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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

Study Links Evolution of Longevity, Social Organization in Mammals

With the help of comparative phylogenetics and transcriptomics, researchers in Nature Communications see ties between lifespan and social organization in mammals.

Tumor Microenvironment Immune Score Provides Immunotherapy Response, Prognostic Insights

Using multiple in situ analyses and RNA sequence data, researchers in eBioMedicine have developed a score associated with immunotherapy response or survival.

CRISPR-Based Method for Finding Cancer-Associated Exosomal MicroRNAs in Blood

A team from China presents in ACS Sensors a liposome-mediated membrane fusion strategy for detecting miRNAs carried in exosomes in the blood with a CRISPR-mediated reporter system.

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.