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MethylGene Receives FDA IND Approval to Begin a Phase 2 Clinical Trial with MGCD290
MethylGene Inc. has announced that it has received approval for its initial Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to start a Phase 2 clinical trial for MGCD290, its oral Hos2 fungal inhibitor, in patients with acute vulvovaginal candidiasis (AVVC), more commonly known as vaginal yeast infection.
This trial (290-005) will enroll approximately 200 women with moderate to severe AVVC and is expected to start enrolling patients by year end.
"The FDA's acceptance of our IND represents an important milestone for this program, and we look forward to announcing the start of randomized, placebo-controlled, Phase 2 clinical trials for MGCD290 in the near future," said Charles Grubsztajn, President and Chief Executive Officer of MethylGene.
Grubsztajn continued, "We expect to report data from this first study in 2012, and to start a second Phase 2 trial with MGCD290 in recurrent vulvovaginal candidiasis in the new year."
