EMERYVILLE, Calif., Dec. 3 Bionovo, Inc.(Nasdaq: BNVI) today announced that the FDA has reviewed the company'smanufacturing and control process descriptions (CMC), and has providedguidance 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 toaddress the Agency's recommendations for further development of Menerba. Therecommendations with respect to the analytical characterization were made bythe Pre-Marketing division of the Agency, in order to ensure continuous drugconsistency. There are some areas of the drug development process requiringfurther discussion on how to best implement the Agency's Guidance for Industryfor Botanical Drug Products. Bionovo will be moving with all possiblediligence to reach agreement on these areas with the FDA. We will startmanufacturing the clinical material using the commercial process immediately.During these discussions no concerns were expressed about either the safetynor the efficacy of Menerba," said Dr. Isaac Cohen, Bionovo's Chairman andCEO.
Bionovo completed a multicenter Phase 2, double-blind, placebo-controlledrandomized clinical trial evaluating Menerba for the treatment of hot flashesin 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 theUniversity of California, San Francisco. Menerba showed a statisticallysignificant reduction in the number of hot flashes after 12 weeks of treatment(-62%, p=0.05) and had a statistically significant reduction in nighttimeawakenings from hot flashes (-67%, p=0.05). There was no difference in uterinebleeding between treatment groups and placebo, and no uterine abnormalitieswere observed during the study. The only side effect observed was mild loosestools (12% in treatment group vs. 3% in the placebo group). To date, nosignificant toxicities have been observed in any of the animal studies withdoses 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. Ourdiscussions with the FDA clinical staff, our Scientific Advisory Board, ourclinical investigators, and our reception at the many scientific conferencesat which we have presented -- all have served to strengthen our confidencethat Bionovo's Menerba will be able to provide menopausal women with a safeand efficacious alternative to the existing drugs on the market. This isparticularly important because all current drugs for hot flashes carry sixblack box warnings by the FDA for potentially serious adverse events. As anext step, we have plans to meet with the clinical review team at the FDA toreach 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 hotflashes. The novel mechanism of action, the exciting preclinical and clinicalsafety, and the early efficacy are encouraging. I believe swift development iswarranted 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 ClinicalInvestigator.
The Company expects to initiate clinical trials by the second quarter of2009 subject to FDA review.
Menerba is an estrogen receptor (ER) beta selective drug developed as analternative to postmenopausal hormone products currently on the market, whichare both ER beta and ER alpha agonists that have been shown to increase therisk for breast and uterine cancers. It has been shown that the increased riskof breast and uterine cancers is associated with ER alpha activation and thatER beta blocks the growth promoting effects on breast cancer cells. Bionovorecognized the opportunity to commercialize a product that would be equallyeffective, with an improved safety profile compared to traditional hormonetherapy. The clinical trial results have been evaluated by an independent Dataand Safety Monitoring Board and the drug candidate has passed through astandard two-phase examination for safety.
Bionovo is a pharmaceutical company focused on the discovery anddevelopment of safe and effective treatments for women's health and cancer,markets with significant unmet needs and billions in potential annual revenue.The company applies its expertise in the biology of menopause and cancer todesign new drugs derived from botanical sources which have novel mechanisms ofaction. Based on the results of early and mid-stage clinical trials, Bionovobelieves they have discovered new classes of drug candidates within their richpipeline with the potential to be leaders in their markets. Bionovo isheadquartered in Emeryville, California and is traded on the NASDAQ CapitalMarket under the symbol, "BNVI". For more information about Bionovo and itsprograms, visit http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to thebusiness of Bionovo, Inc. that can be identified by the use of forward-lookingterminology such as "believes," "expects," or similar expressions. Suchforward-looking statements involve known and unknown risks and uncertainties,including uncertainties relating to product development, efficacy and safety,regulatory actions or delays, the ability to obtain or maintain patent orother proprietary intellectual property protection, market acceptance,physician acceptance, third party reimbursement, future capital requirements,competition in general and other factors that may cause actual results to bematerially different from those described herein as anticipated, believed,estimated or expected. Certain of these risks and uncertainties are or will bedescribed in greater detail in our filings with the Securities and ExchangeCommission, which are available at http://www.sec.gov. Bionovo, Inc. is underno obligation (and expressly disclaims any such obligation) to update or alterits forward-looking statements whether as a result of new information, futureevents or otherwise.
SOURCE Bionovo, Inc.