EMERYVILLE, Calif., Aug. 3, 2011 /PRNewswire/ -- Bionovo, Inc. (NASDAQ: BNVI) today announced second quarter highlights and financial results for the three months ended June 30, 2011.
"We have made excellent progress on our menopausal hot flash drug candidate, MF101, or Menerba™, during the past quarter, delivering on milestones and commitments," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We have completed the tasks which were required for us to begin the phase 3 clinical trial for Menerba, and we are on track to initiate the trial in the third quarter."
Key Events and MilestonesThe Company successfully completed non-clinical toxicology studies of Menerba in two animal species. As expected no serious adverse events or toxicities were observed in these studies. The drug was well tolerated by the animals. The Company successfully completed a 28-day tolerability trial of Menerba in women, investigating higher doses. As expected, there were no safety concerns, no reports of serious adverse events, no changes to blood pressure, heart rate or lab values and no cases of abnormal uterine findings on endometrial biopsies. A dosing strategy has been established for the phase 3 study. The Company completed the manufacture of the requisite ten batches for the phase 3 clinical trial of Menerba, and is preparing the submission of data to the FDA. The Company has identified, selected, and is working with personnel at 45 initial clinical trial sites for the phase 3 clinical trial of Menerba. The Company also published further information on the mechanism of action of its breast cancer drug candidate, Bezielle™, as well as further information on novel approaches for the quantification of actives in botanical drug mixtures. The Company presented data from the Phase 2