NEJM Publishes Positive Clinical Data on Treatment for Hypertriglyceridemia

August 12, 2015
Company Press Release

Applied Clinical Trials

Raleigh, NC (August 12, 2015) -The New England Journal of Medicine (NEJM) recently published results of a multi-center clinical trial, managed by CTMG, examining the safety and efficacy of a novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia (severely elevated triglyceride levels)[1].

The completion of the study included a collaborative effort between CTMG and Isis Pharmaceuticals, creator of volanesorsen. CTMG, the world’s first site specific research organization (SSRO). CTMG’s protocol-specific processes, internal quality systems and rapid reaction time in identifying and eliminating barriers to continued patient participation, ensured all qualified patients were enrolled within nine months, with nearly all completing the year-long study, and providing the highest quality data for FDA review. This successful Phase 2 study provided the data to enable a pivotal Phase 3 study to commence.

The two CTMG Business Associate physician investigators who enrolled the highest numbers of qualified study patients in the CTMG group, Richard Shultzaberger, MD and Charles Jahrsdorfer, MD, are both private practitioners in Greenville, North Carolina.

Volanesorsen is a RNA-targeted therapy that selectively inhibits the production of apolipoprotein C-III (APOC3), a key regulator of plasma triglyceride levels. Hypertriglyceridemia is associated with an increased risk of cardiovascular disease and pancreatitis if untreated in patients with hypertriglyceridemia.

Results from the Phase 2 study showed treatment with volanesorsen resulted in significant lowering of triglyceride levels among patients with a broad range of baseline levels. Average reductions of up to 80 percent in APOC3 and up to 71 percent in triglycerides were observed in the study, with no safety concerns identified.

 

 

 

 

[1] “Antisense Inhibition of Apolipoprotein C-III in Patients with Hypertriglyceridemia,” NEJM,

   July 30, 2015 (http://bit.ly/1eVTdTe)

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