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Cellceutix (CTIX) Files Orphan Drug Designation Application For Brilacidin For Oral Mucositis With U.S. FDA


12/23/2013 10:01:57 AM

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BEVERLY, MA--(Marketwired - December 20, 2013) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that it has filed an application with the U.S. Food and Drug Administration requesting Orphan Drug designation for its novel antibiotic Brilacidin™-OM as a drug candidate for the prevention of radiation or chemotherapy-induced oral mucositis in head and neck cancer.

Brilacidin-OM is a defensin mimetic that has antibacterial, anti-biofilm and anti-inflammatory properties. Currently, the Company is planning a Phase II trial of Brilacidin-OM to meet an area of great unmet medical need for cancer patients that suffer from the condition which is a common, and often debilitating, side effect of chemotherapy and radiology therapy. Preclinical research presented at the 2012 American Society of Clinical Oncology meeting showed that Brilacidin reduced the occurrence of sever ulcerative oral mucositis in animal models by more than 94 percent compared to placebo.

Orphan drug designation is intended to facilitate drug development for drugs that target conditions affecting fewer than 200,000 patients in the United States each year, while providing a significant therapeutic advantage over existing therapies. The designation carries several benefits, including fee reductions, assistance in study design from the Food and Drug Administration, potential for expedited drug development, eligibility for drug grants, tax incentives and extended market exclusivity.

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 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

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:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
Email Contact



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