Image taken from Cellceutix’s website.
Cellceutix Corp., a Beverly-based biopharmaceutical company, said Friday that it has filed an application with the Food and Drug Administration requesting orphan drug designation for a drug candidate designed to treat some of the side effects of radiation and chemotherapy for patients with certain types of cancer.
To encourage companies to develop drugs for diseases and conditions that afflict fewer than 200,000 people nationwide, the FDA provides incentives to do the expensive research needed to bring such drugs to market. The designation carries several benefits for a drug company, including reduced fees, FDA assistance in study design, the potential for expedited drug development, eligibility for drug grants, tax incentives, and extended market exclusivity. (But even after orphan drug status is granted, a drug still needs to get FDA approval.)
In its Friday press release, Cellceutix said it is seeking orphan drug status for an antibiotic called Brilacidin-OM, which can prevent radiation or chemotherapy-induced oral mucositis in patients with head and neck cancer.