"I am extremely pleased by the positive findings from our study which continue to show that Menerba is a safe therapy for the treatment of menopausal hot flashes. As predicted by the dose response seen in our Phase 2 trial, higher doses of Menerba tested in our Phase 1 study demonstrated higher efficacy. We were encouraged by the robust clinical effect of Menerba to reduce hot flashes after just 4 weeks of treatment," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "The participants enrolled to the trial had an average number of 73 weekly hot flashes at baseline. After 4 weeks on therapy, the reduction in moderate to severe hot flashes was approximately 70% with a p value of 0.003 for women who took a dose of Menerba that has twice the potency than the highest dose tested in our Phase 2 study. In addition, there was a 68% reduction in the number of nighttime awakenings due to hot flashes with a p value of 0.001. This level of efficacy at 4 weeks is similar to estrogen-based hormone therapy. Moving forward, we will evaluate two doses of Menerba compared to placebo in a definitive Phase 3 randomized, double-blind, placebo-controlled clinical trial."

"We are pleased to report that we continue to meet our stated timelines for the year. We have determined a clear dosing strategy for the upcoming Phase 3 trial of Menerba and we are very encouraged by the totality of our safety and efficacy data from this trial. To this end, we are eager to initiate the Phase 3 clinical trial this fall," stated Dr. Isaac Cohen, Chairman and Chief Executive Officer of Bionovo.

SOURCE Bionovo, Inc.