Filed Pursuant to Rule 424(b)(3)
Registration No. 333-180535
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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.
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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.
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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.
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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.
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Discussions and planning with the HVTN for the multistage Phase 2 efficacy trial are underway. We expect the study protocol to be developed this year, with trial commencement in 2014. GeoVax has the only vaccine currently being considered for efficacy trials in the Americas, which will give GeoVax a leadership position in developing a preventive vaccine for the clade B version of the virus prevalent in North and South America, Europe, Australia and Japan. One of our major goals for 2013 is to solidify the consortium of government and third-party financial support of this trial.
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In addition to the clinical trial support from HVTN (funded by the NIH), our vaccine programs have been supported by direct grants to GeoVax from the NIH. Most recently, the NIH awarded us a grant of $1.9 million to begin the extension of our vaccine technology to cover clade C HIV infections. This brings our total grant support from the NIH to $22.2 million during the past five years.
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Generous non-dilutive funding through government support does not cover all the costs for development of a vaccine. Fundraising continues to be a primary management focus for the coming year.
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We recently began a formal outreach program for discussions with larger pharmaceutical and biotech companies about potential collaborations with us on the commercialization of our vaccines. At this point, our objective with this program is to build the relationships and establish dialogue that may result in a future transaction.
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