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AngioChem Presents Positive Data On ANG1005 In Brain Mets, Launches Phase 2, Gets Orphan Drug/Fast Track



5/30/2014 10:09:58 AM

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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 presentation of data for its lead drug candidate, ANG1005, a novel paclitaxel-peptide drug conjugate, at the American Society of Clinical Oncology 50th Annual Meeting in Chicago, IL. Phase 1 and Phase 2 clinical studies demonstrated promising signs of both CNS and peripheral anti-tumor activity of ANG1005 in patients with brain metastases including breast cancer patients. Based on these data, Angiochem also announced today that the company has initiated a Phase 2b clinical trial with ANG1005 designed to confirm this anti-tumor activity as a potential new approach to treating HER2+ breast cancer.

“The data being presented on our lead product candidate, ANG1005, underscores its potential utility in treating brain and peripheral metastases from breast cancer and other solid tumors,” said Jean Paul Castaigne, M.D., President and CEO of Angiochem. “Effective management of patients with brain metastases continues to be a major clinical challenge. By actively penetrating the blood-brain barrier and cancer cells through LRP-1 receptor, ANG1005 elicits both CNS and peripheral tumor responses and provides a potential new treatment option for this difficult to treat patient population.” The data to be presented at ASCO includes results from a Phase 1 and initial Phase 2 clinical studies of ANG1005 in HER2+ positive and HER2-negative breast cancer patients and solid tumors with brain metastasis in which promising signs of anti-tumor activity were observed both in CNS and at the periphery. These studies support the advancement of the newly-initiated comprehensive Phase 2 clinical study for ANG1005 in HER2+ breast cancer patients with brain metastases.

ANG1005 represents a first-in-class oncology product that leverages the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. In addition to the newly-initiated comprehensive Phase 2 clinical study in patients with progressive or recurrent brain metastases from HER2+ breast cancer, ANG1005 is also being evaluated in an ongoing Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma.

In a poster presentation entitled “Evaluation of CNS and peripheral antitumor activity of ANG1005 in patients with brain metastases from breast tumors and other advanced solid tumors,” Nancy U. Lin, M.D., Clinical Director Breast Oncology at the Dana Faber Cancer Institute will present Phase 1 and Phase 2 clinical data which demonstrated the anti-tumor activity of ANG1005 on CNS tumors and peripheral metastasis, providing additional patient benefit.

• In a Phase 1 dose escalating (30 to 700 mg/m2) clinical study of ANG1005 in solid tumors with progressive brain metastases 21 patients dosed with ANG1005 at = 420 mg/m2 were evaluated for response including overall tumor response (CNS and peripheral).
o CNS: Four (22%) achieved partial responses (PR) and ten (56%) achieved stable disease
o Peripheral: Four (25%) achieved partial responses and 7 (44%) achieved stable disease
• In a Phase 2 open-label, single arms study with two cohorts (HER2+ and HER2-) breast cancer patients with brain metastases 61 and 32 patients were evaluated for CNS and peripheral tumor response per RECIST criteria at the dose of ANG1005 at 550 mg/m2 or 650 mg/m2
o CNS: 15 (25%) achieved partial responses and 34 (56%) achieved stable disease
o Peripheral: 8 (25%) achieved partial responses and 16 (50%) achieved stable disease
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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