Results from Bionovo's phase 1B clinical trial of Bezielle published

Jan 17 2010

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%.

A link to the full text of the article is available at:

http://bionovo.com/investors/publications

"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.