Company Reports Successful End-of-Phase 2 Meeting with FDA
BEVERLY, MA–(Marketwired – July 20, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has agreed to advancing brilacidin into phase 3 for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
During a recently held End-of-Phase 2 Meeting, Cellceutix and the FDA discussed safety and efficacy data that support advancement into phase 3, as well as the basic elements of a phase 3 program. The planned phase 3 program would include two phase 3 ABSSSI studies, as required by FDA Guidance. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting.
Dr. Daniel Jorgensen, Cellceutix’s Chief Medical Officer and leader of the team that met with the FDA, was pleased with the outcome of the meeting. “This was a collaborative meeting, and the FDA was extremely helpful in providing guidance on our clinical development program in ABSSSI. The plan for an interim analysis makes sense, as this is a brand new class of antibiotics.”
Brilacidin is the lead compound in a new class of antibiotics known as the defensin-mimetics. These compounds mimic the host defense proteins of the innate immune system, and therefore, have both antibacterial and immunomodulatory properties. Brilacidin has been administered intravenously in over 400 subjects in phase 1 and phase 2, and is currently being evaluated in a phase 2 study as a topical rinse for the prevention and treatment of oral mucositis in cancer patients.
Brilacidin was granted Qualified Infectious Disease Product (QIDP) designation by the FDA in November 2014. The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act for the purpose of encouraging development of new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that brilacidin is now eligible for additional FDA incentives, including Fast Track designation and Priority Review for clinical development, and a five-year extension of market exclusivity.