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Tekmira Files IND for Hypercholesterolemia Drug with US Regulators


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.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more