The following is a full transcript of an interview conducted with Geert Kersten, the CEO of CEL-SCI Corporation (AMEX:CVM), whose company just received FDA approval to proceed with a clinical trial of its H1N1 flu drug candidate, testing its effect on white blood cells of patients who are hospitalized. The biotech firm said it is working on the next phase of the study and is preparing the drug's follow-up regulatory application.
Your company has been making some incredible headlines and suddenly it appears that you are poised for a tremendous comeback not only as an important player in the H1N1 space, but also now that you've raised enough money to finally move into PHASE III studies for Multikine(r). Can you talk about that?
There has been a method to the madness. The way you build a company's valuation is by hitting milestones and it's all about credibility, credibility, credibility. Over the years I've learned a great deal. We've always been lucky enough to survive the hard times and I'm applying all of my lessons, having survived the downturn in the market, and we're now doing it the right way.
Investors like companies who put out a list of goals every quarter and then consistently hit them, so your formula may prove to be successful.
When it comes to our new work with the H1N1 treatment and the current pandemic we felt that even if the current virus doesn't mutate, there will still be a significant number of deaths related to it and every single year and there will be hundreds of thousands of people who will be fighting for their lives hanging on respirators. We gave a lot of thought to worse case scenarios, which fortunately many smart people in the government have been thinking about as well, but if one starts to think that vaccinations are going to completely eliminate the problem, they're not. Data shows that people are afraid of taking the vaccines and while we hope that they do, the vaccines may not work as well as planned given the current technologies or the virus may simply mutate- as it does with the annual flu virus- and then the vaccine will no longer work. So right now there are a lot of people out there who my think that will solve the problem, but it's not necessarily the case at all. Again, even if this extremely virulent virus doesn't change, there will still be a few hundred thousand people in just the United States who will be fighting for their lives and if it gets worse, then those numbers will also grow exponentially. So as of today, we know of no other effective treatment that will increase their chance of living through that episode. Some people who are getting really bad cases of it show symptoms that look very similar to the Avian flu.
Are you saying that your new treatment which just got expedited by the FDA is proposing to deal with that?
I can't go into all of the details, but yes. We are working hard to make that happen. As you can imagine, it's a great responsibility.
Why can't you go into more details?
The way I look at this one, patent protection is not enough. What we are dealing with here is a complete unmet medical need and if we show good data, then I think we can come to market faster than we can get patent protection. Now mind you, we have applied for patents, but that doesn't keep competitors off the market. You must have issued patents. So I can't go into too many details because you can be sure that in certain parts of the world, where it takes years to get a patent, if you publish your patent information anywhere, it's certain to be copied and we want to make sure our shareholders are protected from that.
We've seen some very responsive government groups and a very supportive FDA. They're all working with us very quickly and they are all going out of their way with the idea that we can establish a potential treatment for these hospitalized H1N1 patients. While that's not a population of 200 million, if you look at the presidential results from about a month ago, I believe they estimated about 300,000 people that are expecting to go into an ICU and up to 90,000 deaths- and that is just the United States alone.
We felt that it was fairly important that we try to offer something to help these people and everyone in the government has been very responsive to us. So what this means is that we are running on all cylinders to rapidly do this clinical trial.
No one knows what's going to happen down the road, but if there is still a great need and a good number of people dying due to this pandemic and you show good clinical trial success, then at the very least some limited type of approval is not out of the question. Especially if it's safe and it can significantly affect survival among these patients. If you're the only answer out there, wouldn't you favor a rapid approval?
Many other countries don't have the same stringent requirements for approving treatments, and many will be without adequate vaccine supplies. Is it fair to say that other countries may want this treatment as well?
Yes. One would assume that in certain parts of the world if you show good results in your clinical studies and safety, that you will end up selling the product.
Would you be able to even deliver upon that type of demand?
Of course, but we would be looking at partnering with those other governments in that scenario. As of now, we are the only company working on a product that could potentially help.
You also have to consider that the 'bad' evolution of this virus is most likely to happen outside of this country. In places where animals and humans live in close proximity 24 hours a day, and that's actually about two-thirds of the world, where the chicken and the pig and the people all live in the same house. That's where you're going to get re-assortment. We don't know what those death rates could be, but what you have from the current virus is high transmissibility in warm weather, which as you pointed out in one of your own articles, has not been seen before in any other flu virus. If it picks up something nasty from another virus and that person gets on a plane, well then suddenly CEL-SCI could be the most important company in the world because there will be no one else who has done any work on this at all. Everyone would come to us.
Is that helping you move things along as quickly as has been reported?
You have an unmet medical need and we have developed some key relationships that have allowed us to go much faster. This is officially a pandemic and the expectation among very knowledgeable people is that this isn't just going to go away. On the contrary, they feel that this will rear it's ugly head in a form that is much worse down the road.
And your treatment can deal with that uglier form as well?
Yes, but we can't say too much yet. It's definitely something that came about due to our previous work with the L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System) vaccine technology, which induces protection against infectious diseases, and i would point people to our work promoting immunotherapy for rheumatoid arthritis and induced immunity against HIV.
So how quickly will this all happen?
It's already happening very quickly. If you went by the normal mechanisms, you would do lots of long animal studies and toxicology studies and so forth. We have a very different angle, which again, I can't talk about in great detail. Actually, I'm not able to even if I wanted to. Because of this great urgency, different rules are at play when it comes to vaccines and different rules are being applied to us also. Again, we have nothing but very positive things to say about our relations with the FDA. They have been incredibly responsive. They get it and that can only be beneficial for all of us involved with these developments.
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