KM 3
Company Overview
Cellceutix Pharmaceuticals, Inc. is an emerging bio-pharmaceutical company in the business of developing small molecule therapies in areas of unmet medical need. Our primary efforts are in cancer and inflammatory disease. We intend to spend most of our time initially on our lead product, Kevetrin, which is being developed for drug-resistant cancers. We've recently announced some exciting results in animal models of multi-drug resistant lung cancer.
-
Click links to view summary of data.
We'll focus on developing the highest quality data and intellectual property to support Kevetrin so we can move it as quickly as possible along the regulatory pathway. We have five other exciting compounds in our pipeline that we will progress as resources become available.
Business Strategy:
Our business strategy is simple. We want to make the most of what we have and use it to benefit patients. Benefits for patients will translate into benefits for investors.
We think "Compounds for Cures" sums it up pretty well. We have an exciting pipeline of products with the potential to help patients and an experienced management team that can move these products forward. We'll start with Kevetrin. We have several studies we need to do before we can ask FDA for permission to begin studies in humans. We want to do these as quickly as possible. And we won't get distracted. We believe many companies fail due to their inability to stay focused on the critical items that provide value for patients and shareholders. At Cellceutix we have the ability and the commitment to stay focused on those critical items.
Cellceutix is a publicly traded company trading under the stock symbol CTIX.OB on the bulletin board listings. Cellceutix is located outside of Boston, Massachusetts. The company's initial focus is the development and commercialization of its leading cancer compound, Kevetrin, as well as other compounds for cancer and inflammatory disease. The senior management of Cellceutix is composed of people with long experience in researching, developing and marketing innovative pharmaceutical products.
In my last letter I talked about changing directions. It's not unexpected in our business and is often a natural result of learning more about our products--that's what gets us up in the morning. Our recent progress has been a bit more linear, though, and we've found with Kevetrin(TM) that the more we learn, the more interesting it gets.
Over the past few months, we've done both in vitro and in vivo studies as we prepare for our IND filing with the U.S. FDA. With each study we've become more encouraged about the prospects for Kevetrin. We've found that the first results in drug resistant lung cancer cell lines weren't a fluke--in fact we've found consistently good activity in drug resistant breast cancer cell lines, as well. And we've started to learn that Kevetrin is pretty selective in the way it impacts anti-tumor pathways. It's not primarily a cytotoxic compound, with all the baggage that can bring.
-
In Vitro Studies of Kevetrin
Let's start with the in vitro studies. For quite some time, we've seen that Kevetrin works in reducing tumor growth in animal models. But we didn't quite know why. We had some early cytotoxicity studies that showed modest cytotoxicity in some cell lines, but not nearly enough to account for the anti-tumor activity we'd seen. In all these experiments, Kevetrin was significantly less cytotoxic than other chemotherapy agents, such as paclitaxel, cisplatin and 5FU. We decided that we had to know more about why Kevetrin was working. Since we believed that Kevetrin acted as an AKT inhibitor, we started with in vitro studies looking at various kinases. Kinases are molecules that play a role in many aspects of cell function. The activity of AKT, a protein kinase, is increased in many tumors thereby increasing the survival of cancer cells that would otherwise die. Thus, reducing AKT could be a good strategy for attacking tumors. Indeed, there are several AKT inhibitors on the market and under development.
We found that Kevetrin was in fact affecting kinases but not all in the same way. Kevetrin had potent anti-tumor activity even though it only partially inhibited AKT in one of the cell lines we tested. This was pretty surprising, so we decided to start exploring other components of the anti-tumor cell signaling pathway. We also found that Kevetrin was a potent inhibitor of p38 MAP kinase, another protein kinase important for tumor cell survival. We'll continue to look at other potential targets.
So what were our conclusions from this work? First it seems clear that Kevetrin is not acting primarily as a cytotoxic agent. This can be seen in all the cell lines and in the comparisons with paclitaxel, cisplatin and 5FU. Second, Kevetrin is very selectively affecting kinases. While we still need to learn more, this selectivity may account for the anti-tumor activity in drug resistant cell lines. We'll talk more about this later.
-
In Vivo Studies of Kevetrin
In the past few months, we've done experiments with Kevetrin against several drug resistant tumor cell lines. As I mentioned in the last letter, two experiments with the NCI-H1975 lung cancer cell line showed that Kevetrin had good anti-tumor activity--better than that of paclitaxel. Two experiments with the A549 lung cancer cell line again showed better anti-tumor activity than paclitaxel. In the meantime we did two experiments with the MDA-MB-435s breast cancer cell line and showed Kevetrin to be very active, while paclitaxel and cisplatin were not. These experiments were very consistent with an older experiment we had done in the HCT-15 colon cancer cell line.
In short, Kevetrin has shown excellent and consistent activity against a range of drug resistant cancer cell lines. These cell lines are quite difficult to treat, providing a terrific rationale for developing Kevetrin. Right now, it appears that the most promising avenue for development is to treat multi-drug resistant lung cancer.
We've also done some preliminary pharmacokinetic studies of Kevetrin in mice. As with the in vitro studies, the PK studies indicate that something very interesting is going on. The half-life of Kevetrin is about 2.2 hours. That means it is essentially cleared from the body within about 24 hours. But the activity is continuing for a substantially longer period. We need to do more work to understand this better but we think it suggests that Kevetrin is working in a very interesting way.
-
What does all this this mean?
Biotech companies have a tendency to talk excitedly about a lot of very complicated science. The excitement is, of course, genuine as the companies see great promise in what they are doing. But how do we understand what it all means? Just like a lot of other companies, we are doing a lot of very complicated experiments and coming up with a lot of dense data and great graphs. And we really like what we see. I think in our case, however, it is easy to explain what it all means. First, it means that we've accomplished a lot in a short time. And second it means that our lead compound, Kevetrin, is showing great promise in treating tumors that are otherwise very difficult to treat. This means hope for patients and value for shareholders.
George W. Evans, JD, MBA
Chief Executive Officer
Cellceutix was formed in May of 2007 by George Evans and Dr. Krishna Menon. The organization will develop the innovations of Dr. Menon and his team in the laboratory. The company owns intellectual property stemming from the inventions of Dr. Krishna Menon, whose background consists of over 35 years of experience working as team leader in drug development for top pharmaceutical companies and academic institutions. The Company also owns intellectual property developed by several prominent scientists and researchers.
Cellceutix is open to new partnerships that compliment its business strategy, technology and mission. In a growing industry with quickly advancing technologies for such things as drug delivery, biomarkers, etc., partnerships can advance the development process and at the same time provide business opportunities for a variety of partners. If your company is interested in finding out more about partnership opportunities please contact us at
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it and someone in our business development department will get back to you promptly.
Home 
Sitemap
Contact Us
