Angiochem, a clinical stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier (BBB), today announced the initiation of a Phase 2 clinical study with ANG1005, a novel paclitaxel-peptide drug conjugate, in HER2+ breast cancer patients. This study is designed to evaluate the anti-tumor activity of ANG1005 as a new approach to treating HER2+ breast cancer patients with progressive or recurrent brain metastases. This Phase 2 clinical study follows three separate, previously completed, clinical studies of ANG1005 in patients with a variety of solid tumor cancers including a Phase 2 clinical study in HER2+ and HER2- breast cancer patients with brain metastasis in which promising signs of anti-tumor activity were observed supporting the Company's decision to advance the ANG1005 clinical development program.
"We are excited to advance ANG1005 into further clinical development for HER2+ breast cancer," said Jean-Paul Castaigne, MD, CEO of Angiochem. "Progressive or recurrent brain metastases in this patient population continues to be a major clinical challenge and area of significant unmet need for innovative new treatments. In preclinical and early clinical studies, ANG1005 has demonstrated the ability to cross the blood-brain barrier, offering the potential for significant benefit to this patient population with a very challenging cancer."
This Phase 2 clinical study is designed to evaluate the anti-tumor activity of ANG1005 in up to 40 HER2+ breast cancer patients with progressive or recurrent brain metastases at approximately 10 U.S. clinical sites. Study endpoints include objective response rate, progression-free survival, overall survival and duration of response, in addition to safety and tolerability. For more information about the study please refer to www.clinicaltrials.gov.