Beverly, MA — 06/03/13 — 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, announces that it has published its poster on Kevetrin, the Company’s p53 modulating drug, being presented at 8:00 AM ET today at the 2013 American Society of Clinical Oncology (“ASCO”) Annual Meeting being held in Chicago, Illinois from May 31 through June 4, 2013.
The poster summarizes information from the ongoing Phase I trial being conducted at Harvard Cancer Centers, including Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center and Massachusetts General Hospital. Research is characterizing the pharmacokinetic profile of Kevetrin, along with evaluating preliminary evidence of anti-tumor activity and potential biomarkers of tumor response to Kevetrin by activation of p21.
The presentation is available for viewing at: http://cellceutix.com/events/
Cellceutix wishes to commend the efforts of Dr. Geoffrey Shapiro, Dr. Jeff Supko, Dr. Daniel Cho and their teams in the clinical trial and poster presentation. The Company considers itself fortunate to be working with such world-renown leaders in oncology trials and research.
“The trial, which is currently in the fourth cohort, is progressing with data to date on par with our laboratory studies,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Through three completed cohorts, we have seen no signs of dose limiting toxicity. Dana-Farber’s extensive tumor mapping technologies will help us pinpoint which patients will benefit the most from Kevetrin as we move towards defining the Maximum Tolerated Dose. We are very pleased with the results so far and believe that as dose escalation continues, the potential therapeutic benefits will rise significantly.
Dr. Menon continued, “Some very exciting times are approaching as we expect to reach Maximum Tolerated Dose between the sixth and ninth cohorts. We also look forward to data on the p21 biomarker, which was not available for the ASCO meeting as the laboratory moves the samples into queue, in the coming weeks. As can clearly be seen in the poster, at this time ten patients have been treated with Kevetrin at low doses. Five patients have received more than one cycle of Kevetrin, including one patient who has already completed seven dosing cycles. This lends to our enthusiasm about the potential of Kevetrin and our sanguine outlook for the second half of the year.”
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