Althea Technologies Contracted by GeoVax to Produce a Phase 2 AIDS Vaccine
6.20.2007 Althea Technologies Contracted by GeoVax to Produce a Phase 2 AIDS Vaccine
SAN DIEGO – June 20, 2007 -- Althea Technologies, Inc., a leading provider of innovative technologies and services for pharmaceutical development and manufacturing, announced today that it has been engaged by GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, to manufacturer its HIV-1 DNA (AIDS) vaccine. This vaccine will be utilized in GeoVax’s advanced Phase 2 human trials planned to start in early 2008. GeoVax chose Althea as the contract manufacturer for its DNA vaccine based on its extensive experience in the field of DNA vaccine manufacture and its regulatory compliance history.
GeoVax AIDS vaccines are designed to prevent development of Acquired Immunodeficiency Disease (AIDS) caused by the virus known as HIV-1 by vaccinating individuals prior to their infection with the AIDS virus. The GeoVax vaccine regimen employs a “prime-boost strategy.” Trial participants are administered the GeoVax HIV-1 DNA vaccine which “primes” the immune system followed by the GeoVax HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines deliver over 50% of the AIDS virus components but can not cause AIDS. Safety and immunological results from earlier as well as ongoing human trials have been very encouraging thus supporting planned acceleration of large scale Phase 2 clinical studies.
Summary of Human Trial Results
To date, ongoing GeoVax preventive HIV/AIDS vaccine human trials have indicated:
- Very acceptable safety profile in the 1/10th dose trial that began April 2006.
- 1/10th dose of GeoVax vaccine stimulates potential protective anti-HIV immune responses in up to 100% of vaccine recipients.
- Highly acceptable safety profile in an ongoing full dose trial started in September 2006.
- Full dose of GeoVax vaccine also stimulates excellent immune response
(complete data not yet available).
In the ongoing full dose trial, excellent safety data has been demonstrated in all volunteers who have completed the vaccine regimen. This trial enrolled 36 volunteers with 30 receiving GeoVax AIDS vaccines and 6 receiving a placebo. Enrollment for the full dose trial was completed May 25, 2007.
Don Hildebrand, CEO and President of GeoVax Labs Inc., commented, “We are very pleased with our decision to use Althea as the contract manufacturer for our DNA-AIDS vaccines due to their long and well known expertise in this arena. The manufacturing of these vaccines for GeoVax’s Phase 2 human trials is a very important step forward in our development plan and demonstrates our confidence in the future success of our AIDS vaccine program.”
Human trials utilizing GeoVax’s AIDS vaccines are being conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax’s DNA and MVA vaccines was also funded and supported by the National Institutes of Health and National Institute of Allergy and Infectious Diseases.
About Althea Technologies, Inc.
Althea Technologies, a leading San Diego-based pharmaceutical services firm, provides critical manufacturing and development services that support researchers worldwide in their advancement of novel therapies and efforts to apply new genomic information. Althea’s services include cGMP contract manufacturing of recombinant proteins, DNA-based therapeutics and vaccines, aseptic filling, and gene quantification using real-time PCR and gene expression analysis under GLP conditions. Additionally, Althea has introduced new services and technologies for the identification and development of genetic biomarkers with innovative programs such as the company’s proprietary Express Pathway℠.