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."