Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for Metastatic Bre...( EMERYVILLE Calif. A...),Health

EMERYVILLE, Calif., August 4 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced positive results from the Phase 1B clinical trial of Bezielle (formerly BZL101), their lead drug candidate for advanced breast cancer. In the trial, Bezielle showed an excellent safety and tolerability profile, and also showed promising indications of efficacy in a difficult-to-treat population.

The Phase 1B clinical trial was conducted at eight US clinical sites under the directorship of Dr. Charles Shapiro, Professor of Medicine and Director of Breast Oncology at Ohio State University. The primary objective of the study was to identify the maximum tolerated dose of Bezielle and to determine the safety, feasibility and preliminary efficacy of the Company's novel, oral, anticancer therapy. A total of twenty-seven women with metastatic breast cancer were enrolled to the Phase 1B trial.

To date, 48 women with advanced breast cancer have been successfully treated with Bezielle in two early clinical trials. In a previous Phase 1A study, Bezielle demonstrated very limited toxicity with a favorable tolerability profile and encouraging clinical activity among a cohort of patients with metastatic breast cancer who had been heavily pretreated with anticancer therapies. Results from this second Phase 1B study provide further support that Bezielle is safe and well-tolerated, with early signs of clinical efficacy.

Safety Analysis

In comparison to other oral cytotoxic agents, Bezielle was extremely safe and well tolerated. No drug-related deaths or serious adverse events occurred during the study, and 94% of all drug-related adverse events were classified as grade 1 and 2 side effects per the National Cancer Institute Common Terminology Criteria for Adverse Events. The mo
'/>"/>