Angiochem Intiates Phase 2 Clinical Study for Lead Drug ANG1005 in Breast Cancer with Brain Metastases

Novel Peptide Drug Conjugate to Target HER2+ Breast Cancer Patients with Progressive or Recurrent Brain Metastases, a Cancer with High Unmet Medical Need  

Montreal, Canada, May 30, 2014 – 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. 

About ANG1005

ANG1005 is a novel paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. ANG1005 has been studied in over 200 patients in three clinical studies; two phase 1 studies where the product has shown tolerability similar to paclitaxel and indications of activity, and a Phase 2 study for which the intent-to-treat (ITT) analysis demonstrated encouraging signs of anti-tumor activity and was reported at the 2013 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference.  A multi-study Phase 2 clinical program is underway to further confirm the clinical activity of ANG1005 observed in these earlier studies, including a Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma and a Phase 2 clinical study in in HER2+ breast cancer patients. 

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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