Cellceutix Provides Initial Observations of Completed ABSSSI Phase 2b Trial; Company Submits Investigational New Drug Application to FDA for Phase 2 Trial of Brilacidin-OM for Oral Mucositis

BEVERLY, MA--(Marketwired - Sep 9, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce this update on its recently completed Phase 2b study of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections ("ABSSSI").

The study was a 215-patient blinded trial with four treatment arms and approximately 50-55 patients per arm. Three of the arms evaluated Brilacidin, two single-dose arms and one 3-day regimen, and the fourth arm was daptomycin of once per day for seven days. Daptomycin for injection is marketed by Cubist Pharmaceuticals under the brand name Cubicin® and generated approximately $447 million in sales in the first half of 2014.

The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to -- if not higher than -- cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company's Phase 3 study design.

Cellceutix will not know the actual cure rates per treatment arm until the data is unblinded in October/November. However, the Company is very optimistic and views the high average cure rate on the blinded data as a very good sign for Brilacidin. Assuming positive results after unblinding, Cellceutix will have proven that Brilacidin is a safe and effective drug in the Phase 2 trial, and all activities will be triggered for initiation of a pivotal Phase 3 trial.

"We are very excited about the prospect of using a novel class of antibiotics to treat serious infections caused by Staph aureus, including MRSA, and potentially, with a single-dose," commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Because of the extremely unlikely chance of developing resistance, and the other benefits conferred by a short or single-dose therapy, such as near 100% compliance, we feel Brilacidin is a game-changer in the field of antibiotics for serious and resistant infections."