BEVERLY, MA – December 3, 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 clinical trials for Kevetrin™, the Company’s flagship anti-cancer drug, are progressing smoothly. In the clinical trials, being conducted at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, the cohort which began treatment with Kevetrin early in November has completed the initial cycle.
To date, the group of subjects has been reported to be within normal parameters of the clinical protocol. A total of 84 blood samples from the patients have just been sent to the laboratory for pharmacokinetics analysis.
As per the clinical protocol, the Safety Committee will now meet to approve continuation of dose administration for the benefit of that group of patients and to approve increasing the dose for the next group of patients, which the Company expects to begin in mid-December.
“The clinical trials are progressing extremely well and right on schedule,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “As we await the lab reports, it’s very encouraging that we have not seen any of the toxic side effects that are commonly associated with chemotherapy at this point. Many new drugs demonstrate toxicity immediately, so I interpret the information on Kevetrin™ with a great deal of optimism. We are excited for the upcoming weeks when the next cohort, in which dosing levels will be doubled, may provide us even greater insight on what we believe is the most exciting oncologic drug in development today.”
Regarding Prurisol™, the Company’s drug in development as a new therapy for psoriasis, Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) has advised the Company that scale-up manufacturing is underway. During the pilot developmental studies, Dr. Reddy’s was able to improve the yield and purity and reduced the synthetic steps required. This will save Cellceutix valuable time and money in the manufacturing of Prurisol for the planned Phase 2 / 3 clinical trials.”
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