EMERYVILLE, Calif., June 5 /PRNewswire-FirstCall/ -- Bionovo, Inc. released new data on the Company’s lead drug candidate, MF101, for the treatment of vasomotor symptoms, such as hot flashes and night sweats, associated with menopause at the American Society for Mass Spectroscopy 54th Annual Meeting in Seattle.
Bionovo researchers hypothesize that estrogen receptor beta (ERBeta)- selective estrogens may be a safer alternative for women to treat menopausal symptoms, because they do not cause proliferation of breast cancer or uterine cells like estrogens used in current hormone replacement therapy (HRT) regimens. Bionovo has isolated several key compounds from MF101 that show ERBeta-selectivity in vitro and in animal models. Under the direction of Yan Ling Zhang, Ph.D., Company researchers presented at the Annual Meeting, specific, sensitive, fully validated, automated high-throughput liquid chromatograph-tandem mass spectrometry assays for those compounds. The studies also demonstrated that the ERBeta-selective compounds were absorbed in significant amounts by post-menopausal women after oral administration of MF101.
“The availability of robust assays that allow for the highly sensitive and specific quantification of ERBeta-selective compounds in complex biological matrices is a critical achievement. It not only represents a milestone for the clinical development of MF101 but will also allow for the systematic pre- clinical and clinical development of the isolated active compounds,” said Dr. Isaac Cohen, Bionovo’s President and Chief Executive Officer. “Bionovo is committed to discovering and developing safe, novel therapies to treat the symptoms of menopause, a condition that is under-treated because of the high risk of life-threatening side effects. The development of novel cutting-edge analytical assays has brought us a step closer to FDA approval of MF101.”
About MF101
MF101, an ERBeta-selective agonist, is designed for the treatment of vasomotor symptoms such as hot flashes and night sweats in menopausal women. In animal studies the compound has been shown to prevent tumor formation in the breast or uterus, suggesting that MF101 will not increase the risk of either breast or uterine cancer. In Phase 1 clinical testing of MF101, the drug was found to be safe, well tolerated and taken with high compliance. A multicenter Phase 2 double-blind, placebo-controlled, randomized clinical trial of MF101 is currently underway at 6 academic centers throughout the United States.
Bionovo, Inc.
Bionovo is a drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women’s health. The company has one drug in Phase 2 clinical testing to treat conditions associated with menopause and a second drug, BZL101, for breast cancer, will enter Phase 2 clinical testing later this year. The company is developing its products in close collaboration with leading U.S. academic research centers including the University of California, San Francisco; University of Colorado Health Sciences Center; University of California, Berkeley; and the University of Texas, Southwestern. For further information please 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.
Bionovo, Inc.
CONTACT: Jim Stapleton of Chief Financial Officer, Bionovo, Inc.,+1-510-601-2000, jim@bionovo.com; or Investors: Antima “Taz” Sadhukhan orMedia: Janet Vasquez, both of Investor Relations Group, +1-212-825-3210
Web site: http://www.bionovo.com/
