Bionovo Announces Positive Developments in On-going Phase 1/2 Cancer Drug TrialPatients Showing Excellent Tolerability at Higher Doses in Dose Escalation
EMERYVILLE, Calif., February 20, 2008 /PRNewswire-FirstCall/ -- Bionovo, Inc. today announced that the higher doses of its innovative breast cancer drug candidate, BZL101 were well tolerated. As a result, the company will be extending the dose escalation portion of the study longer than previously communicated.
"We had expected to reach the maximum tolerated dose earlier, and then transition to the full Phase 2 component of the trial with that dose. Instead, we have seen very favorable tolerability data at the higher doses, and we are continuing to escalate the dose," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "As a result of this positive news, we will continue the dose escalation, so long as we continue to see favorable tolerability and safety, after which we will transition to the full Phase 2 study component."
Separately, Isaac Cohen, O.M.D., Bionovo's Chairman and CEO, stated, "We also completed further laboratory analyses on the mechanism of action and chemical characteristics of BZL101, which are striking and result in highly selective cancer cell killing. We expect to be presenting this data at key scientific conferences later this year, along with any available efficacy information."
BZL101 is an oral drug designed for the treatment of advanced breast cancer and pancreatic cancer with a novel mechanism of action. BZL101 targets cancer cells while leaving normal cells healthy and intact. Normal cells depend primarily on the citric acid cycle (>85%) and very little on glycolysis (<7%) for energy production. In contrast, cancer cells depend largely on glycolysis (>85%) for energy production. BZL101 leads to energy collapse in cancer cells by inhibiting glycolysis. This leads to DNA damage and cell death in cancer cells while normal cells remain unharmed.
BZL101 has completed early stage clinical testing and data from the Phase 1 trial of BZL101 conducted at the University of California, San Francisco and the Cancer Research Network in Plantation, Florida indicate that BZL101 has a favorable tolerability profile and demonstrates encouraging clinical activity in a heavily pretreated population. BZL101 is currently undergoing Phase 1/2 clinical testing for late stage metastatic breast cancer. Visit http://www.bzl101.com to find out more about BZL101.
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.
CONTACT: T.C. Chesterman, Chief Financial Officer of Bionovo, Inc.,+1-510-420-4189
Web site: http://www.bionovo.com/
Ticker Symbol: (NASDAQ-NMS:BNVI)
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Posted: February 2008