Peregrine Pharmaceuticals, Inc. has announced the initiation of an investigator-sponsored trial (IST) for patients with castration-resistant prostate cancer (CRPC). Peregrine's fourth IST, this Phase I/II trial will treat up to 31 second-line CRPC patients with Peregrine's investigational monoclonal antibody bavituximab in combination with the chemotherapeutic agent cabazitaxel.
"Once prostate cancer patients have failed treatment with docetaxel-based chemotherapy, options are unfortunately limited," said Michael Lilly, M.D., principal investigator and professor of clinical medicine, Division of Hematology-Oncology at The University of California, Irvine.
Lilly continued, "As the first approved agent for second-line CRPC, cabazitaxel provides modest survival benefits, but there remains significant room for improvement in the treatment of this patient population. We look forward to evaluating whether the combination of bavituximab and cabazitaxel can extend progression-free survival in these patients."
In multiple clinical trials, bavituximab combined with taxane-based chemotherapies has demonstrated promising signs of anti-tumor activity and a positive safety profile. In a preclinical model of CRPC, a bavituximab-like antibody combined with taxane-based chemotherapy yielded potent anti-tumor effects, reducing primary tumor burden by 95% and completely inhibited metastatic development.
Bavituximab is also being evaluated in randomized Phase II trials in non-small cell lung cancer (NSCLC), pancreatic cancer, and hepatitis C virus (HCV) infection, as well as multiple ISTs in different oncology indications.