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.

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.

"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.

"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.