Peregrine Pharmaceuticals, Inc. has announced the initiation of an investigator-sponsored trial (IST) for patients with HER2-negative metastatic breast cancer, which accounts for 75% of metastatic breast cancers. This open-label Phase I trial will treat patients with Peregrine's investigational monoclonal antibody bavituximab in combination with the chemotherapy agent paclitaxel.
"Bavituximab combined with chemotherapeutic agents has shown promising anti-tumor activity in two Phase II breast cancer clinical trials and has repeatedly demonstrated synergistic anti-tumor activity in preclinical models," said Alison Stopeck, M.D., lead investigator of this trial and director of the clinical breast cancer program at the Arizona Cancer Center at UMC North. "This safety study will also examine the role of cell-specific microparticles, potentially providing novel insights into biomarkers that may correlate with a patient's response to therapy and ultimate prognosis."
Currently, Peregrine's bavituximab is being evaluated in randomized Phase II trials in front-line non-small cell lung cancer (NSCLC), second-line NSCLC, pancreatic cancer, and HCV. Peregrine's first IST, a Phase I/II trial in hepatocellular carcinoma, was initiated last month and additional studies are being planned.
"Our two signal-seeking Phase II breast cancer trials combining bavituximab with taxane-based chemotherapy regimens showed promising tumor response and progression-free survival," said Joseph S. Shan, vice president, clinical and regulatory affairs at Peregrine Pharmaceuticals. "We are delighted to support Dr. Stopeck and her team as they elucidate the potential mechanisms behind the enhanced anti-tumor activity."