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Tekmira Files IND for Hypercholesterolemia Drug with US Regulators

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Tekmira Pharmaceuticals said this week that it has filed an investigational new drug application with the US Food and Drug Administration to begin human testing of an siRNA-based treatment for elevated low-density lipoprotein levels.

The drug, ApoB SNALP, targets apolipoprotein B, a protein involved in cholesterol metabolism. Last month, Tekmira President and CEO Mark Murray said that a planned phase I trial for the therapy is expected to enroll around 30 patients with elevated low-density lipoprotein, and will examine the effects of a single administration of the drug on levels of the cholesterol (see RNAi News, 3/26/2009).

The company said this week that it expects to begin the trial before mid-year, in line with previous guidance. Tekmira disclosed last month that development of its other clinical candidate, the cancer drug PLK1 SNALP, had been delayed and that the drug would not likely reach the clinic until next year.

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