Cellceutix to Submit Special Protocol Assessment Request to FDA for Phase 3 Clinical Study of Antibiotic Brilacidin for ABSSSI

BEVERLY, MA–(Marketwired – February 9, 2016) 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 it will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria.   The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.

In July 2015, Cellceutix reported the outcome of a successful End-of-Phase 2 Meeting with the FDA, during which the agency provided input on the Company’s proposed phase 3 program.  This meeting was a significant milestone for Cellceutix and it triggered the start of phase 3 activities.  An agreement was reached in conducting two randomized, well-controlled phase 3 non-inferiority studies, comparing Brilacidin to an approved ABSSSI regimen, with an interim analysis as part of the first study.  In addition, and in part related to the novelty of Brilacidin as a completely new class of antibiotic, the FDA requested additional information before the start of the first phase 3 study.  Cellceutix is pleased to announce that it has completed this research, compiled the requested information and is submitting it, along with the final protocol for the clinical studies, in the request for a SPA.

A Special Protocol Assessment is a written agreement between the FDA and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market.  In the SPA request, Cellceutix is including its choice of comparator for the phase 3 program, consisting of intravenous vancomycin with an option to switch to oral linezolid after three days of therapy.  This is considered conventional therapy for ABSSSI and is the same comparator used in the phase 3 program for a recently approved ABSSSI drug.

“Submission of the SPA request is an important milestone in initiating the phase 3 studies of Brilacidin.  Using this process helps to ensure harmony with the FDA on trial design and endpoints for this first-in-class antibiotic that we believe has the opportunity to deliver a meaningful impact to ABSSSI patients with a reduced likelihood of resistance developing compared to competitors,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix.  “We want to enter this market as we believe with the right partner or distributor, a successful trial resulting in an FDA approved Brilacidin for ABSSSI, it could be a market leader and potentially generate hundreds of millions of dollars annually.”