Cellceutix Corporation (OTCQB:CTIX) disclosed that it has signed a laboratory agreement with Dana-Farber Cancer Institute, Harvard University’s cancer hospital, for its planned Phase I clinical trial for Kevetrin™, Cellceutix’s novel cancer compound for the treatment of drug-resistant cancers. While entering clinical trials is a milestone event for any biotechnology firm, having the trial at the world’s number one cancer research center speaks volumes for the potential of Cellceutix and Kevetrin™. DF/HCC, is afforded the ability to be extremely selective as to which drugs in development it will devote its resources and they do not seem to pick a small drug maker very often. Of course, there are a whole host of big pharma that have conducted, or are conducting, clinical trials at DF/HCC including the likes of Pfizer, Inc. (NYSE:PFE), Astrazeneca PLC (NYSE:AZN) and Eli Lilly & Co. (NYSE:LLY), but small caps are few and far between. Although they may exist, no Over the Counter or OTCQB-listed companies were found, further showcasing the extreme rarity of Dana-Farber/Harvard Cancer Center agreeing to host a clinical trial of a small, pre-clinical company.
While a trial at DF/HCC, by no means implies impending achievements or drug approval by the Food and Drug Administration, some major drugs have come through the cancer center and have led to great successes for companies. Millenium Pharmaceuticals researched bortezomib (Velcade®) at Dana-Farber as an indication for multiple myeloma. Velcade® received FDA clearance in only seven years after initial synthesis even with early-stage trials moving notably slow as the drug moved through three different companies at first. Millenium was bought by Takeda Pharmaceutical Company (TSE:4502) in April 2008 for nearly $9 billion with Velcade® as its flagship product which is still undergoing research at Dana-Farber for different indications.
It is an arduous endeavor to seek approval for clinical trials at the world’s elite cancer center as each and every component of the initial review process can be painstakingly slow as a result of required procedural assessments. One can only imagine the number of committees that review the application. Unlike other hospitals which may provide a more expeditious service, the recognition and expertise that accompanies an outfit like Dana-Farber/Harvard Cancer Center showing a desire to research a particular drug is well worth the patience.
Having clinical trials hosted at DF/HCC should place Cellceutix at the forefront of developmental biotechs of all sizes, regardless of exchange listing; especially those in Phase I and a good portion of those in Phase II at lesser-known cancer centers. While no hospital ensures a positive outcome to clinicals, it could be discerned that odds are increased due to the selective nature of compounds that are permitted to enter trials at DF/HCC. Moreover, due to Kevetrin™ targeting drug-resistant cancers, Cellceutix will be researching their drug on terminal cancer patients (their ideal candidate) which raises the bar during Phase I as not only will the primary endpoint of safety be evaluated, but the possibility of efficacy being shown is a reality of the trials. Any sign of efficacy for a completely novel compound significantly increases the odds of expeditious development designations from the FDA.
Novel drugs are a hot commodity for any indication at the moment. Pharmasset, Inc. (NASDAQ:VRUS) is developing PSI-7977 as a treatment for Hepatitis C and posting strong results. The data has helped drive shares of VRUS northward by more than 250 percent so far this year to the $80 range (which would actually be $160 per share except for a 2 for 1 forward split in August). Split-adjusted shares were as low as $3.81 for VRUS just 2-1/2 years ago. Only in Phase II with its drug, Pharmasset boasts a nearly $6 billion market cap and serves as a solid reminder to followers of Cellceutix (with its current $32 million market cap and $0.37 per share price tag) as to what can happen in the mid-term with a potent drug candidate.
Cellceutix and Kevetrin™ have apparently impressed Dana-Farber/Harvard Cancer Center and its associates. Moreover, Cellceutix has Dr. Krishna Menon at the research helm as Chief Scientific Officer. Dr. Menon knows a bit about developing successful drugs from his time as a lead researcher at Eli Lilly where he won a President’s Award for his work in the development of multi-billion dollar cancer drugs Gemzar and Alimta. In June of this year, commenting on the robust pre-clinical research the has been generated studying Kevetrin™ on many different strains of cancer including breast, colon, lung, pancreatic and leukemia, Dr. Menon stated in a Cellceutix press release, “In all my years as a researcher, I have never seen anything like Kevetrin™.” That’s a strong statement and certainly food for thought about where Cellceutix could be in the near future.
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