January 15, 2013 at 16:24 PM EST
GeoVax Labs Releases Update Letter to Shareholders

Robert T. McNally, Ph.D., President & CEO of GeoVax Labs (OTCQBGOVX), along with David A. Dodd, Chairman of the Board, today issued the following update letter to shareholders:

Dear Fellow Shareholders,

Since our last shareholder update letter in May 2012, we have continued the steady progress of the clinical development of HIV/AIDS vaccines for both therapeutic and preventive applications. As we begin a new year, we are pleased to provide you this brief update on recent developments at GeoVax and our plans for 2013 and beyond.

Therapeutic HIV/AIDS Vaccine

As we have noted before, of the 1.2 million Americans infected with HIV, only 30 percent have successfully suppressed their infection using drugs. Thus, there is a need for simpler therapies to control HIV infections.

  • Our ongoing Phase 1/2 "treatment interruption" clinical trial, investigating the use of our vaccines for treatment of individuals already infected with HIV, completed enrollment at the end of 2012. This trial is designed to assess whether our vaccine is safe and immunogenic (i.e. induces immune responses) in individuals who have controlled their infections using oral drug medication. Following vaccination, the trial includes a short period of drug-interruption to evaluate the ability of the vaccine to control the infection in the absence of continuing drug therapy. We anticipate having meaningful data of this program later this year.
  • Planning is underway for our second therapeutic trial to begin in mid-2013. This Phase 1 trial will investigate the use of our vaccines in combination with standard-of-care drug therapy in HIV-positive young adults. We expect this trial to be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), a program supported by the National Institutes of Health (NIH). Because of the mechanisms by which current oral drugs work, if the virus is in latent phase (non-replicating), the drugs are not effective, thus it is impossible to totally eradicate the virus. There is hope for a combination approach using the patient's own immune system stimulated by the vaccine, together with oral drugs to eradicate the virus -- thereby potentially offering a cure.

Preventive HIV/AIDS Vaccine

Although success with a therapeutic program would contribute to improved patient care, prevention still remains the number one objective of national vaccine programs. It is worth repeating that, for the last two decades in this country, the incidence of new HIV infections has remained virtually unchanged at 55,000 new infections annually. The press has heralded stories about the use of oral medication taken on a daily basis as the new means for prevention. What they fail to disclose is the cost and, in some cases, medical side effects associated with this therapy. Human nature, being what it is, tends to be inconsistent in adhering to such a regimen. Throughout recent history, eradication of viral infections has been accomplished through vaccination.

  • The Phase 2a trial (HVTN 205) of our preventive HIV/AIDS vaccine has been completed. Results of this trial were presented in September by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed our Phase 1 results, with our vaccines demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. We expect formal publication of the full study results in mid-2013.
  • Patient enrollment was completed in December for the Phase 1 trial testing the safety of our second-generation preventive HIV/AIDS vaccine. Preclinical testing of this vaccine yielded superb results, with a 90 percent reduction in infection (per exposure) which translated to 70 percent of vaccinated animals being protected against 12 repeated, highly virulent, rectal challenges with a simian homolog of HIV. Based on these results, this is the version of our vaccine we plan to take directly into a Phase 2 efficacy trial in high-risk individuals. We expect the Phase 1 trial to be completed in the second half of 2013, setting the stage for a Phase 2 trial.
  • Discussions and planning with the HVTN for the Phase 2 efficacy trial are underway.
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