Farrell - Reg K, very interesting old article/interview of Dr M. just fyi-
" I even asked Dr. Menon if he was this excited with Gemzar and Alimta and he assured me that he was not and that Kevetrin™ could be much, much
bigger (he had to reiterate “could” as a matter of course of conduct). From a different perspective, each conversation with the Cellceutix staff was a real pleasure because of the honest-to-goodness excitement in the air.
They never seem to leave the lab. They’re there 12 to 14 hours a day, 7
days a week grinding away at more at more tests almost just so they can
say “Yup, Kevetrin™ worked on that too!”
What cancer will be tested next has not been released by Cellceutix, nor
would they speak to me about it for disclosure reasons, but there was
some “dancing around the bush” that it could be huge news if the ongoing
research is successful. I wish that I could offer more information as they have already hit the “big dogs” of cancers: breast, lung, colon and
leukemia. Pancreatic cancer, if not caught early, is a death sentence, so perhaps that is on the agenda, but that is purely a speculative guess on my part. Clinical Trials for Kevetrin™ Cellceutix is nearing the targeted date of filing their Investigational New Drug (IND) application with the U.S. Food and Drug Administration and reported that it should be submitted in May 2011. Barring any complications, Kevetrin™ should be in humans as a cancer treatment sometime around August 2011. Confidentiality has kept the hospital location from being released, but it has been stated that the trials will be held at one of the world’s most prominent cancer centers.
Put your thinking cap on and pay attention as here is the most important
thing to understand about Phase I clinical trials for Cellceutix. Typically, Phase I trials address safety for a new drug. For obvious reasons, the FDA,the hospital and the biotech firm have to make sure that giving their new drug to a human isn’t going to kill them and they have to evaluate tolerable dosage levels.
This process will not be true in the same manner for Cellceutix. Their
patients will consist of the worst of the worst cancer patients; patients that have late stage or terminal cancer. This is EXACTLY what a Company like Cellceutix wants to see. Remember, they are targeting extreme, drugresistant cancers with Kevetrin™.
There will obviously be an evaluation of safety component to the trials, but efficacy, although not the intent of the study, will be noted. If Kevetrin™ demonstrates efficacy on any level, it’s not a window of opportunity opening for Cellceutix, it’s a set of barn doors flying open as they will have a drug that can be of benefit to a terminal patient. It will need to be moved as quickly as possible to be tested as a front-line defense.
While most people believe that the FDA review process is extremely slow
and that it takes nine to eleven years to bring a drug to market, this is not true on every occasion. The FDA has programs in place to expedite new drugs to advanced clinical stages that meet an area of great unmet medical need. The “Accelerated Approval” and “Priority Review” programs are exactly what Cellceutix will be focused upon should efficacy should be demonstrated which could literally mean a jump straight to Phase III
clinical trials after a very minimal time in Phase I. Per standard protocol,when Phase III is completed, a New Drug Application (NDA) is filed, which also can be moved through at an expeditious pace. Abbot Laboratories, Inc. is a prime example as their HIV infection drug, Norvir, received NDA approved in 72 days from the date of submittal.
Why is Kevetrin™ a strong candidate for this sort of fast-tracking? Because Kevetrin™ is like nothing else. It is, in fact, classified as a completely new chemical entity in medicine. Read that again. It’s a “completely new chemical entity in medicine.” That’s how unique it is. It also is being developed to treat diseases that kill over 100,000 people annually. If Kevetrin™ proves safe in humans and eliminates cancer as is has in animal studies, it should move rapidly through the FDA approval process. What normally would take years and years of clinical trials could be slashed to as little as 24 or 30 months for Kevetrin"
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