MethylGene initiates first phase I blood cancers trial

MGCD0103 is a rationally designed isotypic selective small molecule inhibitor of histone deacetylase (HDAC). The second hematologic cancer trial is scheduled to be initiated in early 2005. Both trials seek to determine the safety, pharmacokinetics, pharmocodynamics and tolerability of MGCD0103 in patients with leukemias or myelodysplastic syndrome.

Each trial is expected to enroll between 18-25 patients and the company expects to enroll the first patients in early 2005.

For the first trial, MGCD0103 will be given orally three times per week for a three-week cycle. For the second trial, MGCD0103 will be given orally twice weekly for a three-week cycle. These two dosing schedules are based on data and observations obtained from two ongoing monotherapy solid tumor trials with MGCD0103.

“HDAC inhibitors are rapidly gaining recognition as a promising new strategy to fight cancers,” said Donald Corcoran, president & CEO at MethylGene. “These trials are part of a robust clinical program we have designed for MGCD0103, which also includes two dose-escalating phase I monotherapy clinical trials in solid tumors which are ongoing in Canada and the US.”

MethylGene’s small molecule HDAC program for oncology, including MGCD0103 and its analogues, is licensed to Taiho Pharmaceutical for Japan, China, Taiwan and Korea. In exchange for development and commercialization rights, Taiho provides MethylGene with contract payments that could total up to $37.5 million, which includes pre-clinical and clinical support for the development of MGCD0103 for North America.