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GeoVax Labs, Inc. (GOVX-OTC: BB) |
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October 31, 2008 Issue |
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The Most Powerful Name In Corporate News and Information. |
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Focused On Developing A Vaccine To Treat Diseases Caused By HIV-1, GeoVax Is Preparing To Enter Phase 2 Clinical Trials With Their DNA Vaccine, Which Also Has An MVA Component As A Booster |
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Company Profile:
GeoVax Labs, Inc. is a
biotechnology company, established to develop, manufacture, license and
commercialize human vaccines for diseases caused by HIV-1 (Human
Immunodeficiency Virus) and other infectious agents. GeoVax's AIDS vaccine
technology is the subject of 20 issued or filed patent applications. GeoVax
AIDS vaccines are designed for use in uninfected people to prevent Acquired
Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should
the person ever become infected. GeoVax AIDS vaccines also may be effective
as therapeutics (treatment of people already infected with AIDS virus).
Studies evaluating these vaccines in HIV/AIDS infected individuals are in
the planning stage.
GeoVax's core AIDS
vaccine technologies were developed through a collaboration of colleagues at
Emory University's Vaccine Center, the National Institutes of Health (NIH),
The Centers for Disease Control and Prevention (CDC) and the GeoVax team. GeoVax AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health [NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant awarded in late 2007.
Our goals include: developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting phase 1, 2 and 3 human trials for vaccine safety and effectiveness and obtaining regulatory approval of these vaccines in the USA and specified international markets.
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Healthcare |
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GeoVax Labs, Inc. |
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Dr. Robert McNally graduated with a Ph.D. in Biomedical Engineering from the University of Pennsylvania and has over 28 years of experience in academic and corporate clinical investigations, management, research, business, quality and regulatory affairs.
Dr. McNally: “Quite simply, the vision of GeoVax is to bring a preventative and therapeutic (treatment) AIDS vaccine to the market place. That is exactly our vision and our mission.”
CEOCFO:
Where are you in the process?
CEOCFO: What is it about your vaccine that holds promise? Dr. McNally: “GeoVax uses an innovative combination of a DNA vaccine boosted by a MVA vaccine. The DNA primes the immune system and the MVA boosts it. GeoVax’s two-component vaccine follows a protocol where a total of four injections, two of each component, are given a number of weeks between each injection. For the DNA component of the vaccine you take pieces of the AIDS virus, portions of its DNA, and you insert them into a bioreactor fermentation system to create the vaccine which will prime the immune system. The MVA (Modified Vaccinia Ankara), which is a dead smallpox vaccine, is used as a backbone for the “boost” portion, then again incorporating pieces of the DNA from the AIDS virus. By having these two components, the DNA/MVA, we are attempting to boost the immune system as well as T cells. T cells seek out and kill off any HIV virus that might be in the system. The immune system is then able to ward off any kind of infection. If you are trying to create a preventative type vaccine, you want an immune system that is ready with antigens which will prevent the HIV virus from being able to replicate. If you use it as a therapeutic to treat someone already HIV infected, trying to prevent the progression of the HIV to full-blown AIDS, and eventual death, then you need a vaccine that has the propensity to increase the T cell response of the immune system. GeoVax’s vaccine does both of those things, it builds up antibodies as well as T cell response.”
CEOCFO: Is it difficult to get people to sign up for your trials? Dr. McNally: “The interesting thing about this is because our government has taken such a serious view of this epidemic, worldwide in scope, they have taken it upon themselves to fund the clinical trials. The trials are run by the HIV Vaccine Trials Network (HVTN), which is a division of the National Institutes of Health, based in Seattle, Washington. They conduct trials on a worldwide basis; the phase 2 trial that we are about to initiate will use ten different sites in the US and two in Peru. They have been doing this for ten or fifteen years and have trial sites already established around the world to test a whole variety of oral medications as well as vaccines. The sites develop techniques to recruit volunteers who were, in our case, doing safety studies. These volunteers do not have the HIV virus at the time of the study and they are willing to sign up. Honestly, it is the responsibility of the HVTN to find and recruit these individuals. It usually takes about a year to complete enrollment of a trial. Not only is willingness an issue, participants also must meet a variety of health and safety criteria and be free from the AIDS virus before they are accepted as a participant in the preventive trial. I am under the impression that that process has run rather smoothly to date.”
CEOCFO: What is the timetable? Dr. McNally: “You are looking for ultimate success in a vaccine. The trail behind us is littered with the bodies of many large pharmaceutical firms that have tried and for one reason or another have not been very successful. Looking forward, I think the way to answer your question is to say that a successful vaccine is going to come in stages. It is a very difficult disease to control. Right now to think that one vaccine is going to be the ultimate answer is not realistic. What is going to happen is you are going to get a vaccine that will be effective in a certain percentage of the population under certain conditions and for a certain strain of the virus. Based on that information, people will build other versions of the vaccine. It is similar to the early days of flu vaccines; they did not work very well until you had exactly the right kind of strain. Because the virus sometimes morphs into different things, the vaccines are not necessarily as effective as you would want. The answer for GeoVax though, and ultimately for an AIDS vaccine, is it is going to take many years just as it did when scientist were developing polio vaccines, all of which were not fully successful. Even the current polio vaccine is not 100% effective. It is only about 70% effective for the general population.
