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Trials & Filings

Cellceutix Files for Orphan Designation

Defensin mimetic treats oral mucositis in radiation and chemotherapy patients.

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cellceutix Corp. has filed an application with the FDA 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. 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. Preclinical research presented at the 2012 American Society of Clinical Oncology meeting showed that Brilacidin reduced the occurrence of severe ulcerative oral mucositis in animal models by more than 94% 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 FDA, potential for expedited drug development, eligibility for drug grants, tax incentives and extended market exclusivity.

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