CellCeutix pharmaceutical company

Having passed the important milestone of our pre-IND meeting, it seems a good time to reflect on the last year for Cellceutix and to look ahead to the coming year. It is fair to say that we've come a long way. We believe that the coming year will be equally significant, if not more so.

At the beginning of last year, we were still figuring out which direction to take with our lead compound, Kevetrin (TM). We had some interesting data in head and neck cancer, but weren't sure if that was really the right way to go. Since then, we've filed our patent application, which covers Kevetrin and a large number of other related compounds. We've developed very interesting data in drug resistant lung, breast and colon cancer cell lines, which is encouraging given that these cancers are so difficult to treat. In fact, some of this data was presented at the American Association for Cancer Research (AACR) meeting in October. We've completed the synthesis of Active Pharmaceutical Ingredient under GMP conditions. And, after consultation with FDA, we've started the toxicity and safety pharmacology studies that will be needed for the IND filing.

In addition to this work on Kevetrin, we've completed an interesting experiment with KM-133, our compound for psoriasis, showing that KM-133 does better than methotrexate in reducing psoriasis and that psoriasis does not recur with KM-133. And we've acquired two new compounds, KM-732, for hypertensive emergency, and KM-391 for autism. Both areas are quite interesting from a development point of view. While hypertensive emergency is not a huge market, there have been few new treatments and there is a clear medical need. For autism, there is no proven treatment and there are few potential treatments in development. Given the increase in autism diagnoses around the world, there is obviously a huge need and a huge opportunity here.

Before we look ahead to the coming year, let's look at the pre-IND meeting itself to see what it is and why it's so important for a biotech company like Cellceutix. From the big pharma point of view, companies often look at pre-IND meetings as a waste of time--or worse. Maybe FDA will make a comment that will throw the program off-schedule and/or add to the cost. The companies feel that they know what to do and they don't risk much by going ahead and doing it. Given this, a lot of programs at big pharmas go forward without pre-IND meetings. The companies will defer asking for FDA input until later, perhaps even until the program is ready to enter phase 3.

With a smaller biotech company, it's different. While the company may well have experienced employees or advisors, it has probably done few programs as a team. And given the skittishness of investors in the biotech industry, going back to fix something after IND filing can be catastrophic. It makes perfect sense that a smaller company will want to get FDA input before the final pre-clinical protocols are locked into place. That way any comments can be addressed before the money is spent.

At Cellceutix, we decided to follow this approach and sought FDA input before the toxicity and safety pharmacology protocols were locked in. Since FDA had some comments, this proved to be the right strategy. The FDA's comments were really quite helpful, so we improved both our regulatory situation and our protocols. We're now completing the remaining studies. We're quite happy with the progress of the studies at our partner, Toxikon.

Over the coming months, we look forward to completing the remaining pre-clinical studies for Kevetrin. Assuming no negative surprises, we'll proceed from there to file our IND. Moving into clinical studies is not only a huge step forward for a biotech company, but it's a huge increase in complexity and cost. We'll spend most of our time in the coming year preparing for this quantum leap. We're working on arrangements with a phase 1 study site as well as putting together the resources to manage the study. We're also getting together the manufacturing of the formulation that will be used in the study.

It's going to be an exciting year. There's a lot on our plate, but we know what we have to do. We continue to be encouraged by our progress and optimistic about the future.

George W. Evans, JD, MBA
Chief Executive Officer