Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for ANG1005. As a result, the company is in final preparation stages to commence its Phase 3 trial to support a New Drug Application (NDA) for ANG1005 in patients with leptomeningeal carcinomatosis (LC) from breast cancer.
“We are very pleased with our recent positive interaction with the FDA” said John Huss, Executive Chairman of Angiochem. “Based on the constructive guidance received from our discussions with the FDA, we believe our clinical development and registration strategy for ANG1005 will support an NDA submission. We are excited to start Phase 3, and bring ANG1005 treatment to an expanded number of patients with few alternative treatment options.”
The trial design for the single pivotal study is a randomized two-arm superiority trial in breast cancer patients with recurrent brain metastases (BCBM patients) and LC. The primary efficacy endpoint of the study is a significant improvement in overall survival with ANG1005 compared to treatment with Physicians’ Best Choice.
ANG1005 is a peptide-drug conjugate containing paclitaxel covalently linked to a peptide (Angiopep-2) designed to cross the blood-brain barrier (BBB) and blood cerebrospinal fluid barrier (BCB) via the LRP-1 transport system.
