Early trial shows botanical for advanced breast cancer ready for next step.
An oral drug derived from a herb has shown some promise in treating advanced-stage breast cancer in early clinical trials designed to test the best dose and safety. Scutellaria barbata, a herb common in parts of Asia, is used in traditional Chinese medicine to treat bacterial infections, hepatitis and tumors.
Bezielle (BZL100) is an oral extract of the herb, says Mary Tagliaferri, MD, the chief medical officer and president of Bionovo, the biotechnology company developing bezielle. In contrast to typical drug development, which separates an extract into its various components, bezielle is being tested with the hypothesis that the combination of components it contains would be more effective.
“Bezielle induces strong oxidative stress in cancer cells leading to severe DNA damage,” she says, adding that normal cells remain unharmed. Ultimately, the cancer cells cannot repair the resulting DNA damage done by the drug, says Tagliaferri.
The first phase 1 trial of bezielle shows promising signs of efficacy and indicated the drug is well tolerated and safe for clinical use. The 21 women with advanced breast cancer who took the drug began with an expected average life expectancy of 90 to 120 days. At the end of the trial, 16 patients were evaluated and the average expected survival was 328 days. The follow-up clinical study included 27 women with late-stage cancer who, on average, had tried six prior therapies since diagnosis.
In addition to other signs of positive response, six of the 27 women showed stable disease, three of whom remained stable for 1,130, 836 and 594 days, respectively. Side effects included gastrointestinal events, such as diarrhea and nausea, and fatigue.
A phase 2 trial of bezielle for metastatic breast cancer will be conducted at 16 clinical centers throughout the United States under the direction of Banu Arun, MD, at M.D. Anderson Cancer Center in Houston, and Alejandra Perez, MD, at the Memorial Cancer Institute in Hollywood, Fl.
“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 quality of life,” says Tagliaferri.