USA-based Alnylam Pharmaceuticals has initiated a Phase I trial of ALN-VSP, an RNAi therapeutic developed by Canada-based firm Tekmira for the treatment of advanced liver cancers, including hepatocellular carcinoma.
The multicenter, open-label, dose-escalation study will enroll around 55 patients presenting advanced solid tumors 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, change in tumor blood flow or vascular permeability and change in plasma biomarkers of angiogenesis.
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