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Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer

EMERYVILLE, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) announced today that its drug candidate for metastatic breast cancer, BZL101, will advance to Phase 2 clinical testing after the successful completion of a second Phase 1 clinical trial.

The Phase 1B clinical trial was conducted to identify the maximum tolerated dose of BZL101 and to determine the safety and feasibility of the company's novel, oral, anticancer treatment. A total of 27 women with metastatic breast cancer were enrolled to this Phase 1B trial. A total of 48 women with advanced breast cancer have been treated with BZL101 in all clinical trials to date. Results from the Phase 1B show Bionovo's lead drug candidate for advanced breast cancer continues to be safe and well-tolerated, with early signs of clinical efficacy. The company will present the findings from the Phase 1B in an oral presentation of the best scoring abstracts at the Society of Integrative Oncology's Fifth International Conference on November 20, 2008 in Atlanta, Georgia.

"We are encouraged by the results of the Company's second Phase 1 trial in women with advanced breast cancer," said Isaac Cohen, President and CEO, Bionovo. "There are currently over 160,000 women in the United States living with advanced breast cancer who are eagerly awaiting an oral anticancer drug with minimal side effects and the ability to extend life without profoundly diminishing quality of life. We believe BZL101 may be an important new anticancer agent because its biological selectivity allows the drug to kill cancer cells without affecting normal cells. This will lead to a dramatically lower side effect profile."

Phase 2 Clinical Trial

The Phase 2 clinical trial is currently enrolling 80 women diagnosed with advanced, measurable breast cancer who have received no more than two prior cytotoxic cancer therapies.

The Principle Investigator of the trial is Dr. Charles Shapiro, Director of Breast Oncology at Ohio State University.

The trial will be open at the following clinical sites under the directorship of the listed investigators:

Institution Site Principle Investigator

Breastlink Medical Group, Long Beach,

California Dr. Bichlien Nguyen

California Cancer Care Inc.,

Greenbrae/San Mateo, California Dr. Peter Eisenberg

Columbia Presbyterian Medical Center,

New York, New York Dr. Dawn Hershman

Comprehensive Cancer Center at Desert

Regional Medical Center, Palm Springs,

California Dr. Gail Leichman

Duke University, Durham, North Carolina Dr. Gretchen Kimmick

Lynn Regional Cancer Center, Boca Raton,

Florida Dr. Reshma Mahtani

MD Anderson, Houston, Texas Dr. Banu Arun

Memorial Cancer Institute, Hollywood,

Florida Dr. Alejandra Perez

Montefiore Medical Center, Bronx,

New York Dr. Tianhong Li

Ohio State University, Columbus, Ohio Dr. Ewa Mrozek

St. Vincent's Medical Center, New York,

New York Dr. Paula Klein

University of California, San Francisco Dr. Hope Rugo

University of Chicago, Chicago, Illinois Dr. Gini Fleming

University of Miami, Miami, Florida Dr. Alberto Montero

University of Pittsburg Magee Women's

Hospital, Pittsburg, Pennsylvania Dr. Adam Brufsky

University of Southern California,

Los Angeles, California Dr. Agustin Garcia

University of Texas, Southwestern,

Dallas, Texas Dr. Jenny Li


BZL101 is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. BZL101 targets diseased 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. Cancer cells depend largely on glycolysis (>85%) for energy production. BZL101 stops the production cycle of energy in cancer cells by inhibiting glycolysis. This leads to DNA damage and cell death in cancer cells while normal cells remain unharmed.

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 in the United States are diagnosed with breast cancer each year and breast cancer is the second leading cause of cancer death in women. Although survival after breast cancer treatment is improving, there are still over 40,000 deaths per year due to the disease in the Unites States alone.

Bionovo, Inc.

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

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 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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