Canadian clinical stage biotechnology firm Angiochem has started Phase II clinical trial with a novel paclitaxel-peptide drug conjugate ANG1005 in patients with recurrent high-grade glioma.
The trial is aimed at assessing anti-tumour activity of ANG1005 as a new approach to treating primary brain cancers including recurrent glioblastoma multiforme (GBM) and anaplastic glioma.
Angiochem CEO Jean-Paul Castaigne said: "There is a significant unmet need for innovative new treatments for recurrent gliomas such as GBM, one of the most common and most aggressive forms of primary brain cancer.
"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."
A total of 83 patients with recurrent high-grade glioma will be enrolled in the Phase II clinical trial, which will be carried out at around ten US clinical sites.
Endpoints of the trial include objective response rate, progression-free survival and median overall survival, in addition to safety and tolerability.
The company previously completed a Phase I trial of ANG1005 in patients with recurrent glioma, which showed promising signs of anti-tumour activity.
According to the company, ANG1005 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.
Around 200 patients were involved in three clinical trials of ANG1005, which include two Phase I trials where the product has shown tolerability similar to paclitaxel and indications of activity, and a Phase II trial for which the intent-to-treat (ITT) analysis showed encouraging signs of anti-tumour activity.
The company started the multi-study Phase II clinical programme in order to further confirm the clinical activity of ANG1005 observed in the earlier studies.
ANG1005 is a derivative of paclitaxel that uses proprietary receptor-targeting peptide technology to cross the blood-brain barrier for the treatment of tumours in the brain, including primary tumors and cancers that have metastasized to the brain.
Image: A high magnification micrograph of an oligodendroglioma. Photo: courtesy of Nephron.