Bionovo (BNVI) Reports Flat Results in Menerba Phase 2
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Bionovo, Inc. (Nasdaq: BNVI), reports positive results from the completion of their tolerability trial of Menerba (MF101) for menopausal hot flashes.
The open-label, randomized, clinical trial of Menerba was conducted at four U.S. clinical sites. Postmenopausal women between the ages of 40 and 65 years were randomized to one of two doses of Menerba and treated for 28 days. The primary goal of the study was to assess the safety and tolerability of two doses of Menerba, higher than those previously tested during the Phase 2 studies, after 4 weeks of treatment. This study allowed Bionovo to identify the optimal dosages for the planned Phase 3 studies. Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University served as the Principal Investigator for the study.
A total of 35 postmenopausal women with an average age of 53, who at baseline had on average 73 hot flashes per week, were enrolled to the trial. The primary endpoint of the study was to test the safety of two higher doses of Menerba. There were no reported cases of serious adverse events, no abnormal findings on endometrial biopsies, no abnormal lab results, no changes to blood pressure, heart rate or weight and no concerning side effects from the treatments. The Company has established a definitive dosing strategy for the Phase 3 clinical trial.
The open-label, randomized, clinical trial of Menerba was conducted at four U.S. clinical sites. Postmenopausal women between the ages of 40 and 65 years were randomized to one of two doses of Menerba and treated for 28 days. The primary goal of the study was to assess the safety and tolerability of two doses of Menerba, higher than those previously tested during the Phase 2 studies, after 4 weeks of treatment. This study allowed Bionovo to identify the optimal dosages for the planned Phase 3 studies. Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University served as the Principal Investigator for the study.
A total of 35 postmenopausal women with an average age of 53, who at baseline had on average 73 hot flashes per week, were enrolled to the trial. The primary endpoint of the study was to test the safety of two higher doses of Menerba. There were no reported cases of serious adverse events, no abnormal findings on endometrial biopsies, no abnormal lab results, no changes to blood pressure, heart rate or weight and no concerning side effects from the treatments. The Company has established a definitive dosing strategy for the Phase 3 clinical trial.
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