Isis Pharma fuels fervor for cardio drug with more midstage data

Isis Pharmaceuticals ($ISIS) has revealed more enticing details about its midstage program for a blood-fat-lowering drug. After wowing investors with data from a Phase II study in diabetics last month, the Carlsbad, CA-based biotech group has served up another round of promising results from a small trial of the therapy in patients with high triglycerides on fibrates.

Shares of Isis jumped 3.64% in premarket trading Monday.

The latest Phase II results showed that patients on Isis's therapy, called ISIS-APOCIIIRx, scored up to 64% drops in triglycerides, which are blood fats associated with increased risk of cardiovascular disease. Investigators found increases of up to 52% of HDL or "good" cholesterol and up to a 77% drop in very low-density lipoprotein (LDL) particles linked with apoC-III. The therapy is designed to block activity of the apoC-III gene, which plays a role in regulating serum triglycerides.

"We believe this data solidifies ISIS-APOCIIIRx as one of the leading value drivers at Isis," Needham & Co analyst Chad Messer wrote in a note to clients, as cited by Reuters.

The data come from 26 patients dosed for 13 weeks on either 200 mg or 300 mg of Isis's experimental therapy or placebo. Isis plans to roll out midstage data from a study of patients taking the therapy as a standalone agent. And next year the company aims to begin a Phase III study of the treatment.

"The data presented today on ISIS-APOCIIIRx are very encouraging because they show that ISIS-APOCIIIRx is additive to fibrates and are consistent with Isis' previous Phase 2 data in patients with moderately elevated triglycerides and type 2 diabetes," stated Dr. Daniel Gaudet of the department of medicine at the University of Montreal, who is also scientific director of the Genome Quebec Biobank Technology Center, in a press release. "In both studies, rapid, robust reductions in apoC-III and triglycerides were observed. The positive effect of ISIS-APOCIIIRx on other key lipid parameters demonstrates the potential for ISIS-APOCIIIRx to provide therapeutic benefit to patients with very high triglycerides."

Isis's drug stems from its antisense platform for making drugs that shut down disease-related genes. Like many new biotech platforms, the technology has taken years to materialize into effective treatments, yet 2013 is shaping up to be a banner year for the company. In January, Isis and partner Genzyme, a unit of Sanofi ($SNY), scored FDA approval for the antisense drug Kynamro on patients with a genetic disease that causes high cholesterol called homozygous familial hypercholesterolemia.

- here's the release
- check out Reuters' article

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