AngioChem, Inc, a clinical-stage biotechnology company dedicated to creating and developing new drugs to treat brain diseases, announced that its lead product, ANG1005, is safe and well tolerated in patients with brain cancer treated to date. ANG1005 consists of a proprietary peptide vector (Angiopep) that transports drugs across the blood-brain barrier (BBB) conjugated to three molecules of the anti-cancer agent paclitaxel.

The results, from ongoing phase-I/2 studies in the US and preclinical vector delivery data, were presented today at the 20th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (Geneva, Switzerland).

"This preliminary safety and tolerability data is very encouraging but we are still in the early stages of clinical development and dose-escalation continues. We know from our preclinical data that our platform Angiopep vector technology is able to deliver not only paclitaxel to the target brain cells but also any other type of drug, including peptides , monoclonal antibodies siRNAs and other biologicals," said Dr Jean-Paul Castaigne, chief executive officer of AngioChem. "Brain disease is a huge market, worth around US$65 billion a year, yet there still remains a significant unmet medical need for effective treatments. In many diseases, effective drugs candidates have been identified; the issue is getting them into the brain so that they are able to work effectively. We believe our Angiopep technology has the ability to transport these drugs candidates across the blood-brain barrier, thus treat many diseases of the central nervous system."

AngioChem is conducting two parallel phase-1/2 studies involving approximately 30 patients per study: one study treating recurrent glioblastoma and a second study treating brain metastasis. The primary endpoint of both studies is safety, tolerability and determination of the maximum tolerated dose (MTD). Secondary endpoints include determination of the pharmacokinetic profile of ANG1005, a preliminary assessment of efficacy, as well as the measurement of ANG1005 levels in surgically removed tumours from glioblastoma patients. Both studies are being conducted at multiple sites in the United States. Top-line data from the studies are expected before the end of 2008.

In the first clinical trial presented (Abstract 424), data from 22 patients with advance solid tumors with brain metastases showed that doses of ANG1005 up to 500 mg/m2 were safe and well tolerated. ANG1005 is administered by intravenous infusion for 1 hour every 21 days. Doses of the drug continue to be increased as part of the ongoing clinical study.

The second trial presented (Abstract 425) included data from the first 12 patients with malignant glioma treated to date. The data showed that ANG1005 administered by intravenous infusion for 1 hour every 21 days is safe and tolerable up to and including doses of 105 mg/m2. The dose of the drug continues to be increased as part of the ongoing clinical trial.

The key challenge to treating brain diseases is the blood-brain barrier (BBB), which prevents more than 95 per cent of drugs from penetrating the brain.

AngioChem is a Canadian clinical-stage biotechnology company dedicated to creating and developing new drugs to treat brain diseases.