ORPHAN DRUG DESIGNATION SOUGHT FOR ADVEXIN IN EUROPE

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Gendux AB and Intorgen Therapeutics have submitted an orphan drug designation request to the European Medicines Agency (EMEA) for the use of Advexin p53 to treat cancer patients with Li-Fraumeni Syndrome.

The orphan drug status will provide the drug with an expedited and streamlined EMEA review process the companies said. Advexin p53 selectively kills cancer cells by providing high concentrations of the protein p53, a known tumor suppressor, according to the announcement.

Li-Fraumeni Syndrome is a rare genetic disorder rendering the patient at risk of developing several types of cancer, usually at a young age.