ActivBiotics Receives Orphan Drug Designation from the European Medicines Agency for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis ...( WELLESLEY HILLS Mass. Feb. 5 /- J...),Health

WELLESLEY HILLS, Mass., Feb. 5 /PRNewswire/ -- Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced today that The Committee for Orphan Drug Products of the European Medicines Agency (EMEA) has granted Orphan Drug Designation for M40403 for the prevention of oral mucositis (OM) in head and neck cancer patients receiving radiotherapy.

The development of oral mucositis during radiation therapy of head and neck cancers is the major reason for poor compliance with and early discontinuation of radiation therapy by patients being treated for their condition.

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 5 in 10,000 persons in the European Union. Orphan Drug Designation provides an important economic incentive for the development of new products in the cancer field. EU Orphan Designation provides for 10 years of market exclusivity, reduction in EU regulatory fees, and additional regulatory support for R&D initiatives.

ActivBiotics has also applied for Orphan Drug Designation with the U.S. Food and Drug Administration.

About M40403

This investigational small molecule mimics the action of a natural component of the cells, an enzyme called superoxide dismutase. Superoxide dismutase is thought to have a double effect, first through the reduction of inflammation, and secondarily through the decreased rate of programmed cell death (apoptosis). As mucositis involves inflammation, the positive effect of the M40403 over this process is expected to have a beneficial effect in the condition. 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
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