Brilacidin Phase 2b Trial 60 Percent Enrolled, Seventh Cohort Complete in Cancer Drug Trial
BEVERLY, MA–(Marketwired – Jun 2, 2014) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, reports today that patient enrollment has been completed in the Company’s Phase 1 crossover study of its anti-psoriasis drug candidate Prurisol. Cellceutix expects lab results, pharmacokinetic studies, and analysis to take approximately two months. If the data shows bioequivalence of Prurisol with Abacavir Sulfate, the Company will then schedule a meeting with the U.S. Food and Drug Administration regarding initiating a Phase 2/3 trial of Prurisol through the 505(b)(2) regulatory pathway.
Cellceutix would also like to update shareholders on other ongoing clinical trials and laboratory research. The seventh cohort has been completed in the Phase 1 trial of the Company’s anti-cancer drug candidate Kevetrin being conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet next week to determine the dosing amount for the eighth cohort. Cellceutix anticipates that dosing will be increased by about 33 percent, or approximately 215 mg/m2, but there are no assurances as any dosing increases are at the sole discretion of the safety committee. As of today, the Maximum Tolerated Dose (MTD) of Kevetrin has not yet been reached.
The Phase 2b trial of Cellceutix’s antibiotic Brilacidin is progressing as planned with approximately 60 percent of patient enrollment completed. As of today, no drug-related serious adverse events have been reported in the trial.
Separately, Cellceutix last week entered into a research agreement with a renowned non-profit research institution for studies of anti-fungal compounds in Cellceutix’s portfolio. The research is to be funded by a $1.5 million grant from the National Institute of Health, Small Business Innovation Research (SBIR) to the non-profit institution. A Notice of Grant Award Letter has been issued, but funding has not yet commenced.
“We are very proud of how much we have grown in the past eight months at Cellceutix and how many wheels are in motion studying our extensive portfolio from early stages to nearing completion of a Phase 2b trial,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. ”In addition to the aforementioned clinical trials, we have antibiotic and antifungal compounds being studied at various leading universities across the country; Brilacidin studies for diabetic foot ulcers ongoing; the Investigational New Drug application being completed for a Phase 2 trial of Brilacidin for oral mucositis; formulation work being conducted on Brilacidin for ophthalmic and otitis therapies; and other research happening for new drugs. While that’s a mouthful, it still only covers a portion of the day-to-day developments at our Company as we relentlessly strive to meet our goals of providing therapies for great unmet medical need and delivering strong shareholder value.”