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It's been a while since I've had an opportunity to address the stakeholders of Cellceutix. To put into perspective what's been happening, I think back to growing up in New England. There was a saying that if you don't like the weather in New England, just wait a minute. The process of drug development is a little like the New England weather. You just don't know what's going to happen from day to day and there are frequent changes as new information becomes available.
Since we last spoke, we've had a stock market crash, a new president in Washington and lots of bad news in the biotech and pharmaceutical industries. Despite these industry issues, however, this is an exciting time for Cellceutix as most of the unexpected things that have happened to the Company have been for the better.
Let's begin with Kevetrin™, our lead pipeline candidate. Job #1 was to file our patent application. While it took longer than we expected, this complex and far reaching patent is now filed with much broader claims than we imagined at the beginning of the patent process. We feel that we will have good protection for Kevetrin as well as the opportunity to work on some of the large number of novel molecules covered by the application.
We've also learned a lot more about our compound. We've thought all along that Kevetrin would be developed for the treatment of head and neck cancer. This is clearly an underserved market and our animal data showed that Kevetrin has good activity and potential synergy with radiation treatment. Recently, however, we've done several additional animal experiments with Kevetrin using drug-resistant lung cancer cell lines. These experiments, summaries of which you can see elsewhere on our site, indicate that Kevetrin may have surprising activity. Lung cancer, the worlds most prevalent cancer, is very difficult to treat with current therapies and, as a result, survival rates are not very good. Only 15% of patients survive for 5 years after diagnosis with lung cancer. With this in mind we are seriously thinking about shifting our development focus to lung cancer. There is great medical need here; one that can't be ignored.
In addition to these lung cancer studies, we've completed two acute toxicity studies and are nearing completion of pharmacokinetic/pharmcodynamic (PK/PD) studies. The toxicity studies do not show any unexpected issues and the PK/PD will be complete in the near future. At that point we'll be ready to ask the US Food and Drug Administration (FDA) for a pre-IND meeting. The goal of that meeting would be to understand exactly what remains to be done before filing an IND. For Cellceutix, filing an IND would be a major milestone.
While doing this work on Kevetrin, we've also been working on KM-133, our family of psoriasis compounds. We performed a series of chemical optimization exercises and selected three compounds for further testing. The results of these experiments should be available shortly.
Just as the variability of the New England weather forces its residents to be agile and flexible, the complexity of the drug development process forces Cellceutix to be similarly agile and flexible. The Company faces several challenges such as capital availability and the normal risks in new drug development. On the other hand, we have two very viable new drug development candidates in two quite different areas, both of which have a high level of medical need. We're very happy with this current state of affairs.
George W. Evans, JD, MBA
Chief Executive Officer
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