EMERYVILLE, Calif., Aug. 5, 2011 /PRNewswire/ — CORRECTED —
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 Milestones
The 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
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