Trial Information

BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer

Chemotherapy induced toxicities are common and serious problems for many patients who
receive treatment for cancer. Chemotherapy induced toxicities can adversely impact the
quality of life and the ability of patients to continue treatment for their cancer. One
such toxicity associated with the use of paclitaxel (Taxol®) is peripheral neurotoxicity.

Paclitaxel is an active drug in the treatment of metastatic breast cancer as first-line
treatment and in patients with recurrent or refractory disease, including patients who have
failed to respond to previous anthracycline therapy. Recent studies with paclitaxel using a
weekly schedule of administration have demonstrated higher tumor response rates and disease
free survival accompanied by a shift in the frequency of certain toxicities, increased dose
intensity and a potential means to improve the treatment schedule of paclitaxel for improved
patient benefit.

Paclitaxel induced neurotoxicity remains an important problem that limits the ability to
improve the schedule of administration of this drug. To date, there is no effective or FDA
approved therapy to prevent the development of or reduce the frequency or severity of
paclitaxel-induced neurotoxicity.

BNP7787 is an investigational new drug that is undergoing development for chemoprotection of
platinum and taxane associated common clinical toxicities, particularly the prevention of
chemotherapy-induced neurotoxicity.

In this Phase 3 clinical trial the safety and effectiveness of BNP7787 in preventing or
mitigating the frequency, severity, worsening of grade, time to onset, duration and
discontinuation of therapy due to paclitaxel-induced neurotoxicity will be assessed in
patients with metastatic breast cancer.