Bionovo Announces Development Plans For Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
Emeryville, CA - Bionovo, Inc. recently announced that the FDA has reviewed the company's manufacturing and control process descriptions (CMC), and has provided guidance on how Bionovo can move forward with the development of Menerba (formerly named MF101) for menopausal hot flashes.
"We have concluded three CMC discussions with the FDA, and are moving to address the Agency's recommendations for further development of Menerba. The recommendations with respect to the analytical characterization were made by the Pre-Marketing division of the Agency, in order to ensure continuous drug consistency. There are some areas of the drug development process requiring further discussion on how to best implement the Agency's Guidance for Industry for Botanical Drug Products. Bionovo will be moving with all possible diligence to reach agreement on these areas with the FDA. We will start manufacturing the clinical material using the commercial process immediately. During these discussions no concerns were expressed about either the safety nor the efficacy of Menerba," said Dr. Isaac Cohen, Bionovo's Chairman and CEO.
Bionovo completed a multicenter Phase 2, double-blind, placebo-controlled randomized clinical trial evaluating Menerba for the treatment of hot flashes in 217 healthy post-menopausal women enrolled at 6 clinical sites in the U.S. The principal investigator of the trial was Dr. Deborah Grady from the University of California, San Francisco. Menerba showed a statistically significant reduction in the number of hot flashes after 12 weeks of treatment (-62%, p=0.05) and had a statistically significant reduction in nighttime awakenings from hot flashes (-67%, p=0.05). There was no difference in uterine bleeding between treatment groups and placebo, and no uterine abnormalities were observed during the study. The only side effect observed was mild loose stools (12% in treatment group vs. 3% in the placebo group). To date, no significant toxicities have been observed in any of the animal studies with doses ranging from 2000 mg/kg/day in dogs to 16,000 mg/kg/day in rodents.
"The positive results of Menerba to date are very encouraging. Our discussions with the FDA clinical staff, our Scientific Advisory Board, our clinical investigators, and our reception at the many scientific conferences at which we have presented -- all have served to strengthen our confidence that Bionovo's Menerba will be able to provide menopausal women with a safe and efficacious alternative to the existing drugs on the market. This is particularly important because all current drugs for hot flashes carry six black box warnings by the FDA for potentially serious adverse events. As a next step, we have plans to meet with the clinical review team at the FDA to reach an agreement on the clinical path forward," said Dr. Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
"Menerba provides a true paradigm shift in the treatment of menopausal hot flashes. The novel mechanism of action, the exciting preclinical and clinical safety, and the early efficacy are encouraging. I believe swift development is warranted so we can provide women with an alternative to hormone therapy," said Wulf Utian, M.D., Ph.D., D.Sc. Founder and President Emeritus of the North American Menopause Society and Menerba's Principal Clinical Investigator.
The Company expects to initiate clinical trials by the second quarter of 2009 subject to FDA review.
SOURCE: Bionovo, Inc.