Bionovo’s Phase 1B Clinical Trial Of Bezielle Shows Positive Results

Bionovo has reported positive results from the phase 1B clinical trial of Bezielle (formerly BZL101), their lead drug candidate for advanced breast cancer.

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 this novel, oral, anticancer therapy. A total of 27 women with metastatic breast cancer were enrolled to the phase 1B trial.

The company said that, so far, 48 women with advanced breast cancer have been successfully treated with Bezielle in two early clinical trials.

Results from this second phase 1B study showed that Bezielle is safe and well-tolerated, with early signs of clinical efficacy.

Isaac Cohen, chairman and CEO of Bionovo, said: We are encouraged by the results of the company’s second Phase 1 trial in women with advanced breast cancer. Despite improvements in currently available breast cancer therapies, the five-year survival rate of women who develop metastatic disease is still only 27%. Many of these therapies cause women with advanced breast cancer additional discomfort through severe side effects resulting in a poor quality of life at the end of life.

We are aiming to improve the extract formulation so we can further improve on the gastrointestinal symptoms associated with Bezielle treatment. We believe Bezielle may be an important new anticancer agent because its biological selectivity allows it to kill cancer cells without affecting normal cells. This also leads to a dramatically lower side effect profile, he added.