Cellceutix Corporation (OTCQB:CTIX) is a development stage biopharmaceutical company, engages in the discovery and development of small molecule drugs to treat unmet medical conditions. In my last article, I was really surprised when I found the studies to combat cancer that this company was carrying out. For example, Prurisol, a small molecule compound for the treatment of Psoriasis (Prurisol-KM133), that passed its studies from animals to humans with such a promising studies that the U.S. Food and Drug Administration ("FDA") allowed it to go directly to phase II.
I contacted Cellceutix CEO, Leo Ehrlich, before taking the decision to invest in this company as well as to help us gain a better understanding of the company's plans and future prospects and I have had the honor of interviewing him.
Here is the entire interview:
[JA] Cellceutix has a team formed by Dr. Emil Frei III, Dr. Paul Marks, Dr. Samuel Danishefsky, Dr. Paul Ginsburg, Jim Boeheim, Dr. Krishna Menon and Leo Ehrlich. They are all well known in the medicine and oncology fields. Could you please tell me more about the start of the company?
[CEO] When I was 13 years old, I lost my father to cancer. In 2006 my mom was diagnosed with Stage 4 colon cancer. The family was advised that the chemo treatments would be difficult and painful to her and at best her life expectancy will be quite short. I then became familiar with the various chemotherapies and saw firsthand the toxic effects of these drugs. It was during this time that I turned to an acquaintance of mine, Dr. Menon, for advice. He explained he was working on an anti-cancer compound with little toxicity to fight cancer. I was intrigued and we formed Cellceutix to try and find some better solutions. The novel characteristics of our drug pipeline intrigued these highly accomplished individuals and they agreed to join our team.
[JA] Cellceutix recently announced that Kevetrin's Phase I clinical trials will be studied in Harvard Cancer Center's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. How many patients will be enrolled?
[CEO] The IND approved by the FDA allows up to 40 patients to find the maximum tolerated dose.
[JA] What is the most important reason to trust in Kevetrin?
[CEO] In one word "p53". A lot of information is available on the internet and our website about "p53, the guardian angel gene". Simply, if it works it could be a major breakthrough in treating cancer. Also, look for people who have already achieved great success as statistically they are more likely to create another great success. Our President and Chief Scientific Officer, Dr. Menon, has more than 30 years in drug development for academia and industry. Dr. Menon was a Research Associate Scientist at Dana-Farber Cancer Institute. He was also Group Leader of Cancer In Vivo Research and Clinical Development for Eli Lilly (LLY), where he played a key role in lead selection and pre-clinical development of Lilly's blockbuster cancer drugs Gemzar and Alimta, which generate billions of dollars in yearly sales. In 1999, Lilly honored Dr. Menon with the President's Recognition Award, the highest award at the company.
[JA] What was the main circumstance that led you to pass from using Kevetrin in animals to use it in humans?
[CEO] This was a very thorough project that took quite some time. The results in the animal studies were so strong that they initially surprised us. Kevetrin showed remarkable abilities in slowing tumor growth and reducing the size of tumors in every cancer line that we tested it. Many biotechnology companies find their drug candidate pigeon-holed to one particular indication, but we have found it to produce robust results in both solid tumors and blood tumors. We knew we had to move this to clinical trials as quickly as possible.
[JA] If Kevetrin's Phase I results were in line with laboratory data, would you request FDA to pass directly to Phase III?
[CEO] Obviously, YES!
[JA] I would like to congratulate you on the recent FDA approval to initiate a Phase II clinical trial on Prurisol, your psoriasis drug. What size do you estimate that market potential would be for a new psoriasis drug?
[CEO] It is a little early to forecast the market potential for Prurisol. However, should Prurisol perform in clinical trials as it did in the lab, I would think the potential for a drug that works so well would exceed $500 million annually and possibly even one billion dollars.
[JA] There are rumors on the market about the company's incorporation to Amex or NASDAQ markets. Are you considering the possibility to do so?
[CEO] We will look into NASDAQ when the time is right. It is our top priority to advance the many clinical trials on Kevetrin and Prurisol both here and abroad as quickly as possible.
[JA] In a recent article I wrote about Cellceutix, I checked that the company only has 96k on cash.
Are you thinking about going into a partnership with another pharmaceutical company? Are you going to look for external funds?
[CEO] We always have low cash balances. We presently have a financing line available to us. I believe we have the ability to raise additional funds as needed. We want to advance the clinical trials on our own and are very fortunate that other parties approached us to sponsor clinical trials on Kevetrin. The European trials on Kevetrin as well as a second clinical trial at Beth Israel Deaconess are being funded by other parties, which will provide us with unprecedented data at no cost to our company. While we have Non-Disclosure Agreements in place and are aware that some major pharmaceutical companies are watching us, it is, in my opinion, too early for us to consider partnerships.
[JA] In Cellceutix's portfolio there are three compounds which are really interesting: KM-391 a compound for autism; KM-227 for arthritis; and KM-278 for asthma. They are all in a pre-clinical situation. When do you think they will pass to Phase I for being dosed directly on humans?
[CEO] We have put these projects on hold as we devote our resources to the Kevetrin and Prurisol clinical trials. When our resources increase, we will turn our attention to those compounds.
[JA] How long do we have to wait before seeing some results from clinical trials?
[CEO] I expect in 2013 our shareholders will be deluged with clinical results from the various trials.