Bionovo, Inc.'s Phase 1/2 Clinical Trial Protocol For Metastatic Breast Cancer Accepted By FDA

EMERYVILLE, Calif., Oct. 31 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has accepted Bionovo, Inc.'s protocol to begin its multi-center Phase 1/2 clinical trial for BZL101, the company's lead candidate for metastatic breast cancer. The study is designed to determine the maximum tolerated dose and to evaluate the safety and efficacy of BZL101. Recruitment and testing will take place at 10 clinical sites in the U.S. The company expects to begin patient enrollment early in the first quarter of 2007. Dr. Debu Tripathy, Director of the Komen/UT Southwestern Breast Cancer Research Program at the University of Texas Southwestern Medical Center in Dallas will serve as the overall Principal Investigator. Dr. Tripathy has an extensive background in pre-clinical and clinical trials and was one of the lead investigators on the pivotal Herceptin trials sponsored by Genentech.

The primary endpoint measured in the Phase 1/2 open-label, non-randomized, dose-escalation trial will be response to therapy evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST). Secondary measures of efficacy will include duration of overall objective response, progression-free survival, overall survival, and patient-reported quality of life.

"This trial and the quality of experts involved, demonstrate the recognized need for an innovative and rational approach to breast cancer therapy," said Dr. Isaac Cohen, President and CEO of Bionovo. "BZL101 represents how Bionovo has been able to apply a novel process to identify a compound with a known mechanism of action, which induces cancer cell death, and also exhibits a favorable safety profile."

BZL101 has been shown in both pre-clinical and Phase 1 studies to be selective to cancer cells while leaving normal cells unaffected. BZL101 is an oral drug that induces apoptosis through mitochondrial transmembrane potentiation. Specifically, it translocates the apoptosis-inducing factor 1 (AIF1) protein into the nucleus of the cell causing chromatin condensation and DNA degradation that leads to cancer cell death. When tested on five breast cancer cell lines, BZL101 has been shown to inhibit greater than 50% growth on a panel of lung, prostate and pancreatic cell lines while not causing significant growth inhibition or toxic effects on normal human mammary cells. As well, BZL101 has shown activity in a human breast cancer mouse xenograft model and has been piloted for safety in a Phase 1 human trial. The results from the Phase 1 clinical trial showed BZL101 was safe and had a favorable toxicity profile. It also demonstrated encouraging clinical activity in a heavily pretreated population of women with metastatic breast cancer.

There are currently no effective therapeutic cures for advanced breast cancer and treatment is primarily aimed at palliation of symptoms as well as improving overall survival. Over 200,000 women are diagnosed with breast cancer each year and breast cancer is the second leading cause of cancer death. Although survival after breast cancer treatment is improving, there are still over 40,000 deaths per year due to the disease. The annual market for drugs targeted at this disease is estimated at $7 billion.

About 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 two drugs in clinical testing: MF101 in Phase 2 for quality of life conditions associated with menopause and BZL101 in Phase 1/2 for the treatment of advanced breast cancer. The company has an additional pipeline of drugs in development for breast cancer, pancreatic cancer and other menopausal symptoms with a total of 5 candidates expected to be in clinical trials by the end of 2007. 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 Medical Center in Dallas, TX. 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 SEC), which are available at 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: Jim Stapleton, Chief Financial Officer of Bionovo, Inc.,+1-510-601-2000, or jim@bionovo.com; or Jennifer Larson of Labfive,+1-415-409-2729, or jlarson@labfive.com, for Bionovo, Inc.; or investors,Antima "Taz" Sadhukhan of Investor Relations Group, +1-212-825-3210, forBionovo, Inc.

Web site: http://www.bionovo.com/