BEVERLY, MA—Dec 16, 2013 – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that it has submitted the application to the Institutional Review Board (“IRB”) responsible for the Company’s planned Phase 2b clinical trial of its novel antibiotic Brilacidin as a drug candidate for Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”).
The protocol for the clinical trial was constructed following the successful completion of a Phase 2a clinical trial of Brilacidin for ABSSSI. The Company anticipates that the trials will commence on schedule in just a few weeks, in January 2014. The clinical trial information will soon be updated on www.clinicaltrials.gov
Cellceutix is particularly excited about the timing of its recent acquisition of novel antibiotic and antifungal compounds because of the introduction last week of the ADAPT (Antibiotic Development to Advance Patient Treatment) Act of 2013 by the House of Representatives to expedite development of new antibiotics and antifungal drug candidates. The bill builds upon the GAIN (Generating Antibiotic Incentives Now) Act that was passed in 2012 to provide incentives, such as extended periods of exclusivity and smaller patient populations for clinical trials, for new antibiotics that target areas of great unmet medical need. The FDA is demonstrating its commitment to find solutions to the growing problem of bacteria infections. Cellceutix feels its drug candidates are prime candidates to benefit from these government initiatives.