Tekmira Pharmaceuticals Corporation announced that one of the company's collaborators, Alnylam Pharmaceuticals, Inc, has initiated a phase-1 human clinical trial of ALN-VSP in the United States. ALN-VSP, a product that utilizes Tekmira's SNALP technology, is being developed as a treatment for advanced liver cancers, including hepatocellular carcinoma and other solid tumours with liver involvement. A milestone payment is payable to Tekmira upon the initiation of the phase-1 trial and additional milestone payments become due as ALN-VSP is advanced through development.

Dr Mark J Murray, Tekmira's president and CEO, said "We are pleased that Alnylam has initiated their phase-1 clinical trial of ALN-VSP as this represents an important milestone in the advancement of our SNALP technology. We will continue to support Alnylam and the ALN-VSP product as we manufacture the ALN-VSP clinical supplies on behalf of Alnylam."

ALN-VSP contains small interfering RNA (siRNA) molecules formulated for systemic delivery with Tekmira's SNALP technology. Tekmira has supported Alnylam in their advancement of ALN-VSP by generating preclinical data, providing analytical services and in the manufacture of ALN-VSP for clinical trials. Pre-clinical data in mouse tumour model studies have demonstrated robust efficacy of ALN-VSP, including suppression of targeted genes, demonstration of an RNAi mechanism of action, tumour reduction, and extension of survival.

Alnylam's ALN-VSP phase-I trial, being conducted in the US, is a multi-center, open label, dose escalation study designed to enrol approximately 55 patients with advanced solid tumours with liver involvement, who have failed to respond to or have progressed after standard treatment.

The primary objective is to evaluate the safety, tolerability, and pharmacokinetics of intravenous ALN-VSP, including demonstration of the maximum tolerated dose. Other exploratory objectives include the assessment of tumor response through Response Evaluation Criteria for Solid Tumours (RECIST), a set of published guidelines that define when cancer patients' disease improves, stabilizes or progresses during treatment; change in tumour blood flow or vascular permeability measured by DCE-MRI; and, change in plasma biomarkers of angiogenesis. In addition, the analysis of pharmacodynamic effects of ALN-VSP on tumours will be measured in patients electing to proceed with voluntary pre- and post-treatment biopsies.

Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners.