Kinesys Consulting Ltd is pleased to announce that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to SGX301(synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare disease and a class of non-Hodgkin’s lymphoma, a type of cancer of the white blood cells that are an integral part of the immune system. SGX301 has previously been granted both orphan drug and fast track designations from the US Food and Drug Administration (FDA) for the first-line treatment of CTCL.
Kinesys has secured this designation on behalf of its US partner Soligenix, Inc., New Jersey. Soligenix has a number of products for serious or life-threatening diseases entering late stage clinical development, including SGX301.
Please see the Soligenix (CTCL slide press release on this subject containing information relating to forward looking statements: http://www.soligenix.com/news.aspx?titleId=489)