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The European Commission Grants Orphan Drug Designation for Molmed’s Vascular Targeting Agent Arenegyr in the Treatment of Mesothelioma

Friday, June 6, 2008

Source: PharmaLive.com

The European Commission, which is the executive branch of the European Union, has granted “Orphan Drug” status to Arenegyr, an anti-cancer drug currently under investigation for the treatment of mesothelioma, as well as a number of other cancers. Arenegyr is an experimental vascular targeting agent that targets newly-formed tumor blood vessels and disrupts the vascular processes that feed the tumor. At low doses, the agent exhibits its own anti-tumor activity, but it also enhances the efficacy of other anti-cancer drugs used in combination with it. At high doses, it disrupts the vessels and can induce large-scale tumor breakdown and death.

Orphan Drug status is a designation given to therapies designed for uncommon conditions. The EU’s orphan drug status designation is restricted to conditions that occur in less than 5 in 10,000 people. The designation provides a number of benefits to companies developing the therapy and is a given after a therapy has shown some initial successes in clinical trials.

Arenegyr is produced by the Italian pharmaceutical company MolMed S.p.A. and is currently the subject of a number of clinical studies, both as a single-agent therapy and as a combination with therapy. These studies are investigating its use for pleural mesothelioma, colorectal cancer, hepatocarcinoma and small-cell lung carcinoma.

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