Canadian biotechnology firm Angiochem has started a Phase II clinical trial of ANG1005, a novel paclitaxel-peptide drug conjugate, for the treatment of patients with HER2+ breast cancer.

The trial is designed to assess the anti-tumour activity of ANG1005 as a new approach for treating HER2+ breast cancer patients with progressive or recurrent brain metastases.

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The Phase II clinical trial follows three separate, previously completed, clinical studies of ANG1005 in patients with several solid tumour cancers including a Phase II clinical trial in HER2+ and HER2- breast cancer patients with brain metastasis.

Promising signs of anti-tumour activity were observed in the Phase II trial in HER2+ and HER2- breast cancer patients with brain metastasis supporting the company’s decision to advance the ANG1005 clinical development programme.

Angiochem CEO Jean-Paul Castaigne said the company is happy to advance ANG1005 into further clinical development for HER2+ breast cancer.

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"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," Castaigne said.

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"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."

Around 40 HER2+ breast cancer patients with progressive or recurrent brain metastases will be enrolled in the trial at about ten US clinical sites.

The trial’s endpoints include objective response rate, progression-free survival, overall survival and duration of response, in addition to safety and tolerability.

ANG1005 is a new 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.

The product has demonstrated tolerability similar to paclitaxel and indications of activity in over 200 patients in three clinical studies including two phase I trials, and a Phase II study for which the intent-to-treat (ITT) analysis showed encouraging signs of anti-tumour activity.

Currently, a multi-study Phase II clinical programme is being carried out to further confirm the clinical activity of ANG1005 observed in these earlier studies, including a Phase II clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma and a Phase II trial in HER2+ breast cancer patients.