Kevetrin is First-in-Class of Novel Chemistry to Reach Clinical Stage
BEVERLY, MA – November 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, is pleased to report that dosing of patients is now being conducted in clinical trials with Kevetrin(TM), the Company’s novel anti-cancer drug candidate, at Harvard University’s Dana Farber Cancer Center and Beth Israel Deaconess Medical Center.
This major milestone transitions Cellceutix into a clinical stage biotech company with a novel drug in some of the leading cancer hospitals in the world. Kevetrin has reached its initial clinical stage goal of Phase 1 human trials for solid tumors and the protocol is now being written for clinical trials in blood cancers at university-sponsored studies in Europe.
“These advancements for a small biotech company could not have been possible without the dedication and passion our whole team demonstrated working on Kevetrin,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Kevetrin has shown in laboratory studies to activate p53, ‘the Guardian Angel Gene,’ to reduce tumor volume and slow tumor progression in cancers which other drugs were ineffective in doing so. A completely new class in chemistry, we believe that our novel drug is something that the cancer industry has been in search of for decades. We have extremely high expectations for Kevetrin.”
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.
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