CEO of GeoVax Discusses His Firm's Leading HIV Therapeutic Vaccine Candidate Print E-mail
By Staff and Wire Reports   
Tuesday, 14 August 2012 09:05
icon_ceoexclusiveGeoVax Labs Inc (OTCBB:GOVX) is an emerging biotechnology company engaged in the development of human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents. The company was established in 2001 with a mission to develop, manufacture, test and license vaccines for prevention of significant human diseases. Its goals include: developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting several human trials for vaccine safety and effectiveness and obtaining regulatory approval of these vaccines.

GeoVax Labs has developed both preventative and therapeutic vaccines for HIV/AIDS. It is mainly focused on the development of AIDS vaccines comprising the major HIV-1 subtypes (A, B and C). These vaccines can be used alone or as combinations depending on a local infection. When administered in series, its AIDS vaccines induce strong cellular and humoral immunity (protection) in non-human primates against multiple HIV-1 (AIDS virus) proteins. This suggests that the company's vaccines will provide protection against the development of AIDS in HIV-1 virus infected people.

Question: Why are you so enthusiastic about the state of HIV/AIDS vaccine research in 2012?

Bob McNally CEO GeoVax: The industry is starting to show success in being able to control the virus. In human trials, Sanofi Aventis was able to demonstrate 30% protection against the HIV virus. While 30% is not sufficient to be commercially viable, it opened the possibility for improved vaccines by other companies such as GeoVax. In our own preclinical trials, with an adjuvant added to our vaccine, we have demonstrated 90% per exposure efficacy, some of the best data in the industry.

Question: The theme of the AIDS 2012 conference was “Turning the Tide Together.” Do you think we are indeed close to turning the tide on the AIDS epidemic, and if so, in what ways?

Bob McNally CEO GeoVax: The tide has turned in several ways. First, the oral medication used to treat individuals who are HIV positive work very well. Life expectancy for this population is close to normal. Having said this, we still need to be cognizant of the high cost and frequent side effects from taking these drugs. Second, the oral medication can also be used to prevent infection, but again the cost is considerable ($12,000 per year) and compliance will continue to be an issue. Vaccines for prevention have begun to show a benefit and will materialize first, but clinics are also interested in the potential for therapeutic vaccines to be used with the oral medication in HIV-positive individuals. Here the anticipation is the virus could be eliminated or at least result in improved control.

Question: Why is it such a challenge for biotechs such as GeoVax to attract funding for what is clearly a vitally important type of research and development—namely, more effective HIV/AIDS vaccines?

Bob McNally CEO GeoVax: There are several reasons why funding is difficult, not the least of which is the poor record of other companies that have failed in their attempts to have a viable vaccine.  Another reason is the length of time required until a licensing event occurs; many investors would rather not wait that long.

Question: How did the RV144 trial in Thailand, which in 2009 demonstrated the first evidence of vaccine-induced efficacy, help re-energize the drive toward better HIV/AIDS vaccines?

Bob McNally CEO GeoVax: Everyone likes success. This was the first trial to show the potential for success. While 30% protection will not result in a commercializable product, it proved prevention could be accomplished with a vaccine. In addition, based on having some success, the scientific community can now build on knowing what portion of the immune system should be stimulated and the type of vaccine vectors that are worth pursuing.

Question: What is the most important thing that various at-risk populations should keep in mind regarding the current state of HIV/AIDS vaccine research and development?

Bob McNally CEO GeoVax: They should know that vaccines are still a few years away from the clinic. GeoVax has the leading preventive vaccine candidate for the version of the virus prevalent in North America and Europe. This vaccine will be entering a phase 2b efficacy trial starting early 2014.

Question: GeoVax’s vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. What is the current status of your preventative and therapeutic vaccines, and what comes next?

Bob McNally CEO GeoVax: The same two vaccine combination can be used both as a preventive and therapeutic vaccine. The preventive vaccine is the leading candidate for North America and will enter a large 4,200-person phase 2b efficacy trial in early 2014. This is the only vaccine currently being considered for efficacy trial. The therapeutic vaccine is currently enrolling HIV-positive individuals for a treatment interruption safety trial and as a first opportunity to control the virus. Another therapeutic trial will start in Q1, 2013 where the vaccine will be given to HIV-positive individuals who will continue on their standard-of- care oral medications. The National Institutes of Health (NIH) is sponsoring the trial in anticipation that the combination therapy will lead to a potential cure or eradication of the virus from infected individuals.

Question: What are the biggest challenges facing your firm?

Bob McNally CEO GeoVax: Despite tremendous financial support from the NIH for research and clinical trials, the company, like any biotech, can still use funding for operational support.

Question: Tell us where your company stands financially. 

Bob McNally CEO GeoVax: GeoVax is an OTC company with a market cap of roughly $15 million. We have had the benefit of a $20 million grant from the NIH that was spread out over five years. This helped lower our burn rate to approximately $250K per month. Consequently we periodically raise funds through the equity markets or private placement.

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