BioNovo, Inc.'s Independent Data Safety Monitoring Board Recommends Continuation of Phase 3 Study for Menerba™
Published: Mar 28, 2012
EMERYVILLE, Calif., March 28, 2012 /PRNewswire/ -- Bionovo, Inc. (OTCQB: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today that the Company's independent Data Safety Monitoring Board (DSMB) recommended that the Phase 3 trial of Menerba (MF101) could continue as designed after an initial review of its clinical safety and tolerability data. Menerba is Bionovo's oral botanical drug candidate designed for the safe and effective treatment of vasomotor symptoms (hot flashes) associated with menopause.
The DSMB evaluated unblinded safety and dose tolerability data after 66 participants were randomized and on study medication for at least 30 days. After an independent review of the data, the DSMB issued their positive recommendation to continue the trial as originally designed and no concerning safety signals were identified.
"I am very encouraged by the positive recommendation from our independent DSMB. This assurance that Menerba continues to be a safe, well-tolerated, non-estrogen alternative therapy for the treatment of menopausal hot flashes is consistent with the promising results of our early clinical trial data and extensive pre-clinical toxicity studies. We are very eager to continue to develop a safe and effective treatment for post-menopausal hot flashes, a drug that can be the leading seller in the well established multibillion dollar market," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
The MF101-004 Phase 3 pivotal study dosed its first patient on November 16, 2011. To date, a total of 280 postmenopausal women have been randomized to the trial. Recruitment to the Phase 3 trial was voluntarily halted on March 9, 2012 as Bionovo does not have adequate funding to further advance the registration trial. Bionovo will need to secure additional financing to complete either a smaller Phase 2B trial with the current cohort of 280 randomized participants or to complete the planned Phase 3 study.
The purpose of the study is to evaluate the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes. (Logo: http://photos.prnewswire.com/prnh/20111110/SF04662LOGO)
Participants are randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. Efficacy will be measured by the reduction of moderate to severe hot flashes 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 this study.
Menerba is an oral drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause, which is manufactured from botanical sources. 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 2 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.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development 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 to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California. For more information about Bionovo and its programs, visit: http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-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 or other 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 be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise
SOURCE Bionovo, Inc.