Bionovo intiates Ph II PKC trial of MF101
USA-based Bionovo has begun enrollment for a single ascending-dose pharmacokinetics trial to further evaluate the company's lead drug candidate, MF101, designed to treat the symptoms of menopause.
A total of 184 post-menopausal women out of 217 were randomized into the double-blind, placebo-controlled Phase II study, initiated in October 2006, and have now completed their 12-week, off-study medication visit. To date, there have been no cases of uterine hyperplasia or uterine cancer during the trial, Bionovo noted, adding that adherence to the study medication has been high, with a less than 10% drop out rate.
The company expects to have full results from the Phase II trial in the second quarter of 2007.
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