For GeoVax, the answer will be in the proof of
concept and the road to that is probably just a few short years away. As
previously mentioned, we have a version of the vaccine which is to prevent
people from coming down with AIDS. This would be for high-risk individuals
that engage in high-risk behavior or work in hospitals and medical groups
where there is a certain risk of contracting AIDS. There is also a
therapeutic vaccine, which will be administered as treatment to patients
already infected.
When you inoculate a group of the population against a virus, for example, the flu virus, and then you try to analyze how many people didn’t get the flu because they had the vaccine, you have to verify a certain percentage of people were even exposed to the flu. If you lived on an island somewhere and had no way of becoming exposed to the flu, you do not know if the vaccine worked or not. So, in order to perform an accurate testing of a vaccine, you have to inoculate hundreds and sometimes thousands of subjects in order to be able to get a statistically relevant number to know if your vaccine is really working. This process takes a long time. You cannot vaccinate someone then encourage risky behavior in order to prove the successful nature of your vaccine. You must let folks go about living their normal life. Statistically you know there is about 3% of the population that would engage in some kind of risky behavior, then do your statistics based on that data. When you put it in patients who already have the HIV virus and are currently on available oral medications, this is a group where we can get data relatively quickly – within a couple of years. I think once that proof is available then GeoVax is going to see a huge influx of attention given to its vaccine. The world is waiting for a crack in the door. They will see that some kind of success is possible and we have as good a shot at that success as anyone else. If it is true then we will not have to complete all those clinical trials. Our exit strategy is primarily going to be to license it out to large pharma.”
CEOCFO: What is the financial picture like for GeoVax, and do you need more money to proceed? Dr. McNally: “One can always use more money, but actually we are rather stable. We have cash on hand and besides the $15M grant from our government, we also have an investment arrangement that was consummated in the spring of this year from Fusion Capital, which allows us to draw up to $10 million. Being a relatively small company we are very judicious about how we spend funds. Since we do not have to pay for our own clinical trials, we only pay for staff and the development and commercial production of our two vaccines. Once vaccine is manufactured, we then turn it over to the government for testing in the trials. So, we can live on current cash flow for many years.”
CEOCFO: You have a long history in the industry; why are you with GeoVax today, and how has your background helped the company? Dr. McNally: “I personally came on board in April of this year. I have been a serial entrepreneur through most of my life. A good portion of it was spent in clinical trials in the human heart valve arena. So I have a background of clinical trials in regulatory and that is the mode that GeoVax is in now. Those are the hurdles that we as a company have to get over to bring this product to market. My skill set is understanding what is involved in those trials and trying to shorten them up as much as possible so that we do not spend our whole lifetime spending money trying to get through clinical trials. We want to see some light as quickly as possible, be able to license out this product and make it useful for mankind. I know that it is a trite phrase to use, but that really is the motivating factor of why GeoVax is around. That is our business, developing an AIDS vaccine, which is what we do day-in and day-out.”
CEOCFO: Under the best of times there are many places to put one’s money; under the current economic climate potential investors are even more choosy; why should potential investors look at GeoVax? Dr. McNally: “It is the whole market potential; right now there is no approved AIDS vaccine. The number is somewhere in the three billion dollar per year range for a first generation AIDS vaccines. That is a significant feedback especially when you think about it from a licensing arrangement for a company like GeoVax. I cannot predict what the potential would be per share basis, but there is a huge potential since this is a worldwide problem with worldwide interest and worldwide investment. That is why it is going to require some large pharma to be able to take it over and bring it to market. The financial feedback on a per share basis should be significant.”
CEOCFO: What should people remember most about GeoVax?
Dr.
McNally: “There
are a lot of naysayers out there thinking that there is never going to be
success for a vaccine, but the truth of the matter is that there is
potential and it will be developed very soon – sooner than most people feel.
In the next few years, we will know if the vaccine is really going to work
in AIDS infected patients. It is one of those things that if there is a
product, as a country, we cannot afford not to try to do something for this.
There are 33 million people in the world living with AIDS and an additional
two-and-a-half million become infected every year. In addition, about 2.1
million people die every year from this disease. Something has to be done
and just taking oral medications is not the answer to this worldwide
scourge. A better method of prevention and treatment must be found. When you
think of it as not just the death rate of people who have this disease, but
as the cost of maintaining life whether they are in the US or a 3rd
world country, the cost to the healthcare system within those countries is
enormous. AIDS is probably the single number-one costliest disease on the
face of the earth and GeoVax has a good chance of being, if not the complete
solution, at least part of the cure.” |
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“When you think of it as not just the death rate of people who have this disease, but as the cost of maintaining life whether they are in the US or a 3rd world country, the cost to the healthcare system within those countries is enormous. AIDS is probably the single number-one costliest disease on the face of the earth and GeoVax has a good chance of being, if not the complete solution, at least part of the cure.” - Dr. Robert T. McNally Ph.D. |
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