October 3, 2008

Methylgene Wins Canadian Approval for Phase I Fungal Drug

MethylGene, a clinical stage biopharmaceutical company, has announced that Health Canada has approved the company's clinical trial application for MGCD290, a fungal Hos2 histone deacetylase inhibitor to be used in combination with azoles for the treatment of fungal infections.

MethylGene expects to initiate a Phase I clinical trial in Canada in October 2008. The goal of this trial will be to assess the safety, pharmacokinetics and tolerability of the compound in healthy volunteers. MGCD290 will initially be administered orally as a single-agent and, in future planned studies, in combination with oral fluconazole, a widely used antifungal agent.

In preclinical studies, MGCD290 in combination with fluconazole increased fungal sensitivity and broadened the spectrum of azole activity in vitro against human fungal pathogens, including azole-resistant clinical isolates, the company said.

Donald Corcoran, president and CEO of MethylGene, said: "MGCD290 is our first Hos2 histone deacetylase (HDAC) inhibitor for use outside of oncology. MGCD290 differs from our anticancer HDAC compounds in that it targets the fungal enzyme, Hos2, that is distinct from human HDACs. In addition, it is from a different chemical family than that of our current cancer compounds."