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

“Prior to phase III 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 III 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.

Menerba is an oral botanical drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells.

The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in Traditional Chinese Medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks. Menerba has completed a phase II trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.