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ATLANTA, GA -- (Marketwire) -- 03/11/13 -- GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biotechnology company developing innovative, patented HIV/AIDS vaccines, today announced its financial results for the year ended December 31, 2012 and provided a business update.
"GeoVax continues its successful, steady progress with the clinical development of HIV/AIDS vaccines for both preventive and therapeutic applications," said David Dodd, GeoVax's Chairman of the Board. "With generous support from the National Institutes of Health (NIH) in the form of both research grants and clinical trial support, our preventive HIV/AIDS vaccine has advanced to a leadership position, and is currently the only vaccine candidate being considered for efficacy trials for the clade B subtype of the HIV virus prevalent in the Americas, Europe, Australia and Japan."
The following table reflects the current development status of GeoVax's HIV/AIDS vaccine candidates:
ClinicalVaccine TrialCandidate Indication Stage of Development SponsorClade B Vaccines (Americas, Western Europe) Clinical - Phase 2aDNA/MVA Prevention completed NIH/HVTN Prevention (2nd-DNA-G/MVA generation) Clinical - Phase 1 NIH/HVTN Planning - Phase 2 efficacy NIH/HVTN Therapeutic (treatmentDNA/MVA interruption) Clinical - Phase 1/2 GeoVax Therapeutic (drugDNA-G/MVA combo) Planning - Phase 1 NIH/IMPAACTClade C Vaccines (South Africa, India)DNA-G/MVA Prevention Research/Preclinical n/aDNA-G/MVA Therapeutic Research/Preclinical n/a
Clinical Development Highlights:
•Preventive Vaccine - Phase 2a Trial. The Phase 2a trial (HVTN 205) of GeoVax's preventive HIV/AIDS vaccine has been completed. Results of this trial were presented in September 2012 by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed the Phase 1 results, with the GeoVax vaccine demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. The Company expects formal publication of the full study results by the end of 2013. •Preventive Vaccine (2nd-generation) - Phase 1 Trial. Patient enrollment was completed in December for the Phase 1 trial testing the safety of GeoVax's second-generation vaccine (GM-CSF adjuvanted). 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. GeoVax expects the Phase 1 trial to be completed in the second half of 2013. •Preventive Vaccine (2nd-generation) - Phase 2 Efficacy Trial Planning. Pending successful outcome of Phase 1 testing of the second-generation vaccine, GeoVax expects to advance this version of its preventive vaccine into Phase 2 efficacy testing in high-risk individuals, expected to begin in 2014. The Company is currently in discussions with the HVTN regarding protocol development and anticipates knowing more about the trial design and the government funding consortium in late 2013. •Therapeutic Vaccine - Treatment Interruption Study. The Company's ongoing Phase 1/2 "treatment interruption" clinical trial, investigating the use of its vaccine for treatment of individuals already infected with HIV, completed enrollment at the end of 2012. This pilot trial is designed to assess whether the 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. GeoVax expects to see data readouts from this study during 2013, which might indicate the potential use of its vaccines to treat HIV infection, either as a standalone therapy or in conjunction with an oral drug regimen. •Therapeutic Vaccine - Drug Combination. Physician acceptance of a therapeutic HIV vaccine is increasingly being discussed as a combination therapy for HIV-positive individuals. By maintaining the standard oral drug medication and adding a vaccine, the medical community would be delivering the best possible care. In this regard, GeoVax is collaborating with the NIH and planning is underway for a second therapeutic clinical trial to begin in mid-2013. This Phase 1 trial will investigate the use of GeoVax's vaccine in combination with standard-of-care drug therapy in HIV-positive young adults. The Company expects this trial to be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), a program supported by the 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.
