Cellceutix Provides Brilacidin Update; New Class of Antibiotics to Enter Phase 3

BEVERLY, MA--(Marketwired - October 30, 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 provide an update on brilacidin, a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics or defensin-mimetics. Last year, the Company successfully completed a phase 2b study in patients with Acute Bacterial Skin and Skin Structure Infections (ABBBSI). There were there were no serious adverse events (SAEs) that were deemed by the principal investigator (PI) as related to study drug. Efficacy was high across all brilacidin treatment groups, including the two single-dose groups, and similar to daptomycin, the active comparator. "To show similarity to a gold standard such as daptomycin is impressive -- especially when our drug is given one time, while daptomycin is given every day for seven days," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "I am very happy that we acquired brilacidin and the other HDP mimics. We acquired the HDP mimics for a song, a move that, considering all that we've already accomplished, I anticipate to turn out as a phenomenal business decision for Cellceutix shareholders."

Brilacidin received Qualified Infectious Disease Product (QIDP) designation under the GAIN Act in November 2014, and the Company had a positive End-of-Phase 2 Meeting with FDA in July 2015.

Although phase 3 start up activities may take a little longer than usual for a new class of compounds, the Company remains on track in its preparations.

"We are producing large quantities of brilacidin that can be used in the phase 3 program, and in the coming weeks, we will be completing our laboratory testing on the newly manufactured compound," said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Our goal is to maximize the purity of the compound for phase 3 studies. We have accomplished this in making the active pharmaceutical ingredient (API) so that the final product is greater than 99% pure, with a very high yield. In lab tests so far, the new compound has passed all our rigorous quality control tests and we are very pleased with what we see."