ATLANTA, GA--(Marketwire - Jan 15, 2013) - Robert T. McNally, Ph.D., President & CEO of GeoVax Labs (
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. 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.
Financing and Corporate Development
- Our relationship with the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH continues to be strong. 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.
- 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.
- 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.
We wish to once again thank our shareholders for their long-term and continued support.
Robert T. McNally
President & CEO
David A. Dodd
Chairman of the Board
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. 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 a Phase 1 study supported a Phase 2a trial that was completed in the 3rd quarter of 2012.
GeoVax's 2nd generation preventive vaccine is currently in phase 1 testing and is planned to progress to phase 2 efficacy testing, given safety and immunogenicity are as expected. Overall, the GeoVax vaccine, in various doses and combinations, has been tested in close to 500 humans. GeoVax is also enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.
HIV infection, which can lead to AIDS, is a pandemic that can affect anyone, regardless of race, gender, age, or sexual orientation. 33 million people are currently infected globally; it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, more than a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with HIV. Globally, HIV is the top killer among women of reproductive age. HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B and C. GeoVax vaccines are currently designed to function against clade B.
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.