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One Company Aims to Re-Purpose a Smallpox Vaccine to Battle HIV

Released:8/23/2010 10:40 AM EDT
Source: GeoVax Labs

Newswise - Researchers from The Wistar Institute recently reported that a human adenovirus called AdHu26, once thought uncommon, is not so rare after all. This could be bad news for scientists eager to use engineered AdHu26 human adenoviruses as vaccines against HIV and other diseases. In this approach, adenoviruses, which commonly cause respiratory-tract infections, are rendered relatively harmless before being used as vectors to deliver genes from pathogens, which then stimulate the body to generate an immune response. Yet studies show that a viral vector may be less effective if the vector is based on a type common in a population, because humans will have previously developed immunity to it.

"AdHu26 is considered by some to be rare in nature and thus there should be less pre-existing immunity. Dr. Hildegund Ertl [at Wistar] is claiming this is incorrect at least for certain human populations," says Mark J. Newman, Ph.D., Vice President of Research and Development at GeoVax Labs, headquartered in Smyrna, Georgia. In its quest for an HIV vaccine, GeoVax has turned for help to a poxvirus vector called Modified Vaccinia Ankara (MVA), originally developed as a safer smallpox vaccine.

"Since we no longer administer smallpox vaccine except to the military and a select group of first responders for the potential use of smallpox by bioterrorists and smallpox has been eliminated from the human population, the vast majority of people are not being exposed to vaccinia viruses, of which MVA is one," continues Dr. Newman. "Thus there is a lack of pre-existing immunity, at least in people who were born after 1971 when the universal use of the smallpox vaccine was discontinued."

Because of the difficulty raising antibodies that are capable of totally blocking natural HIV infections, the GeoVax vaccine approach has focused on raising cellular immune responses in addition to antibodies, which together should be better able to block and control the infections than either can alone. The company's vaccine proteins, which are inactivated proteins from HIV, are expressed in cells of the vaccinated person following administration of genetically engineered DNA vectored vaccines and live viral vector MVA vaccines. MVA was chosen, in part, because of its safety features but also because a sufficient amount of HIV genetic material can be inserted which supports the production of virus-like particles in cells.

These particles mimic immature HIV viruses and present the viral proteins to the immune system in the correct conformation inducing both cellular immune responses and antibodies. Testing using preclinical nonhuman primate models documented the utility of these vectors for inducing the desired types of immune responses. The company believes this novel approach may well succeed where the use of approaches that induce other types of immune responses may fail.

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About GeoVax Labs, Inc.

GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV
(Human Immunodeficiency Virus - that leads to AIDS) and other infectious agents. Our goals
include developing HIV/AIDS vaccines for global markets, manufacturing 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 tested various combinations and
doses of our DNA and MVA vaccines, their ability to raise anti-HIV immune responses, as well
as the vaccines' safety. Successful results from all 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 the FDA
granted permission to proceed with a Phase 1 therapeutic trial for individuals infected with HIV.
Long term, we expect that GeoVax will grant manufacturing and distribution rights in several
global markets in return for upfront fees, collaborative development agreements, and royalties on
sales and distribution revenues. Internal vaccine manufacturing and distribution will also be
considered by GeoVax. For more information, please visit www.geovax.com.

Forward-Looking Statements
Certain statements contained in this release, including those relating to postponement of the offering, as
well as statements containing words like "plans," "expects," and other similar expressions in this press
release or the Company's other public communications, are forward-looking statements that involve a
number of risks and uncertainties. All such forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially from those in the forward-looking
statements. These risks and uncertainties include, but are not limited to: the possible adverse impact on
the market price of the Company's shares of common stock due to the dilutive effect of the common stock
and warrants which may be sold in the offering, and the possible adverse effect of continuing unfavorable
market conditions, as well as other risks and uncertainties, such as those detailed from time to time in the
Company's Securities and Exchange Commission filings, including "Risk Factors" in the Company's
most recent Form 10-K.
Contact:

At The Investor Relations Group:
Investor Relations
James Carbonara / Jason Strominger
or
Public Relations
Janet Vasquez / Robin O'Malley
(212) 825-3210

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