Bionovo completes 13 weeks repeat dose animal toxicology studies for Menerba

Jul 25 2011

Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today the successful completion of 13 weeks repeat dose animal toxicology studies with Menerba.

"Prior to Phase 3 initiation we were required by FDA to complete two 13 weeks repeat dose animal toxicology studies," commented Dr. Isaac Cohen, chairman and chief executive officer of Bionovo, Inc. "These studies were one of three requirements Bionovo had to complete prior to initiation of the Phase 3 studies. As expected no serious adverse events or toxicities were observed so far from these studies. The drug was well tolerated by the animals. We are therefore on track to initiate the Phase 3 in the third quarter of this year."

Menerba at doses far greater than the planned human doses were administered to the animals daily for 13 weeks. None of the animals died during the studies, and no serious untoward effects were observed. No pathological changes in urinalysis, blood chemistry and blood counts were observed. Also, no serious pathologies were observed in all tissues that were examined.