PHILADELPHIA--(ACR Image Metrix™, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, is pleased to announce a Phase III trial, conducted for Aegerion Pharmaceuticals, Inc., was published as an abstract in the online supplement of Atherosclerosis and presented at the 78th European Atherosclerosis Society Congress, which took place June 20-23, 2010, in Hamburg, Germany.)--
“We are pleased to have partnered with Aegerion Pharmaceuticals to conduct this trial”
The trial, titled “Phase III Study of Microsomal Triglyceride Transfer Protein Inhibitor (MTP-I) Lomitapide in Subjects with Homozygous Familial Hypercholesterolemia (HoFH),” was a 56-week assessment of the efficacy and safety of Aegerion Pharmaceuticals’ MTP-I lomitapide in adults with HoFH. In order to measure the percentage of hepatic fat, ACR Image Metrix employed magnetic resonance spectroscopy (MRS) as the imaging modality for this study. MRS is capable of displaying minute differences in the magnetic properties of different chemical compounds to provide a unique biochemical signature.
Aegerion Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of therapeutics/pharmaceuticals to treat cardiovascular (CV) and metabolic disease. A developer of lomitapide (AEGR-733), a novel proprietary MTP-I under development for the treatment of dyslipidemia (abnormal lipid levels in the bloodstream), Aegerion Pharmaceuticals turned to the imaging experts at ACR Image Metrix to execute the trial.
Because of its unique capabilities in employing novel imaging technologies in drug development trials, ACR Image Metrix was chosen for this groundbreaking clinical trial testing the efficacy and safety of an MTP inhibitor.
“We are pleased to have partnered with Aegerion Pharmaceuticals to conduct this trial,” stated general manager of ACR Image Metrix, Michael J. Morales. “The complexity involved allowed our world class team of radiologists and imaging scientists to utilize their widespread knowledge and extensive imaging capabilities.”
At the conclusion of the trial, ACR Image Metrix was able to provide Aegerion Pharmaceuticals with the necessary results to analyze the product effects. In a preliminary analysis, of the eleven adults with HoFH treated with lomitapide, their mean low-density-lipoprotein cholesterol (LDL-C) reduction was 38 percent and hepatic fat had significantly declined.
About ACR Image Metrix™
ACR Image Metrix™, an imaging contract research organization (CRO) located in the American College of Radiology Clinical Research Center in Philadelphia, applies imaging techniques to improve the efficiency of drug and medical device development programs. The world class team of radiologists and imaging scientists at ACR Image Metrix works with pharmaceutical, biotech and medical device companies to integrate the appropriate imaging technologies, modalities and clinical design techniques into their imaging studies. ACR Image Metrix has years of experience utilizing state-of-the-art technologies to provide a complete line of imaging services from site qualification and training, study initiation, image management, reader studies and much more.