Methylgene to Resume Development of MGCD0103 (Mocetinostat)
Worldwide Biotech 2009, Nov 1, 21, 11
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Publisher Description
MethylGene Inc. (TSX:MYG), Montreal, Quebec. has announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on MGCD0103, the company's proprietary selective histone deacetylase (HDAC) inhibitor for cancer. New patient enrollment in the refractory follicular lymphoma cohort of the company's ongoing Phase II clinical trial (Trial 008) is expected to resume as soon as possible. "We are pleased with the FDA's action," said Donald F. Corcoran, president and CEO of MethylGene. "The lifting of the partial clinical hold opens the door to enrolling new patients as well as to further evaluate the development pathways, partnering opportunities and financing options for MGCD0103. The implementation of measures to monitor for pericarditis and pericardial effusion is expected to be relatively straightforward. As previously disclosed at various scientific meetings and in publications, HDAC inhibitors generally, and MGCD0103 in particular, have demonstrated efficacy in a number of tumor types as single agents and in combination therapies. We believe our compound remains a promising opportunity for the treatment of various cancers."