SOURCE: Cellceutix

Cellceutix

February 09, 2016 09:25 ET

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

BEVERLY, MA--(Marketwired - February 09, 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."

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About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email contact