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news.The Committee for Orphan Drug Products of the European Medicines Agency has granted orphan drug designation for ActivBiotics's M40403 for the prevention of oral mucositis in head and neck cancer patients receiving radiotherapy.
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According to ActivBiotics, 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, the company said.
European Union Orphan Drug Designation was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect not more than five in 10,000 persons in the European Union.