Bionovo initiates Menerba Phase 3 trial in menopausal hot flashes

Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that the first patient has now been randomized and will begin dosing in the Phase 3 pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba™ (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

As announced previously, the Phase 3, multicenter, double-blind, placebo-controlled, randomized clinical trial evaluating Menerba is currently open for enrollment. A total of 50 clinical sites in the U.S. will enroll 1,200 postmenopausal women between the ages of 40 and 65 years. Participants will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. The primary aims of the study are to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment.  Efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment. Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University is serving as the Principal Investigator for the study.