|CEO: Cellceutix's leading drug candidate represents major breakthrough in cancer research|
|By Staff and Wire Reports|
|Tuesday, 26 July 2011 01:08|
Question: The latest news from Cellceutix announced a Notice of Approval for a clinical trial at a major cancer center. Can you elaborate?
The details will be disclosed in the coming weeks, but it is safe to say that the cancer center that has approved hosting the clinical trials was absolutely who we were hoping for. While it has taken a bit longer than it would have if we would have elected a smaller hospital, the prestige of this facility adds a great deal of validation to our belief in Kevetrin’s potential. It is a rarity that a small company such as ours would have the opportunity to have a trial at a world-renown cancer research center. That can only be attributable to the promising data that resulted from the preclinical trials. We are excited to share more information in the near future.
Question: One thing that seems to set Kevetrin apart from other cancer therapies is a breakthrough with p53. Why is this significant?
p53 is known as the “Guardian Angel” gene and a key component in regulating the cell cycle. In more than half of all cancers, the p53 has lost all or a portion of its function which allows cancer cells to run rampant. Researchers have known about the p53 correlation to carcinomas, but have yet been able to come-up with a solution to restore the function of p53. There was a class of drugs called “Nutlins” a few years ago that believed to hold promise, but proved to be genotoxic – meaning that the drug damaged the hosts DNA – so that quickly was realized as not a viable option. Kevetrin has proven to this point to restore p53 back to a normal status so it can do its job as master regulator and see to it that the cancer cells are destroyed without damaging any DNA. It is truly a major breakthrough in cancer research. We don’t know of any other pharmaceutical company that possesses, much less developed, a compound that can do what Kevetrin is doing with p53.
Question: The Cellceutix Chief Scientific Officer, Dr. Krishna Menon, has quite a background in cancer research. Could you tell us a bit more about him?
Actually, our whole team has amazing credentials. Dr. Emil Frei sits on our Advisory Board and holds a large list of accolades. Dr. Frei is widely-regarded as the “man who cured childhood leukemia” and currently sits as the Physician in Chief Emeritus at Dana Farber, Harvard University’s cancer center as well as recently being the recipient of a lifetime achievement award from the American Association for Cancer Research. Dr. Samuel Danishefsky is also an Advisory Board member and a globally-respected chemist and recipient of countless awards for his cancer research. Dr. Menon has an extensive background in the development of successful cancer drugs. He worked under Dr. Frei during his time at Dana Farber and eventually segued into a lead researcher in-vivo studies at Eli Lilly where he was awarded a Presidential Award for the key role he played in the development of Gemzar and Alimta, two of the most commonly-used cancer drugs still today. Dr. Menon’s holds Kevetrin’s potential in very high regard and given his track record, it certainly adds credence to the possibilities.
Question: With the potential of a major breakthrough in cancer treatment, have any major pharmaceutical companies contacted you regarding your research with Kevetrin?
We have been contacted by some of the biggest pharma companies in the industry. Our poster presentation at the AACR meeting was a huge successes with our booth being one of the busiest that we have ever seen at a convention. Even though we aren’t at liberty to disclose the names, we have issued statements announcing that Confidential Disclosure Agreements have been signed. In my experience, it is extremely rare for a major pharma to contact a company regarding any drug that is not yet in clinical trials, but we are in contact with several who appear quite interested in what we have in our pipeline. In fact, it is not just Kevetrin, we have also signed a CDA regarding KM-391, another compound of ours that we feel holds a great deal of potential as a next-generation treatment for autism because it addresses the core issues in the brain, not merely the symptoms as current drugs do.
Question: Because of the uniqueness of Kevetrin, a variety of opportunities could be presented with regards to the human trials that are not normally available for many biotechs. Could you share your thoughts on the possibilities?
That is exactly true that we may have some significant advantages being that Kevetrin is a new class of chemistry in medicine. One of the single, most important facts is that we will be getting our target audience in Phase I; something that typically doesn’t happen. Phase I is generally for testing safety of the drug, but because we will be getting terminal cancer patients, it provides us with the potential to show efficacy. If that happens, many windows of opportunity open with regards to applying for priority review or FDA Fast Track status which can exponentially expedite the pace of trials and possibly move us into advanced stage trials in the mid-term. We are very optimistic about being able to replicate some of our pre-clinical trials that have demonstrated tumor growth delay and reduction in tumor volumes across a broad spectrum of strains of cancer and are excited to get into the clinical trials to see if our contentions are validated.
Question: Clearly Kevetrin is your flagship compound and you briefly touched on KM-391. What else is in your pipeline?
In all honesty, we feel that our pipeline rivals many of our Big Board competitors. We have a total of 8 compounds in our portfolio including Kevetrin and KM-391. We have already conducted early research on KM-391 as an indication for the core issues of autism and have seen promising results. As Kevetrin moves into human trials, we will be turning our attention back to KM-391 as there is a huge area of unmet medical need in that arena and represents potentially billions in revenue. We also have a very promising psoriasis drug, KM-133, which is a small molecule that has shown very promising research as well. Our latest testing in a mouse model against a commonly-used treatment, methotrexate, demonstrated KM-133 outperforming the standard therapy with no reoccurrence of the psoriasis being shown. We will also be turning our attention back to KM-133 in the near term as well as we have received some very significant interest in it as well.