BEVERLY, MA -- (Marketwired) -- 01/06/14 -- 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 today submitted the application to the Institutional Review Board ("IRB") responsible for the planned clinical study of the Company's psoriasis drug Prurisol.
The trial is a short crossover study being conducted at the request of the U.S. Food and Drug Administration ("FDA") with the purpose of demonstrating that Prurisol, an ester of abacavir, converts into abacavir in humans, just as it did in animal models. Once IRB approval is received, Cellceutix will immediately file an Investigational New Drug (IND) Application with the FDA. The trial is expected to take approximately one and a half months to complete, at which time the Company will move forward with initiation of a larger Phase 2/3 trial under the guidance from the FDA that a 505(b)(2) designation is an appropriate developmental pathway for Prurisol.
"Submitting the application to the IRB to begin clinical trials of Prurisol is a fantastic way to begin the year," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We are excited to kick-off 2014 with Prurisol moving into human studies, our novel antibiotic Brilacidin commencing a Phase 2b trial in January, and Kevetrin, our flagship anti-cancer drug, reaching the latter stages of its Phase 1 trial. These trials represent our unwavering commitment to build shareholder value and bring new drugs to market spanning several areas of great unmet medical need."
Cellceutix will be providing a comprehensive update on all of its pipeline developments at the Biotech Showcase 2014 conference being held in San Francisco, California, January 13-15.
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.