BEVERLY, MA–(Marketwired – Mar 19, 2014)- Cellceutix Corporation (OTCQB:CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the seventh cohort is now in progress in the Company’s ongoing Phase 1 clinical trial of Kevetrin™, Cellceutix’s novel anti-cancer drug candidate.
The seventh cohort dosing is 165 mg/m2 of Kevetrin™, compared to 110 mg/m2 in the prior cohort. Cellceutix is pleased to report that Maximum Tolerated Dose (MTD) has yet to be reached through the completion of six cohorts.
As announced on January 15, the U.S. Food and Drug Administration approved an amendment to the trial protocol to limit the maximum infusion timeframe to six hours throughout the remainder of the trial. The implementation of the amendment at the two hospitals took approximately two months.
“We are excited that the seventh cohort is underway as we feel that we are drawing closer to achieving MTD, which represents a milestone for our Company,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix. “The internal procedures at the clinical sites have moved a little more slowly than we hoped, but that is beyond our control and not out of the ordinary when working with some of the world’s leading cancer research centers. Kevetrin is in great hands and we are glad to be moving towards completion of this study. On another note, we have been updated that enrollment in our Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is progressing smoothly across multiple sites. We are very pleased with the clinical development of both of these novel compounds.”
The clinical trial of Kevetrin is an open-label, dose-escalation study being conducted at Harvard University’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center to assess the safety and tolerability of Kevetrin™, a small molecule compound shown in the laboratory to activate the key tumor suppressor protein p53, in patients with advanced solid tumors.