Cellceutix Submits Application for IRB Review to Commence Phase 2b Clinical Trial of Novel Antibiotic Brilacidin
BEVERLY, MA—Dec 16, 2013 – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that it has submitted the application to the Institutional Review Board (“IRB”) responsible for the Company’s planned Phase 2b clinical trial of its novel antibiotic Brilacidin as a drug candidate for Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”).
The protocol for the clinical trial was constructed following the successful completion of a Phase 2a clinical trial of Brilacidin for ABSSSI. The Company anticipates that the trials will commence on schedule in just a few weeks, in January 2014. The clinical trial information will soon be updated on www.clinicaltrials.gov
Cellceutix is particularly excited about the timing of its recent acquisition of novel antibiotic and antifungal compounds because of the introduction last week of the ADAPT (Antibiotic Development to Advance Patient Treatment) Act of 2013 by the House of Representatives to expedite development of new antibiotics and antifungal drug candidates. The bill builds upon the GAIN (Generating Antibiotic Incentives Now) Act that was passed in 2012 to provide incentives, such as extended periods of exclusivity and smaller patient populations for clinical trials, for new antibiotics that target areas of great unmet medical need. The FDA is demonstrating its commitment to find solutions to the growing problem of bacteria infections. Cellceutix feels its drug candidates are prime candidates to benefit from these government initiatives.
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 oncology, dermatology and antibiotic applications. 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 planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is being readied for clinical trials at sites in the U.S. and Europe. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, is set to begin a Phase 2b trial in January 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria or a dosing regimen that is shorter than currently marketed antibiotics. 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
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.
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