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Bionovo's MF101 Shows Positive Safety, Tolerability and Efficacy in,Phase 2 Trial

severity of hot flashes than the lower dose.

In secondary analyses, the percent of women reporting greater than 50% reduction in all hot flashes was statistically significantly higher in the MF101 high dose group compared to placebo (p=0.03) and in both doses of MF101 combined compared to placebo (p=0.05).

MF101 is a novel estrogen receptor beta agonist that is expected not to stimulate the endometrium or breast tissue. Safety analyses showed no cases of endometrial hyperplasia or uterine cancer during the trial and there were no differences in incidence of vaginal bleeding between the placebo group and the two cohorts treated with MF101. The only side effect that increased with MF101 treatment was loose stool/diarrhea (12% in each of the drug arms vs. 3% in placebo arm). Constipation was improved with MF101 therapy. These observations are consistent with the presence of soluble fiber in the drug extract, which future optimization of the manufacturing process will significantly reduce. Adherence to the study medication was high with 91% of the participants compliant with treatment after 12 weeks of therapy.

"I am very encouraged and pleased by the findings of this clinical trial," said Deborah Grady, M.D., Associate Dean for Clinical and Translational Science, Professor of Medicine and Director of the University of California, San Francisco (UCSF) Women's Health Clinical Research Center. "The combination of a trend to better efficacy with a higher dose of MF101 and a very strong safety profile of a drug that was very well tolerated by menopausal women is exciting news. These early positive clinical results are not only encouraging for discovering a safer therapy for hot flashes but also support the role of estrogen receptor beta as a novel target for treating menopausal symptoms."

"Recent clinical trials, such as the HERS and the WHI, elucidated important safety concerns of postmenopau
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