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news.ActivBiotics has reported that the Office of Orphan Products Development of the FDA has granted orphan drug designation for M40403 for the prevention of radiation or chemotherapy-induced oral mucositis in cancer patients.
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By targeting various early stage inflammatory pathways implicated in the development of oral mucositis, M40403 may have particularly unique potential as a successful therapeutic in this disorder. M40403 has shown efficacy in an animal model where oral mucositis was induced by acute irradiation. The compound has been evaluated in approximately 700 subjects in several Phase I and II clinical trials, and was shown to be safe and well-tolerated.
FDA’s Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and treatment of life-threatening or very serious conditions that are rare and affect not more than 200,000 persons in the US.