EMERYVILLE, Calif., June 5 /PRNewswire-FirstCall/ -- Bionovo Inc. (Nasdaq: BNVI) today announced that it has developed a novel analytical 2-dimensional liquid chromatography mass spectrometry-based (LC/LC-MS/MS) multiplexing platform that allows for the rapid, specific, sensitive automated quantification of the active pharmaceutical compounds of MF101, the company's most advanced drug candidate. The novel quantification has been initially developed for, MF101, which is botanically derived, and has shown positive Phase 2 results for the treatment of hot flashes associated with menopause. The assay was validated in multiple matrices ranging from MF101 extracts for production quality control to plasma in pharmacokinetic and safety trials.
"The development of botanical drugs is far more challenging than a single molecule drug, since these are complex mixtures containing a number of bioactive compounds," said the lead author, Dr. Yan Ling Zhang, Bionovo's Director, Analytical Chemistry. "Our assay is capable of sensitively and specifically quantifying all active MF101 compounds in one short analytical run, and allows us to prove the exquisite precision and consistency of our manufacturing process. This is a tremendous advantage over conventional assays that usually only measure single compounds."
"The availability of this robust high-throughput assay is a key to the fast and successful development of MF101," said Dr. Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "Having the tool to quantify multiple actives solves important questions for manufacturing controls, dose assessment and safety measures. This analytical platform technology is critical to move MF101 quickly through the regulatory process."
MF101 is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to those 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 estrogen receptor alpha (ER-a) activation and that estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. Bionovo recognized the opportunity to commercialize a product that would be equally effective, with an improved safety profile to hormone therapy. The drug candidate has been evaluated by an independent Data and Safety Monitoring Board and has passed through a standard two-round examination for safety.
Bionovo 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.