Bionovo, Inc. has announced the company will present results from the Phase 1B clinical trial of their lead drug candidate for advanced metastatic breast cancer, BZL101, at the Society for Integrative Oncology's Fifth International Conference in Atlanta, Georgia.
The Company's oral presentation was selected as a top scoring abstract and will be presented as a part of the Best of the SIO Session on November 20, 2008.
The Phase 1B clinical trial was conducted at seven 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 BZL101 and to determine the safety and feasibility of the company's novel, oral anticancer therapy. A total of 27 women with metastatic breast cancer were enrolled to the Phase 1B trial. To date, 48 women with advanced breast cancer have been treated with BZL101 in two early phase trials. Results from the Phase 1B trial show that BZL101 continues to be safe and well-tolerated, with early signs of clinical efficacy.
Seventeen 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 seventeen evaluable women, six were stable on study medication for greater than 90 days and three were stable on study medication for greater than 180 days. One active patient on the trial has been stable for 12 months with radiographic evidence of tumor shrinkage.
"We are eager to advance BZL101 to Phase 2 clinical testing as the drug continues to have an improved safety profile over more traditional chemotherapeutic agents, and shows encouraging clinical activity in a cohort of women who have been heavily, but unsuccessfully, pretreated for metastatic breast cancer," said Dr. Mary Tagliaferri, President and Chief Medical Officer of Bionovo.
Overall compliance with study medication was excellent with 90% of prescribed doses taken. The most common side effects experienced by women in the Phase 1B clinical trial were mild diarrhea and nausea.
"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. "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 their 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 trial is open at the following clinical sites under the directorship of the listed investigators:
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 BZL101
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.