Bionovo Trial Protocol Accepted By FDA
Posted on: Wednesday, 1 November 2006, 09:00 CST
The FDA has accepted Bionovo's protocol of its phase I/II clinical trial for BZL101, a treatment for metastatic breast cancer.
The study is designed to determine the maximum tolerated dose and to evaluate the safety and efficacy of BZL101. The company expects to begin patient enrollment early in the first quarter of 2007.
The primary endpoint measured in the trial will be response to therapy. Secondary measures of efficacy will include duration of overall objective response, progression-free survival, overall survival, and patient-reported quality of life.
BZL101 has been shown in both preclinical and phase I studies to be selective to cancer cells while leaving normal cells unaffected. When tested on five breast cancer cell lines, BZL101 has been shown to inhibit greater than 50% growth on a panel of lung, prostate and pancreatic cell lines while not causing significant growth inhibition or toxic effects on normal human mammary cells.
Additionally, BZL101 has shown activity in a human breast cancer mouse xenograft model and has been piloted for safety in a phase I human trial. The results from the phase I clinical trial showed BZL101 was safe and had a favorable toxicity profile. It also demonstrated encouraging clinical activity in a heavily pretreated population of women with metastatic breast cancer.
Source: Datamonitor
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