ATLANTA, Jan. 9, 2012 /PRNewswire/ -- Robert McNally, Ph.D., President and CEO of GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), today issued the following letter to shareholders:
Dear Fellow Shareholders,
At the start of a new year, it is important to acknowledge all that we have accomplished over the past year, but it is even more crucial to focus our energies on the challenges and opportunities awaiting GeoVax in 2012 and beyond.
Here is a recap of our recent achievements, which have put the company on course for a very successful future. During 2011, GeoVax achieved steady progress in developing our HIV/AIDS vaccines and continued to lay a solid foundation for continued clinical and corporate success. While we are pleased with our results, our goal for 2012 is to achieve even greater and more timely progress.
Therapeutic Vaccine Program
We continue to make progress in our Phase 1/2 clinical trial for our HIV/AIDS therapeutic vaccine. The primary goals of the trial are to document the safety and immunogenicity (e.g., "immune response") of the vaccine in HIV-diagnosed patients with well-controlled infections. To accelerate enrollment in the trial, we added two clinical sites, the University of Alabama, Birmingham and the AIDS Research Alliance in Los Angeles. These sites join our initial site in Atlanta that is being run by ARCA (AIDS Research Consortium of Atlanta). In December, we announced inoculation of the first participant in this clinical program. Our goal is to have full enrollment by the end of 2012 and to be generating meaningful data in 2013. If the data are encouraging, this program will likely be expanded into a larger Phase 2 clinical trial. The successful application of our vaccine among already infected patients would represent a significant addition, and potential alternative, to the current antiviral drug therapy that is required for the remainder of a patient's life. Current estimates of the potential revenue value of such a product are in excess of $4 billion annually.
Preventative Vaccine Program
We are extremely fortunate to have the U.S. National Institutes of Health (NIH)-supported HIV Vaccine Trials Network (HVTN) continuing to conduct and fund our preventative vaccine trials. During 2011, several milestones were accomplished: (a) the publication of the results of our phase 1 clinical trial involving 120 participants, (b) the completion of enrollment of our phase 2a trial involving 300 participants and, (c) preparations for launching human clinical testing of the GM-CSF-adjuvanted form of our vaccine.
In the non-human primate model, the adjuvanted vaccine, which co-expresses GM-CSF in the DNA priming component, has shown outstanding and long lasting prevention (not just control) of infection. Because of its superior ability to prevent infection, our plan is to take the adjuvanted vaccine into efficacy trials launched as soon as late 2013.
Last month, it was announced that an application for FDA approval is being sought for a once-daily drug to reduce the risk of HIV infection among uninfected adults. While this made headlines and is a wonderful step toward the prevention of HIV infection, this is not a long-term practical solution to prevent infection. Medication and physician costs, side effects and patient compliance continue to be significant issues that such a drug regimen doesn't adequately address. Although you will read that individuals can achieve 73% protection if they faithfully take this drug, required strict adherence to the necessary prescribed drug therapy is rare. Once a vaccine is available, this method of prevention will no longer be an attractive option. Similar to the market value for a therapeutic vaccine, current market estimates for a preventative vaccine exceed $4 billion annually.
An article in Nature published this month by researchers at Harvard Medical School and the U.S. Military HIV Research Program heralded a preventative vaccine that gave protection in non-human primates, a result similar to what GeoVax published earlier last year. This report confirmed the prime-boost approach plus the use of similar genetic material in the vaccine to induce a protective immune response. In essence, they have validated our concepts and added some good news to the field. Results like this give the industry hope that an effective HIV vaccine is not far from reality and bolster our confidence that we are on the right track.
Financing and Corporate Development
We continue to benefit from tremendous financial, operational, and technical support provided to us by the NIH and the HVTN. The HVTN, funded by the NIH, is the largest worldwide clinical trials network dedicated to development and testing of promising HIV/AIDS vaccines. To date, the HVTN has conducted and funded all of our clinical trials for the preventative version of our vaccine. In addition to this support from the HVTN, we are the recipient of a $20 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant from the National Institute of Allergy and Infectious Disease (NIAID). This five-year grant spans a period from September 2007 through August 2012, providing financial support for the development of the GM-CSF adjuvanted version of our preventative vaccine.
While we are deeply appreciative of the generous governmental support we receive, it does not cover the cost of all of our activities. Hence, fundraising will continue to be a primary and critical focus for 2012, as it was in 2011. Through our efforts during 2010 and 2011 we have developed numerous contacts and raised our exposure profile among potential institutional investors which we believe will benefit us going forward. In addition to our equity financing efforts, we will continue to seek out additional opportunities for non-dilutive financing through governmental sources.
A little over a year ago we announced a "changing of the guard" in the leadership of our Board of Directors. Don Hildebrand, one of the founders of GeoVax who served as Chairman of the Board since our Company's inception, made the personal decision to step down from this position. Succeeding Don as Chairman of the Board is David Dodd, who had joined our Board of Directors in early 2010. In the period since he assumed the role of Chairman, we have benefited from his leadership and involvement. In summary, GeoVax has enjoyed steady progress over the past 12 months and we anticipate continued success in the coming year.
I am privileged to have the opportunity to work with the highly dedicated team at GeoVax. Our focus and goal is to achieve meaningful success with the development of our vaccines as soon as possible, providing the opportunity to proceed toward FDA submission and subsequent approval.
Thank you very much for your continued support,
Robert McNally, Ph.D.
President and CEO
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing of these vaccines under GMP/GLP conditions (FDA guidelines), conducting clinical trials for vaccine safety and effectiveness, and obtaining regulatory approvals to move the product forward. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported Phase 2 testing in an ongoing, fully enrolled, 299 participant trial in North and South America. GeoVax is also enrolling volunteers in a Phase 1/2 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its 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, GeoVax will be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
The Investor Relations Group:
Erika Moran, Investor Relations
Janet Vasquez, Public Relations
|SOURCE GeoVax Labs, Inc.|
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