BOULDER, Colo. and MONTREAL, Sept. 24 PharmionCorporation (Nasdaq: PHRM) and MethylGene, Inc. (TSX: MYG) today announcedthat the European Medicines Agency (EMEA) and the European Commission (EC)designated MGCD0103, a histone deacetylase (HDAC) inhibitor, as an OrphanMedicinal Product for the treatment of Hodgkin's lymphoma in the EuropeanUnion (EU). Criteria for designation require that the product be intended forthe treatment of life-threatening or serious conditions that are rare andaffect not more than five in 10,000 persons in the EU.
Preliminary data from a MGCD0103 Phase II monotherapy clinical trial inrelapsed and refractory Hodgkin's lymphoma were presented at the AmericanSociety of Clinical Oncology 2007 Annual Meeting in June and were included inthe application for orphan drug designation. The data demonstrated anobjective complete response (CR) plus partial response (PR) rate of 40 percentand a disease control rate (CR + PR + stable disease for > 6 cycles) of 45percent in a population of 20 evaluable patients that had relapsed disease orwere refractory (unresponsive) to all previous treatments, including, in mostcases, bone marrow transplantation. Fatigue and gastrointestinal side effectswere the most common adverse events and dose modification was effective inmany of these patients.
Orphan Medicinal Product Designation allows special incentives forsponsors planning to test a product for use in a rare disease or conditiongenerally characterized by a small number of patients. These incentivesinclude eligibility for protocol assistance and possible exemptions orreductions of certain regulatory fees during development or at the time ofapplication for marketing approval. Once approved, the product may qualifyfor 10 years of marketing exclusivity in the EU.
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. Thecompound is currently in two Phase I/II clinical trials, in combination withVidaza(R) for hematological malignances and with Gemzar(R) in solid tumors;and in four Phase II monotherapy clinical trials in hematologicalmalignancies.
About Hodgkin's Lymphoma
Hodgkin's lymphoma (HL) is a cancer of the lymphatic system that begins inthe lymph nodes and progresses to other organs, including the lungs, liver,bone and bone marrow. It is characterized by the presence of Reed-Sternbergcells. Currently, there is no known cause of the disease, but epigeneticalterations including histone acetylation, have been identified. In addition,the Epstein-Barr virus, HIV and familial history are known risk factors. Thedisease is slightly more prevalent in men than women, and the median age ofdiagnosis is 38.
MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical companyfocused on the discovery, development and commercialization of noveltherapeutics for cancer. The Company's lead product, MGCD0103, is an oralisotype-selective HDAC inhibitor presently in multiple clinical trials forsolid tumors and hematological malignancies, including Phase II monotherapyand Phase I/II combination trials with Vidaza(R) and Gemzar(R). MGCD265 is anoral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptortyrosine kinases. In addition, MethylGene has several preclinical programs:MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; anHDAC program for Huntington's disease; a sirtuins program for cancer; and abeta-lactamase program to overcome antibiotic resistance. MethylGene'sdevelopment and commercialization partners include Pharmion Corporation, TaihoPharmaceutical and EnVivo Pharmaceuticals. Please visit our website athttp://www.methylgene.com.
Pharmion is a leading global oncology company focused on acquiring,developing and commercializing innovative products for the treatment ofhematology and oncology patients in th