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Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkin's Lymphoma
Date:9/24/2007

eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Once approved, the product may qualify for 10 years of marketing exclusivity in the EU.

MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. The compound is currently in two Phase I/II clinical trials, in combination with Vidaza(R) for hematological malignances and with Gemzar(R) in solid tumors; and in four Phase II monotherapy clinical trials in hematological malignancies.

About Hodgkin's Lymphoma

Hodgkin's lymphoma (HL) is a cancer of the lymphatic system that begins in the lymph nodes and progresses to other organs, including the lungs, liver, bone and bone marrow. It is characterized by the presence of Reed-Sternberg cells. Currently, there is no known cause of the disease, but epigenetic alterations including histone acetylation, have been identified. In addition, the Epstein-Barr virus, HIV and familial history are known risk factors. The disease is slightly more prevalent in men than women, and the median age of diagnosis is 38.

About MethylGene

MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I/II combination trials with Vidaza(R) and Gemzar(R). MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; a sirtuins program for cancer; and a beta-lactamase program to overcome antibiotic resistance. Meth
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SOURCE Pharmion Corporation
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