SOURCE: Angiochem

Angiochem

June 23, 2016 07:00 ET

Angiochem Announces Successful End-of-Phase 2 Meeting With FDA for ANG1005

MONTREAL, QC--(Marketwired - June 23, 2016) - Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, today 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 demonstrated clinical benefit, both intracranially and extracranially in pretreated BCBM patients with LC in the company's Phase 2 trial.

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.

About Angiochem

Angiochem is a clinical-stage biotechnology company discovering and developing new breakthrough peptide drug conjugates that leverage the LRP-1 mediated pathway to cross the BBB to treat neurological diseases. These new compounds have the potential to address significant medical needs, many of which are insurmountable due to the fundamental physiological challenge posed by the BBB.

Angiochem is developing a focused product pipeline, including small molecules and biologics, for the potential treatment of a wide range of CNS diseases, including primary brain cancer, brain metastases, lysosomal storage diseases and pain. Founded in 2003, Angiochem maintains headquarters in Montreal, Canada. For additional information about the Company, please visit http://www.angiochem.com.

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