Transgene announced that the European Commission has approved the designation of Transgene's immunotherapy product candidate Adeno-Interferon gamma (Ad-IFN gamma) as an "Orphan Medicinal Product" for the treatment of cutaneous T-cell lymphoma (CTCL), following the positive opinion of the Committee for Orphan Medicinal Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).

The Committee for Orphan Medicinal Products of the EMEA found that Transgene's Ad-IFN gamma may be of significant benefit to patients affected by CTCL, particularly with respect to improved efficacy based on preliminary clinical results.

The European orphan drug designation promotes development of drugs to treat rare diseases or life-threatening conditions by providing marketing exclusivity to approved orphan products for ten years following regulatory approval, as well as protocol assistance by the EMEA for the development of the product.

"This European orphan drug designation may allow patient access to an improved therapy within an accelerated timeframe," stated Patrick Squiban, Transgene Vice-President for Medical and Regulatory Affairs. "It will give us the opportunity to interact with the regulatory authorities for the preparation of an optimized clinical development plan."