BEVERLY, MA – October 8, 2012– 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, reports today that it has been advised that the clinical trials for the Company’s novel anti-cancer drug candidate, Kevetrin™, will be going active this week at Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.
Upon the new designation, the trial information on http://www.clinicaltrials.gov/ will be updated to “recruiting” status. 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
The Company has been informed that Dana-Farber and Beth Israel Deaconess are ready to begin the recruiting, enrollment and dosing processes as previously reported. Cellceutix has been advised to expect the first dosing of Kevetrin to be administered within approximately one week of activating the trial.
In a separate matter, the Company wishes to update shareholders that Dr. Reddy’s Laboratories has already started on the project of manufacturing Prurisol, Cellceutix’s new drug candidate for the treatment of psoriasis. As previously disclosed, the Company is advancing Prurisol directly into Phase II clinical trials under guidance from the U.S. Food and Drug Administration. The clinical trials are planned to commence upon the manufacturing of the drug candidate in oral form by Dr. Reddy’s Laboratories.
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.