Cellceutix Corp (OTC:CTIX) has completed the first cohort in a clinical trial of Kevetrin, a revolutionary drug in the treatment of cancer. The second cohort is starting shortly. The trials are being conducted by Harvard University's Dana Farber Cancer Institute and partner Beth Israel Deaconess Medical Center. The commonly associated toxic side effects in cancer therapies didn't show up.
CTIX is based in Beverly, Massachusetts and is a clinical stage biotech company. Kevetrin and Prurisol are two of their drugs that should be watched closely for potential events in 2013. The product pipeline includes eight drugs.
The Kevetrin trial at Dana Farber is still recruiting subjects for future cohorts per the FDA clinical trials site.
As you review the FDA protocol you can actually use this information as a roadmap or calendar of sorts to upcoming PRs from CTIX. Future data points show where CTIX may have enough information for another PR on this trial.
Additional studies are being conducted at Beth Israel Deaconess to research Kevetrin in conjunction with two Pfizer, Inc. (PFE) multikinase inhibitors as potential new therapies for renal cancer and melanoma. In 2013, we expect to start a clinical trial against blood tumors, sponsored by a European university.
Their psoriasis drug, Prurisol has planned Phase 2/3 trials set for early 2013. Dr Reddy's Laboratories Limited (NYSE: RDY) is manufacturing the drug for this upcoming trial. The double blind study will be 30 days of patient dosing and 30 days of follow up visits.
There has to be a fundamental reason for investing in stocks under $5, especially in the biotech arena since the charts don't always help. Charts can't give you any clues about pending FDA approvals. With changing technology and upcoming regulation changes you may miss the early boat if you are waiting on PDUFA dates. Many investors have become accustomed to waiting for later stage trials to get involved in biotech stocks. That is changing as the regulatory landscape changes with the adoption of new breakthrough therapies standards by the FDA. S.2236 Advancing Breakthrough Therapies for Patients Act of 2012 may become law this summer. With a ground breaking new cancer drug in Kevetrin, CTIX may end up using this route.
Kevetrin has demonstrated in animals the ability to activate p53 without the major toxic effects Roche Holding (RHHBY.OB) ran into when they tried it. We will find out very soon whether or not Kevetrin activates p53 in humans. The fact that the first cohort completed in human trials without exhibiting the commonly associated toxic side effects that come with chemotherapy is a huge event.
Another thing interesting about the Kevetrin trial at Dana Farber is the fact that a secondary objective is being sought in addition to the first safety objective. They are also testing for efficacy.
Being an OTC stock under $5 without full trial data on humans completed, there is risk. However, there is also the potential for greater reward. We'll see where the stock price is at in 12 months.