- Follows the Companies' Previous Announcement of MGCD0103's Orphan Drug Designation for the Treatment of Hodgkin's Lymphoma in the United States -
BOULDER, Colo. and MONTREAL, Sept. 24 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) and MethylGene, Inc. (TSX: MYG) today announced that the European Medicines Agency (EMEA) and the European Commission (EC) designated MGCD0103, a histone deacetylase (HDAC) inhibitor, as an Orphan Medicinal Product for the treatment of Hodgkin's lymphoma in the European Union (EU). Criteria for designation require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than five in 10,000 persons in the EU.
Preliminary data from a MGCD0103 Phase II monotherapy clinical trial in relapsed and refractory Hodgkin's lymphoma were presented at the American Society of Clinical Oncology 2007 Annual Meeting in June and were included in the application for orphan drug designation. The data demonstrated an objective complete response (CR) plus partial response (PR) rate of 40 percent and a disease control rate (CR + PR + stable disease for > 6 cycles) of 45 percent in a population of 20 evaluable patients that had relapsed disease or were refractory (unresponsive) to all previous treatments, including, in most cases, bone marrow transplantation. Fatigue and gastrointestinal side effects were the most common adverse events and dose modification was effective in many of these patients.
Orphan Medicinal Product Designation allows special incentives for
sponsors planning to test a product for use in a rare disease or condition
generally characterized by a small number of patients. These incentives
|SOURCE Pharmion Corporation|
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