax Labs, Inc.