GeoVax Vaccine Only 5th AIDS Vaccine Moving To Phase 2 Human Trials

Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Feb 2008 - 0:00 PDT

email to a friend   printer friendly   opinions  

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), http://www.geovax.com, an Atlanta based biotechnology company, announced their HIV/AIDS vaccine is one of the select few to move forward into Phase 2a human trials by the HIV Vaccine Trials Network (HVTN), a network supported by the National Institutes of Health (NIH).

GeoVax's AIDS vaccine is believed to be only the fifth [5th] HIV/AIDS vaccine to be selected to move forward into Phase 2a human trials conducted by the HVTN. In contrast, it was approximately HVTN's 65th vaccine evaluated in Phase 1 human trials.

Most recently, GeoVax Senior Vice President of Research & Development, Dr. Harriet Robinson, and President, Don Hildebrand, attended a meeting with key HTVN officials in Seattle, Washington to plan and prepare necessary documents for the next phase of testing of GeoVax's promising HIV/AIDS vaccine, namely Phase 2a human trials designated as Protocol # HVTN 205.

Attended by over 20 HVTN personnel and key GeoVax personnel, this event included individuals instrumental in organizing and implementing human clinical trials designed to evaluate the GeoVax HIV/AIDS vaccine. The newly planned Phase 2 trials are tentatively scheduled to start mid-2008 and will involve up to 500 participants at several locations in the USA.

"We are delighted that our HIV/AIDS vaccine has been selected to move forward into Phase 2 trials. Our vaccine continues to demonstrate the promise of not only being safe but also effective at eliciting potentially protective immune responses," stated Dr Harriet Robinson, Senior Vice President, Research & Development at GeoVax.

"GeoVax is extremely pleased to have passed the significant hurdles required to move into Phase 2 trials. Only a handful of AIDS vaccines have reached the Phase 2 level of clinical evaluation with the HVTN, including the previously failed vaccines of Vaxgen and Merck," stated GeoVax President, Don Hildebrand.

GeoVax has completed two Phase 1 human trials evaluating its AIDS vaccines with excellent results and has three additional human trials currently underway. Due to promising results from these five trials the HVTN is pushing forward with plans for critically important and larger Phase 2 human trials.

GeoVax AIDS vaccine technology and composition are significantly different than the Merck & Co. Inc. AIDS vaccines that recently had their human trials halted due to safety and effectiveness concerns.

About GeoVax Labs, Inc.

GeoVax Labs, Inc. 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 AIDS 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 and may be effective as therapeutics (treatment of people already 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 have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN] based in Seattle, Washington. The 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. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by the National Institute of Allergy and Infectious Diseases (NIAID). The NIH provided additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant awarded in late 2007.

GeoVax DNA & MVA Genetically Engineered HIV/AIDS vaccines:

-- DNA vaccine "primes" immune responses & MVA vaccine "boosts" immune responses against the AIDS virus

-- Are both genetically engineered vaccines expressing over 50% of the AIDS virus components in vaccine recipients 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 [USA] guidelines

-- Satisfactorily completed 2 earlier HIV/AIDS vaccine Phase 1 human trials

-- Currently have 3 ongoing Phase 1 Human Trials - 1 was initiated in 2006, 2 in summer 2007

-- Have been demonstrated safe to date in human trials

-- Demonstrate positive anti-HIV immune responses in majority of human vaccine recipients

-- Are planned for mid 2008 Phase 2 trials based on success in previous HVTN conducted trials

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 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.

GeoVax Labs, Inc.
http://www.geovax.com

• Additional
• References
• Citations