EMERYVILLE, Calif., Feb. 10, 2011 /PRNewswire/ -- Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today articulated for investors the Company's plan of action for 2011 in the development of MF101 (Menerba™). The company also updated its investor information, available on the company's website.
"Having positive clinical and non-clinical data to date, regulatory clarity on requirements from the FDA and the EMA, we can confidently proceed in advancing Menerba into pivotal clinical testing," commented Dr. Isaac Cohen, chairman and chief executive officer of Bionovo, Inc. "Our recent successful financing was an additional validation for Menerba's future development toward commercialization. I look forward to concentrating on executing the business plan and proving the validity of our novel drug development process."
The Company's announced activities and milestones during 2011, based on current plans and progress, include:Manufacture of drug material at higher potency for clinical and non-clinical testing.
Early first quarter.Conduct a 40 patient, 28-day "tolerability" trial at higher doses planned for later studies.
Late first quarter, early second quarter.Non-clinical study for toxicity in rodents.
Late first quarter, early second quarter.Manufacture of clinical material for Phase 3 study, using FDA-approved commercial process.
Second quarter.Complete contracts, IRB approval and training at U.S. clinical sites for the Phase 3 study.
First and second quarter.Initiate patient recruitment and screening in the Phase 3 study.
End of the second quarter.Initiate dosing in the Phase 3 study.
Early in the third quarter.Data Safety Monitoring Board interim reviews of Phase 3 data.
Five reviews are planned during the course of the Phase 3 study.Completion of recruitment for the Phase 3 study.
Anticipated by the end of the second quarter, 2012.Data available from the Phase 3 study.
Anticipated by the end of the fourth quarter, 2012."While we clearly achieved significant levels of efficacy and safety in our Phase 2 trial, compared with recently approved hormonal treatments for hot flashes, we feel it is important to widen the therapeutic window for Menerba. This will prove useful to treating physicians when Menerba is approved for marketing, and may also allow us to show superiority in efficacy and safety, not just parity," said Dr. Mary Tagliaferri, Bionovo's President and Chief Medical Officer. "After consultation with the FDA, we have developed a rigorous protocol for assuring safety and tolerability at higher doses, while not losing any time in the overall clinical development plan."
"Not included in the specific dates and milestones mentioned above, but certainly part of our focused activity, will be to make definitive progress in partnering Menerba with an appropriate marketing and development partner. That process is underway, but is not predictable as to when it can be concluded," said Tom Chesterman, Bionovo's SVP and CFO.
About MenerbaMenerba 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 StatementsThis 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.|
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