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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, Florid
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