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news.MethylGene has completed subject enrollment in Phase II trial of MGCD290, a small molecule inhibitor of the fungal enzyme Hos2.
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The multi-center Trial 290-005 is designed to assess MGCD290 in combination with fluconazole against only fluconazole in vulvovaginal candidiasis (VVC) patients.
MethylGene president and chief executive officer Dr. Chuck Baum said, "MGCD290 is a novel antifungal agent with the potential to significantly improve outcomes for patients suffering from fungal infections, including VVC."
The primary endpoint of the double-blind, placebo-controlled trial that enrolled more than 200 VVC patients in North America is therapeutic cure at Day 28, which is a combined endpoint of clinical cure and mycological cure.
Clinical and mycological cure rates at Day 14 and Day 28, therapeutic, clinical and mycological cure rates at day 14, recurrence rate at Day 28, and time to recurrence are the secondary endpoints.
Company anticipates reporting topline data in March 2013.