Montreal, Canada, March, 18, 2013 – MethylGene Inc. (TSX:MYG) today reported topline results from its human efficacy trial (Trial 290-005) with MGCD290, a novel antifungal agent targeting the fungal enzyme, Hos2. Trial 290-005 was a randomized, multicenter, double-blind, placebo-controlled trial designed to test whether MGCD290, in combination with fluconazole, was superior to fluconazole alone in patients with moderate-to-severe vulvovaginal candidiasis (“VVC”).
The study showed no statistically significant benefit of MGCD290 plus fluconazole compared to fluconazole alone. There were no serious treatment-related adverse events and non-serious adverse events were evenly distributed between treatment groups. This clinical trial was conducted across nineteen sites in the USA and enrolled 171 patients with positive fungal cultures in their vaginal fluid at baseline. Detailed data will be presented at a future meeting.
"We are disappointed that the study did not demonstrate efficacy of MGCD290 in patients with VVC. We will review the data internally and with key opinion leaders to determine the next steps for the MGCD290 program." said Dr. Charles Baum, President and Chief Executive Officer of MethylGene. “The company’s primary focus will continue to be the advancement of our novel oncology compounds. We expect to provide further updates on the oncology programs in the second half of 2013."
MGCD290 is a first-in-class, orally available, small molecule inhibitor of the fungal enzyme Hos2. In preclinical models the combination with azole antifungal agents results in broader coverage of fungal pathogens and decreases resistance to the most widely used antifungal agents. MGCD290 was being developed as a combination product with fluconazole, the most widely used triazole antifungal. In vitro, MGCD290 in combination with fluconazole reverses fluconazole resistance (primary and acquired) in a wide range of fungal species, including Candida glabrata. MGCD290 has completed multiple Phase I studies in healthy adult volunteers and has shown an excellent safety profile without drug-drug interactions in combination with fluconazole.
MethylGene Inc. (TSX:MYG) is a drug development company that is advancing novel therapeutics for the treatment of patients with cancer and infectious disease in human clinical trials. The Company’s lead product candidates are: MGCD290, an oral antifungal agent targeting the fungal Hos2 enzyme that was in Phase II trials for vulvovaginal candidiasis, and MGCD265, a multi-targeted receptor tyrosine kinase inhibitor that is in Phase I/II clinical trials for patients with solid tumors. MethylGene owns all rights to its lead product candidates, and has partnerships with Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc. for its other pipeline programs.
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