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FDA Clears Tekmira to Begin Phase I Study of siRNA-Based Cholesterol Drug

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The US Food and Drug Administration has approved Tekmira Pharamceuticals' investigational new drug application for its siRNA-based hypercholesterolemia drug ApoB SNALP, the company said this week.

The drug targets apolipoprotein B, a protein involved in cholesterol metabolism. In the planned phase I study, escalating doses of ApoB SNALP will be examine for safety, tolerability, and pharmacokinetics in about 30 adults with elevated low-density lipoprotein cholesterol, according to the company.

The trial is also expected to yield some data on the drug's ability to lower serum LDL cholesterol levels, Tekmira added. Results from the study are expected in late 2009 or early 2010.

The Scan

Gone, But Now Reconstructed SARS-CoV-2 Genomes

In a preprint, a researcher describes his recovery of viral sequences that had been removed from a common database.

Rare Heart Inflammation Warning

The Food and Drug Administration is adding a warning about links between a rare inflammatory heart condition and two SARS-CoV-2 vaccines, Reuters reports.

Sandwich Sampling

The New York Times sent tuna sandwiches for PCR analysis.

Nature Papers Describe Gut Viruses, New Format for Storing Quantitative Genomic Data, More

In Nature this week: catalog of DNA viruses of the human gut microbiome, new dense depth data dump format to store quantitative genomic data, and more.