Bionovo's BZL101 shows anti-tumor activity in phase 1 trial

By Angela McDaniels

Seattle, Dec. 8 - Bionovo Inc. said results from a phase 1 clinical trial of BZL101 in patients with refractory metastatic breast cancer showed that BZL101 has a favorable tolerability profile and demonstrates evidence of clinical activity.

Sixteen patients were evaluable for response. Four had stable disease for more than 90 days and three had stable disease for over 180 days. Five patients had objective tumor regression, the company said.

The data was presented at the 28th Annual San Antonio Breast Cancer Symposium in San Antonio.

Primary endpoints of the open-label trial included safety and toxicity and tumor response. Patients were treated with up to 12 gm in 350 ml solution per day of BZL101 until disease progression, toxicity or personal preference to discontinue treatment.

Patients had failed an average of 3.9 prior treatment regimens for their advanced stage of the disease.

The study was conducted by investigators at the Cancer Research Network in Plantation, Fla., Memorial Cancer Institute in Hollywood, Fla., the University of California, San Francisco, and UT Southwestern Medical Center at Dallas, in collaboration with scientists at Bionovo.

"Based on the promising data from our preclinical and phase 1 clinical trial of BZL101, we are excited to initiate the phase 2 program and hope to do so quickly," said Isaac Cohen, president and chief executive officer, in a company press release.

"I believe this trial's results validate our unique approach to rapid drug development from bench to candidate selection to clinical trial design."

BZL101 is an oral drug candidate specifically targets only malignant cells, leaving the normal cells intact and functioning. It is a standardized aqueous extract from herb scutellaria barbata d. don of the lamiaceae family, the company said.

Bionovo is a drug development company based in Emeryville, Calif., that discovers pharmaceutical agents for the treatment of cancer and women's health.

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