Cellceutix Reports on Kevetrin Clinical Trials and Prurisol Manufacturing
Published: Feb 25, 2013
BEVERLY, MA--(Marketwire - 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.
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53 (often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome") and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.
Further information on the clinical trial, titled "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors," is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
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