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CEOCFO Monthly Analyst
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RNA
Technology…to re-program the
human cell
Biotechnology & Drugs, Sector:
Healthcare, AMEX: HE Hemispherx Biopharma, Inc. 1617 JFK Boulevard, Suite 660
William A. Carter, MD Interview conducted by: Walter Bank
Co-Publisher Introduction and career history of Dr Carter. I've had about 15 years experience as Senior Scientific Officer and CEO of Hemispherx Biopharma. This is a Biopharmaceutical company, which is engaged in new drug development for chronic diseases, especially those of the immune system and those that are chronic viral disorders. Prior to that I was a Professor and Chairman at various medical universities in the United States, including John Hopkins, Duke University and the State University in Buffalo. Essentially I underwent a transition in my career going from a professorial profession to a person who is trying to translate technology into new medical products. During my academic career I did the first clinical studies on Interferon, which became the first broad based anti-viral compound to be certified by regulatory agencies worldwide. It is presently the treatment of choice for over 20 major diseases. Ceocfointerviews: What I would like you to do now is to explain your company, talk about it, the lead technology, and then touch on the lead drug and product that comes out of that. Dr. Carter: During my academic career, we received many millions of dollars from National Institute of Health Grants, which allowed us to study the human immune system. This was specifically those components of the human immune system that seemed to be critical for fighting off virus infections. During this academic phase, we discovered some components of the immune system, which in our belief, could be tweaked to enhance in a manner that could produce a very beneficial anti-viral effect. As I mentioned in my introductory, my pioneering work with Interferon already led to one medication presently sold under different trade names. That was a very exciting break through and very significant commercial success because Interferon today sells over billions of dollars in the US. I found certain limitations in the Interferon affect, which basically had to do with some side effects that were quite bothersome, especially with people who suffered from hepatitis and also the duration of benefits were limited. Many patients would respond, but many times, after six to nine months the viral disease would recur. We began to see if there could be a different way to achieve the Interferon type effect, which was safer and more durable. This came and this led to a development to Nucleic Acid Technology. It's specifically called RNA technology. This is a way of actually triggering the body to produce its own Interferon instead of giving it as a drug. About 15 years ago, my colleges and I began to undertake animal testing and of course have to file for patents on this subject matter. To date we have over 350 patents issued worldwide on this RNA technology. RNA technology itself is a lengthy word. What it really refers to is molecules that actually have the ability to program the cell to do something that the human cell would otherwise not be doing. The human cell is not on my computer. In the computer you have a hard drive, which has this analogy, like DNA in a cell, and then you have software programs in the computer. RNA drives software programs in the human cell, which is the technology that we have been developing. So essentially, we have been developing a series of software’s, which allows us to tweak the human immune system. This led to a series of drugs, including a drug named Ampligen, which is one of our flagship drugs being developed for chronic virus infections. Another drug called Polyadenur, which is being developed for hepatitis and then we developed a series of compounds that could be taken in a pill like form and we call them Oragensä. In fact, we ended up with 50 different drugs, which were basically behaving as software for diseased human cells, especially for the diseased human cells of the immune system. Then we had to identify diseased targets that we could test this scientific principal. The diseases we identified were Hepatitis B, HIV, and Chronic Fatigue Syndrome, which is associated with a Herpes Virus. For each of these disease categories we initiated a series of clinical tests. As you know, when you do clinical testing there are phases, such as Phase 1, Phase 2, and Phase 3, and if your phase 3 is successful then you are allowed to go forward and apply for what is called a "New Drug Application". We are basically in the process of conducting clinical tests across a broad base of disorders, including the disorders I just mentioned. One of the reasons we have chosen these disorders is not only because these disorders have a profound medical impact on the person suffering from it, but. they have a huge societal impact. These diseases drain the resources of society and therefore, create a massive drag on the medical economy. We felt if we could address these diseases we would not only address the patients involved, but also their families and society at large. With one of these disorders, Chronic Fatigue Syndrome, we have actually advanced to phase 3 level. We are conducting definitive and conclusive tests in this phase. In the US for example we are utilizing more than two-dozen medical centers across the country and special clinics that have been established where we provide our drug in that setting. Patients either receive that drug or a dummy drug called a placebo. That allows us to have the best scientific insight. Particularly, these studies last for about one to two years. We expect some time, in the coming months, to analyze the data from our phase 3 studies. We've done an earlier phase 3 study a few years ago and the results were quite encouraging to us and were published in a review journal. Ampligen is the drug I am referring to. This is for Chronic Fatigue Syndrome. Ceocfointerviews:
Is that the drug, which is in Phase III? |
