"We had a very positive meeting with the FDA to discuss the clinical program for Menerba. The Agency agreed with our overall clinical and non- clinical development plan for approval. The Agency did suggest a change to the clinical development plan which will allow for faster and more efficient initiation of the pivotal testing, by introducing a small Phase 1 study before the first Phase 3 study, which includes a dose 3 times higher than previously tested in the Phase 2," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
"In order to reach higher efficacy we are evaluating the higher dose of Menerba in the first Phase 3 trial. The FDA would like to see additional safety data to assess this dose. We had originally proposed to the FDA to use the first 60 patients enrolled in our first Phase 3 study as subjects for safety evaluation. The protocol would have required enrollment to be suspended after 60 patients had been enrolled. Enrollment to study would continue only once an independent data and safety monitoring board (DSMB) had reviewed the safety data and deemed there were no safety issues," continued Dr. Tagliaferri.
"However, the Agency instead recommended, and we agreed to conduct, a Phase 1 study in advance of the Phase 3 study. The Phase 1 open label trial will enroll 20 postmenopausal women who will all receive Menerba 15g/day (7.5g BID) for 28 days. This approach will allow us to expedite the initiation of the Phase 3 trial, since we will no longer have to halt enrollment after 60 patients are accrued to the trial to allow the DSMB to review safety data. We will be able to complete the Phase 1 study at the same time the required 13-week animal toxicology studies are being conducted and while the Phase 3 clinical trial material is manufactured and packaged," concluded Dr. Tagliaferri.
We anticipate starting the Phase 1 study in Q1, 2011 and beginning the Phase 3A pivotal trial in Q2, 2011.
"We are excited to move Menerba forward in the path to commercialization. Menerba is an important new treatment approach for millions of women suffering from menopausal hot flashes", said Isaac Cohen, O.M.D., Chairman and CEO of Bionovo. "The discussion with the FDA was also fruitful concerning future potential labeling of Menerba. Bionovo provided additional data to support our claim that Menerba is not an estrogen and not a SERM. The FDA acknowledged that Menerba is a selective estrogen receptor beta agonist. Granted we continue to show no safety concerns after the Phase 3 trials, Menerba will provide a safer alternative to current hormone therapy."
About Menerba
Menerba is an oral botanical drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. 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.
About Bionovo, Inc.
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 and is traded on the NASDAQ Capital Market under the symbol, "BNVI". 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.
