EMERYVILLE, Calif., August 4, 2009 /PRNewswire-FirstCall via COMTEX/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced positive results from the Phase 1B clinical trial of Bezielle (formerly BZL101), their lead drug candidate for advanced breast cancer. In the trial, Bezielle showed an excellent safety and tolerability profile, and also showed promising indications of efficacy in a difficult-to-treat population.
The Phase 1B clinical trial was conducted at eight US clinical sites under the directorship of Dr. Charles Shapiro, Professor of Medicine and Director of Breast Oncology at Ohio State University. The primary objective of the study was to identify the maximum tolerated dose of Bezielle and to determine the safety, feasibility and preliminary efficacy of the Company's novel, oral, anticancer therapy. A total of twenty-seven women with metastatic breast cancer were enrolled to the Phase 1B trial.
To date, 48 women with advanced breast cancer have been successfully treated with Bezielle in two early clinical trials. In a previous Phase 1A study, Bezielle demonstrated very limited toxicity with a favorable tolerability profile and encouraging clinical activity among a cohort of patients with metastatic breast cancer who had been heavily pretreated with anticancer therapies. Results from this second Phase 1B study provide further support that Bezielle is safe and well-tolerated, with early signs of clinical efficacy.
In comparison to other oral cytotoxic agents, Bezielle was extremely safe and well tolerated. No drug-related deaths or serious adverse events occurred during the study, and 94% of all drug-related adverse events were classified as grade 1 and 2 side effects per the National Cancer Institute Common Terminology Criteria for Adverse Events. The most common adverse events associated with Bezielle were grade 1 and 2 gastrointestinal side effects, accounting for 56% of all drug-related adverse events.
Sixteen of the twenty-seven participants in the Phase 1B clinical trial were evaluable according to the Response Evaluation Criteria in Solid Tumors (RECIST). Of these sixteen evaluable women, five (31%) were stable on Bezielle for greater than 90 days and two (13%) were stable on Bezielle for greater than 180 days. Three patients (19%) on Bezielle had objective tumor regression, as evaluated by an independent radiology review.
Four patients discontinued from the study with stable disease, and of these four patients, one patient had objective tumor regression during 449 days of Bezielle treatment and continues to be stable off of study medication for a total of 600 days. A second patient who discontinued Bezielle treatment with stable disease continues to be stable for 832 days and has not started any new anticancer treatment. A third patient who discontinued with stable disease was stable for 591 days before evidence of progression. Further analyses on overall survival and progression-free survival will be performed.
Dose Escalation and Compliance
Overall compliance with study medication was excellent with 90% of prescribed doses taken. A maximum tolerated dose, as defined in study protocol, was never established despite dose escalation reaching a dose that was four times (40g/day) the previously evaluated Phase 1A dose.
"We are eager to advance Bezielle to Phase 2 clinical testing as the drug continues to have an improved safety profile over currently available chemotherapeutic agents, and shows encouraging clinical activity in a cohort of women who have been heavily pretreated for metastatic breast cancer," said Dr. Mary Tagliaferri, President and Chief Medical Officer, Bionovo.
"We are encouraged by the results of the Company's second Phase 1 trial in women with advanced breast cancer," said Isaac Cohen, Chairman and CEO of Bionovo. "Despite improvements in currently available breast cancer therapies, the five-year survival rate of women who develop metastatic disease is still only 27%. Many of these therapies cause women with advanced breast cancer additional discomfort through severe side effects resulting in a poor quality of life at the end of life. 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 that can extend life without profoundly diminishing their quality of life. We are aiming to improve the extract formulation so we can further improve on the gastrointestinal symptoms associated with Bezielle treatment. We believe Bezielle may be an important new anticancer agent because its biological selectivity allows it to kill cancer cells without affecting normal cells. This also leads to a dramatically lower side effect profile."
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 induces greater production of reactive oxygen species in cancer cells. This results in high levels of DNA damage and the hyperactivation of PARP. The resulting depletion of NAD and ATP (PARP substrates), results in the inhibition of glycolysis, energetic collapse, and programmed necrosis.
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 192,000 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.
SOURCE Bionovo, Inc.