ATLANTA, Aug. 7 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. , an Atlanta-based, biopharmaceutical firm (the "Company"), developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced its financial results and provided an operational update for the six months ended June 30, 2009.
Dr. McNally continued, "We recognize the lengthy process to shepherd a preventative vaccine through clinical trials and FDA approval. We therefore have initiated a secondary clinical pathway to develop our HIV/AIDS vaccine candidate as a therapeutic vaccine. The approval path for this project has a much shorter duration than our current program for the development of a preventative vaccine. We have already commenced protocol development for our first Phase 1 human clinical trials investigating the therapeutic vaccine approach. Our reassessment of the time required to gain approval from the FDA is such that we expect this trial to begin during the first quarter of 2010. Our plan is to produce data from our therapeutic vaccine trials in support of future capital-raising and corporate partnering efforts."
Review of Financial Results
Summarized financial information is presented below. Further information concerning the Company's financial position and results of operations are included in its Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission.
HIV/AIDS Background
HIV affects the entire globe and comes in a variety of subtypes. Clade B is the predominant subtype in North America where there are roughly 60,000 new infections each year. Globally, there are about 2.5 million AIDS infections per year, most primarily involving subtypes AG, B, and C. In 2007, UNAIDS reported 1.3 million people living with AIDS in North America and 33.2 million people living with AIDS worldwide. Presently, there is little to prevent HIV transmission other than education, circumcision, and condoms. It is obvious from the spread of the disease that these methods are not adequate. Existing treatments for individuals infected with HIV include anti-retroviral therapies that are effective but have serious medical side effects and are very expensive (upwards of $1,500/month). This cost is borne primarily by the individual and sometimes by third party insurance, local healthcare, federal or world health organizations. Development and distribution of an effective HIV/AIDS vaccine holds great promise. The GeoVax Vaccine would cost a fraction of the cost of current treatments and, to date, has not elicited serious adverse side effects in several human trials. A population vaccinated with an effective HIV-1 vaccine would be expected to significantly decrease the prevalence of AIDS over time.
GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.
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 limitation, risks detailed in the Company's Securities and Exchange Commission filings and reports.
SOURCE GeoVax Labs, Inc.
CONTACT: Robert McNally of GeoVax Labs, Inc., +1-404-727-0971,
rmcnally@geovax.com; or Investor Relations, Leslie Loyet, +1-312-640-6672,
lloyet@mww.com, or Media Relations, Nikki Snodgrass, +1-312-640-6732,
nsnodgrass@mww.com, both of Financial Relations Board, for GeoVax Labs,
Inc.
Web site: http://www.geovax.com/
