Adeno-interferon gamma product candidate receives orphan drug designation.

2003 AUG 20 - (NewsRx.com & NewsRx.net) -- Transgene has 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 10 years following regulatory approval, as well as protocol assistance by the EMEA for the development of the product.

CTCL encompasses a spectrum of diseases defined by a malignant clonal proliferation of cutaneous lymphocytes. With a prevalence of six patients per 100,000 people in European countries, CTCL ranks second to melanoma as the most frequent dermatologic life-threatening diseases. CTCL is characterized by its heterogeneity of clinical presentations, prognoses and therapeutic options.

Due to their heterogeneity, there are no universally applicable guidelines available for the treatment of cutaneous T-cell lymphomas. In contrast with the excellent chance of cure at early stage, advanced disease is marked by burdensome, debilitating tumors and a fatal outcome ...