EMERYVILLE, Calif., Nov. 20 Bionovo, Inc.(Nasdaq: BNVI) announced the company will present results from the Phase 1Bclinical trial of their lead drug candidate for advanced metastatic breastcancer, BZL101, at the Society for Integrative Oncology's Fifth InternationalConference in Atlanta, Georgia. The Company's oral presentation was selectedas a top scoring abstract and will be presented as a part of the Best of theSIO Session on November 20, 2008.
The Phase 1B clinical trial was conducted at seven US clinical sites underthe directorship of Dr. Charles Shapiro, Professor of Medicine and Director ofBreast Oncology at Ohio State University. The primary objective of the studywas to identify the maximum tolerated dose of BZL101 and to determine thesafety and feasibility of the company's novel, oral anticancer therapy. Atotal of 27 women with metastatic breast cancer were enrolled to the Phase 1Btrial. To date, 48 women with advanced breast cancer have been treated withBZL101 in two early phase trials. Results from the Phase 1B trial show thatBZL101 continues to be safe and well-tolerated, with early signs of clinicalefficacy.
Seventeen of the twenty-seven participants in the Phase 1B clinical trialwere evaluable according to the Response Evaluation Criteria in Solid Tumors(RECIST). Of these seventeen evaluable women, six were stable on studymedication for greater than 90 days and three were stable on study medicationfor greater than 180 days. One active patient on the trial has been stablefor 12 months with radiographic evidence of tumor shrinkage.
"We are eager to advance BZL101 to Phase 2 clinical testing as the drugcontinues to have an improved safety profile over more traditionalchemotherapeutic agents, and shows encouraging clinical activity in a cohortof women who have been heavily, but unsuccessfully, pretreated for metastaticbreast cancer," said Dr. Mary Tagliaferri, President and Chief Medical Officerof Bionovo.
Overall compliance with study medication was excellent with 90% ofprescribed doses taken. The most common side effects experienced by women inthe Phase 1B clinical trial were mild diarrhea and nausea.
"We are encouraged by the results of the Company's second Phase 1 trial inwomen with advanced breast cancer," said Isaac Cohen, Chairman and CEO ofBionovo. "There are currently over 160,000 women in the United States livingwith advanced breast cancer who are eagerly awaiting an oral anticancer drugwith minimal side effects and the ability to extend life without profoundlydiminishing their quality of life. We believe BZL101 may be an important newanticancer agent because its biological selectivity allows the drug to killcancer cells without affecting normal cells. This will lead to a dramaticallylower side effect profile."
Phase 2 Clinical Trial
The Phase 2 clinical trial is currently enrolling 80 women diagnosed withadvanced, measurable breast cancer who have received no more than two priorcytotoxic cancer therapies.
The trial is open at the following clinical sites under the directorshipof the listed investigators:
BZL101 is an oral drug designed for the treatment of advanced breastcancer with a novel mechanism of action. BZL101 targets diseased cells whileleaving normal cells healthy and intact. Normal cells depend primarily on thecitric acid cycle (>85%) and very little on glycolysis (<7%) for energyproduction. Cancer cells depend largely on glycolysis (>85%) for energyproduction. BZL101 stops the production cycle of energy in cancer cells byinhibiting glycolysis. This leads to DNA damage and cell death in cancer cellswhile normal cells remain unharmed.
There are currently no effective therapeutic cures for advanced breastcancer and treatment is primarily aimed at palliation of symptoms as well asimproving overall survival. Over 200,000 women in the United States arediagnosed with breast cancer each year and breast cancer is the second leadingcause of cancer death in women. Although survival after breast cancertreatment is improving, there are still over 40,000 deaths per year due to thedisease in the Unites States alone.
Bionovo is a pharmaceutical company focused on the discovery anddevelopment 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 todesign new drugs derived from botanical sources which have novel mechanisms ofaction. Based on the results of early and mid-stage clinical trials, Bionovobelieves they have discovered new classes of drug candidates within their richpipeline with the potential to be leaders in their markets. Bionovo isheadquartered in Emeryville, California and is traded on the NASDAQ CapitalMarket under the symbol, "BNVI". For more information about Bionovo and itsprograms, visit http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to thebusiness of Bionovo, Inc. that can be identified by the use of forward-lookingterminology such as "believes," "expects," or similar expressions. Suchforward-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 orother 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 bematerially different from those described herein as anticipated, believed,estimated or expected. Certain of these risks and uncertainties are or will bedescribed in greater detail in our filings with the Securities and ExchangeCommission, which are available at http://www.sec.gov. Bionovo, Inc. is underno obligation (and expressly disclaims any such obligation) to update or alterits forward-looking statements whether as a result of new information, futureevents or otherwise.Institution Site Principle Investigator 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, California 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
SOURCE Bionovo, Inc.