BEVERLY, MA–(Marketwire – May 21, 2012) – Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company developing a novel drug to treat cancers and cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers), is pleased to announce that its amended Investigational New Drug (“IND”) application for Kevetrin™ has been submitted to the U.S. Food and Drug Administration (“FDA”) today. As previously disclosed, the planned Phase 1 clinical trial for this pioneering drug is to take place at the Harvard Cancer Center in Boston.
Per standard protocol, the FDA now has 30 calendar days to review and present any questions related to the IND before the Company can initiate the commencement of the clinical trial. The clinical trial will test Kevetrin against a variety of cancer types in patients with advanced-stage cancers. Primary endpoints for the study will be safety and tolerable dosing levels for a future Phase 2 clinical trial.
Cellceutix consultant Dr. Sylvia Holden commented, “I have been researching new drugs for nearly 30 years. Cellceutix is now a true pioneer in oncology discovery with this very special compound, Kevetrin. The Mechanism of Action of Kevetrin™, impacting both wild and mutant types of p53 to induce apoptosis and cell cycle arrest through multiple pathways while being well-tolerated, is what sets it apart from other chemotherapies today. Rather than being a traditional drug that targets and attempts to seek and destroy cancer cells independently, Kevetrin™ revitalizes p53 so that the body’s natural defense system eliminates the tumor on its own. As a stand-alone or combination front-line therapy, the magnitude of the potential of Kevetrin™ is simply unparalleled by anything that I have ever seen in the laboratory before.”
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix commented, “I will be attending the American Society of Clinical Oncology (“ASCO”) Meeting in June to continue discussions regarding Kevetrin™. We anticipate that next year we will be presenting data from this year’s planned clinical trials.”
About Dr. Sylvia Holden: Dr. Holden received her PhD from Boston University followed by an NIH-funded post-doctoral fellowship at Dana-Farber Cancer Institute in the Division of Cancer Pharmacology headed by chemotherapy pioneer and Cellceutix Scientific Advisor Dr. Emil Frei III. Before joining Cellceutix, Dr. Holden was the Director of Pharmacology at EMD Serono in Billerica, MA (Merck KGaA) and Director of Tumor Biology at Shionogi BioResearch Corp., in Lexington, MA (presently Synta Pharmaceuticals). She was awarded 5 US patents and has published over 100 publications in peer-reviewed journals, including 12 first-authored papers and publications in Science and Nature Medicine.