NewsRx.com
June 12, 2008
Bionovo Inc. announced results from a second ongoing clinical trial of BZL101, an oral drug candidate, in patients with refractory, metastatic breast cancer. The data, which were presented at the American Society of Clinical Oncology 44th Annual Meeting, showed that BZL101, at higher doses, continues to have a favorable safety and tolerability profile and shows ongoing evidence of clinical activity in women with advanced breast cancer.
"We are encouraged by the positive results of this second study which further underscores BZL101's safety at higher doses and highlights its potential as an effective, novel, oral treatment for the more than 45,000 women who are diagnosed with this late stage breast cancer each year," said lead author, Dr. Alejandra Perez, Director of the Breast Cancer Center at the Memorial Regional Hospital Cancer Institute. "While safety and maximum tolerability are the primary endpoints of the trial, BZL101 also showed early clinical efficacy, including one patient who has been stable for 13 months and shows radiographic evidence of tumor shrinkage."
The study is being conducted by investigators at Duke University, Columbia Presbyterian Medical Center, University of Chicago, University of Texas Southwestern Medical Center, Ohio State University, Montefiore Medical Center, Cancer Research Network and Memorial Regional Cancer Institute in collaboration with scientists at Bionovo. The study is a Phase 1/2 trial, and is currently in the Phase 1 Dose Escalation component, and is expected to progress to the Phase 2 component and full recruitment during the third quarter of this year.
"Based on the promising data from the early clinical trials of BZL101, we are excited to transition to our FDA-approved Phase 2 program later this year," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "I believe this trial's results further validate the potential for a novel, oral anticancer drug with a unique mechanism of action that selectively target cancer cells without affecting normal cells as evidenced by our low toxicity and early clinical efficacy. Due to BZL101's favorable results to date, Bionovo will consider studying BZL101 as the first non-hormonal, oral adjuvant for early breast cancer."
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