SOURCE: Cellceutix

September 24, 2013 09:30 ET

Cellceutix Plans Phase 2b Trial of New Antibiotic, Reports Fifth Cohort Complete in Novel Cancer Drug Clinical Trial

BEVERLY, MA--(Marketwired - Sep 24, 2013) - Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to inform shareholders about progressions in the development of Brilacidin™, a novel small molecule antibiotic, and Kevetrin™, the Company's anti-cancer drug being evaluated for the treatment of solid tumors at Harvard University's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.

Cellceutix has met with the Contract Research Organization (CRO) that was responsible for the successful completion of the Phase 2a clinical trial of Brilacidin for acute bacterial skin and skin structure infections, or ABSSSI. With the newest information, Cellceutix will now request a meeting with the U.S. Food and Drug Administration to discuss protocol for a Phase 2b trial that is planned to be held at multiple centers worldwide.

"Just like everyone else that we've met with to discuss Brilacidin, the CRO was extremely impressed with the results from the clinical trial, as the drug was efficacious at a variety of dosing levels," said Leo Ehrlich, Chief Executive Officer of Cellceutix. "They provided us valuable insight in outlining the structure of a Phase 2b trial, which we are confident will be short in duration with the primary goal of defining optimum dosing levels for the Phase 3 trial. We will discuss with the FDA the clinical protocol and our intentions to file for a Fast Track designation. Further, we are investigating commercialization potential of Brilacidin internationally that we believe may be a possibility before even a Phase 3 trial is complete. Brilacidin was very effective and impressive to the clinicians in the completed Phase 2a trial."

Regarding Kevetrin, Cellceutix would like to inform shareholders that the fifth cohort has been completed and we anticipate the dosing will be increased for the next cohort.

"We have excellent researchers within our company. As we transition to multiple clinical trials we will be shifting resources to support our focus on clinical programs for Kevetrin, Brilacidin and Prurisol," added Mr. Ehrlich. "We believe that conducting a significant number of clinical trials with our very strong pipeline is the key to fast significant growth at Cellceutix."

About Cellceutix

Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company focused on developing and commercializing its pipeline of compounds for novel therapies in areas of serious unmet medical need, including cancer, psoriasis and antibiotic applications. More information is available on the Cellceutix web site at www.cellceutix.com.

Safe Harbor Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.

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