EMERYVILLE, Calif., Jan. 14 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) announced today the publication of their results from its phase 1B clinical trial of Bezielle (BZL101) for metastatic breast cancer. The results of the study are available online in Breast Cancer Research and Treatment and demonstrate that Bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer. Preliminary results from this study were released previously by the Company.
The purpose of the phase 1B clinical trial was to identify the maximum tolerated dose of Bezielle and to determine the safety and feasibility of the company's novel, oral, anticancer treatment. A total of 27 women with late stage breast cancer were enrolled to the phase 1B trial. The 27 enrolled women had failed an average of six prior therapies since diagnosis with metastatic breast disease and expected survival pre-trial was 90–120 days. To date, a total of 48 women with advanced breast cancer have been treated with Bezielle in two early phase clinical trials.
Highlights of the Bezielle phase 1B clinical trial are as follows:
- Independent radiology showed 6 patients had stable disease.
- Independent radiology showed 3 patients had evidence of tumor regression consistent with a minimal tumor response (>0% and <30%).
- Three patients had stable disease for >120 days.
- Four patients discontinued Bezielle with stable disease; one was on Bezielle for 449 days and had evidence of minimal tumor regression and continues to be stable for 700+ days. A second patient remained stable for 836 days and a third patient remained stable for 594 days.
- There were no deaths that were attributed to Bezielle therapy.
- The most common side effects associated with Bezielle therapy were minor and gastrointestinal in nature.
- The maximum tolerated dose was four times the dose evaluated in the phase 1a study.
- Median treatment compliance was 92%.
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"We are encouraged by the results of the Company's second phase 1 trial in women with advanced breast cancer and feel the oncology community is equally enthusiastic about Bezielle as our manuscript was accepted by the most widely read breast cancer specific peer reviewed journal in two days," said Mary Tagliaferri, President and Chief Medical Officer of 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 that can extend life without profoundly diminishing quality of life. We believe Bezielle will be an important new anticancer agent because its biological selectivity allows the drug to kill cancer cells without affecting normal cells resulting in dramatically fewer side effects."
"In the age of sequential monotherapy as the treatment approach for women with metastatic breast cancer, Bezielle is one of the most exciting new therapies under investigation today," said Banu Arun, M.D., Department of Breast Medical Oncology, Division of Cancer Medicine, University of Texas, M.D. Anderson Cancer Center, Houston, Texas. "At our center, where over 3,000 women are newly diagnosed with breast cancer each year, there is great patient demand for oral drugs with minimal toxicities for the treatment of any stage breast cancer. Bezielle is the exact type of drug our patients are seeking and the favorable clinical results in Bionovo's two early stage clinical trials among a heavily pretreated patient population are extremely encouraging."
"While safety and maximum tolerability were the primary endpoints of this second phase 1 trial, Bezielle demonstrated promising clinical efficacy in both phase 1 trials affording some women with long periods of stable disease without dramatically altering their day to day quality of life, which is a significant advancement," said Alejandra Perez, M.D., Director of the Breast Cancer Center at the Memorial Regional Hospital Cancer Institute, Hollywood, Florida.
A phase 2 trial of Bezielle for metastatic breast cancer under the directorship of Dr. Banu Arun at the University of Texas, M. D. Anderson Cancer Center and Dr. Alejandra Perez at the Memorial Regional Hospital will commence once funding is secured. The phase 2 study will be conducted at 16 clinical centers in the United States and will enroll 80 women with metastatic breast cancer.
Bezielle is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. Bezielle 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. Bezielle 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 largely 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 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.