BEVERLY, MA – February 25, 2013– Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to provide shareholders an update on Kevetrin™, the Company’s novel drug in development for multi-drug resistant cancers, and Prurisol™, the Company’s anti-psoriasis drug in development set to commence mid-stage clinical trials.
The Phase 1 clinical trial of Kevetrin targeting solid tumors at Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center is progressing as expected with the next cohort to begin treatment at escalated dosing levels. Studies evaluating the p21 biomarker will soon begin and the first data report is expected in mid-March.
“We are excited by the advancement of the clinical trials of Kevetrin as we move toward finding the MTD (maximum tolerated dose),” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “While we are still early in the trials, we are eager to receive information on the p21 biomarker as it could represent a major breakthrough in cancer research. There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
Regarding Prurisol, Dr. Menon and Cellceutix Chief Executive Officer Leo Ehrlich have recently returned from meetings with Dr. Reddy’s Laboratories Ltd., (Dr. Reddy’s”), a New York Stock Exchange listed company, at Dr. Reddy’s state-of-the-art manufacturing facility and headquarters in Hyderabad, India.
Dr. Reddy’s has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013.
“At our meetings with Dr. Reddy’s, we met with over twenty scientists working on the Prurisol project. I was very impressed with the comprehensive scientific team that they have dedicated to our project,” said Leo Ehrlich. “While they had already informed us that they had reduced the number of manufacturing steps, Dr. Reddy’s has now advised that they have further condensed the process, which is delivering much higher yields than originally anticipated that ultimately will save us valuable time and money in the production of Prurisol.”
The Company is pleased to report that the recently filed registration statement with the Security and Exchange Commission is now effective, thus concluding the imposed “quiet period”.
Additional updates on the planned studies testing Kevetrin against Acute Myelogenous Leukemia at the University of Bologna as well as other corporate developments relating to research on Kevetrin at a world-renowned cancer center in the Southwest United States are forthcoming shortly.
"Studies evaluating the p21 biomarker will soon begin and the first data report is expected in mid-March."
Even so the statement notes about additional updates forthcoming the next true catalyst will the data points coming up in mid march. I would think that any positive news in that regards could be pushing the stock over three Dollars.
I agree with you. Given previous tox tests, I'm not as concerned about toxicity as I am efficacy and p21 is all about the latter. The p21 marker will mean p53 is working. And if it showing signs of working prior to the MTD being determined, we will be off to the races!
Sentiment: Strong Buy
IMO the best part of this PR is:
"There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
If Kevetrin shows efficacy in Phase I, there is no doubt the FDA will designate it as a breakthrough therapy. If that's the case, CTIX only needs to do an expanded Phase I before FDA can approve the drug. So it's possible that Kevetrin can be in the market in late 2014 / early 2015.
This is everything I would have expected even without news. I wish he would have said sometime in second quarter instead of mid march for the p21 biomarker thing. Then if we get the news early people would be surprised in a good way. Now when mid march comes and goes without the news people will panic.