US RNAi specialist Alnylam Pharmaceuticals has submitted an Investigational New Drug application to the Food and Drug Administration for ALN-VSP, an RNAi therapeutic for the treatment of liver cancers, including hepatocellular carcinoma and other solid tumors with liver involvement.
Following the FDA's review of the submission, the firm expects to initiate patient dosing in the first half of 2009, which positions the company on track to meet its goal of having three programs in clinical trials next year.
The agent contains two small interfering RNAs formulated in a lipid nanoparticle developed by USA-based Tekmira Pharmaceuticals. ALN-VSP is designed to target two genes critical in the growth and development of cancer: kinesin spindle protein, or KSP, required for tumor proliferation; and vascular endothelial growth factor required for tumor growth.
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