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Alnylam Data Shows 'Predictable Correlation' of Clinical, Preclinical Findings on Cancer Drug

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Alnylam Pharmaceuticals this week released new data from an ongoing phase I study of its liver cancer drug ALN-VSP02.

The drug comprises two siRNAs, one targeting vascular endothelial growth factor and one targeting kinesin spindle protein, both of which the firm said are critical for the growth and survival of cancer cells. It is formulated in a first-generation lipid nanoparticle developed by partner Tekmira Pharmaceuticals.

According to Alnylam, new human pharmacokinetic data show "a clear relationship of human and preclinical animal research findings."

Previous studies indicated that human pharmacokinetic parameters for the drug were dose proportional with no evidence of cumulative effects upon patient re-dosing. "Based on new comparative analyses, human [pharmacokinetics] of ALN-VSP02 were found to correlate within a factor of only one- to two-fold with … results from pre-clinical animal research studies," Alnylam said.

"These new data thus demonstrate a predictable level of human exposure for RNAi therapeutics" using Tekmira's technology, it added.

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