NEJM Publishes Positive Clinical Data on Treatment for Hypertriglyceridemia
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)
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Transforming Research: The Intersection of Ethics, Biosafety, and Innovation
October 14th 2024Increased interest in cell and gene therapies has led to increased demand for expertise to help sponsors, CROs, and sites coordinate human gene transfer (HGT) research. Compared to clinical trials with older, more traditional classes of drug products, there are important similarities and differences in requirements for safe and ethical conduct of clinical trials of gene therapy and related modalities.
