EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany and the Accelerated Cure Project for Multiple Sclerosis today announced a lead founding sponsor agreement to help launch the Optimizing Treatment—Understanding Progression (OPT-UP) study.
OPT-UP is a U.S.-based, multicenter longitudinal clinical research study that will enroll 2500 people with MS and follow them for up to five years. The goals of the study are to generate a robust evidence base of factors affecting treatment outcomes in MS to guide the choice of treatments and other interventions for MS patients, and to produce knowledge and tools for developing strategies and/or medicines to slow, arrest, or reverse MS progression.
“Our collaboration with the Accelerated Cure Project on the OPT-UP clinical research study offers us an extraordinary opportunity to combine complementary expertise and resources to improve patient outcomes,” said Dr. Thorsten Eickenhorst, senior vice president and chief medical officer, EMD Serono. “This study underscores our company’s dedication to furthering breakthrough scientific research that can advance treatment options for those living with multiple sclerosis.”
“We have been working diligently with leading MS clinicians, people living with MS, biopharma companies, and foundations to design a study that addresses the most critical medical needs in MS today,” said Robert McBurney, president and CEO of the Accelerated Cure Project for MS. “We are thrilled that EMD Serono, a leader in the area of MS therapeutics, has chosen to take a lead founding sponsor role, providing the support needed to implement this important study.”
Subjects will be enrolled at up to twenty MS clinics located throughout the U.S. and will be followed for a minimum of two years and up to five years. Using validated and standardized instruments, researchers will collect high-quality data on treatment outcomes, biological samples, and imaging data that will be analyzed by the ACP network investigators and partner organizations, as well as shared widely with research groups that can help accomplish the goals of OPT-UP.
“Although progress has been made in making more therapies available to people living with MS, we still make a lot of treatment decisions based on trial and error,” said R. Philip Kinkel, director of the MS Program at the University of California San Diego and Chair of the OPT-UP Steering Committee. “The OPT-UP study objective is to provide data and insights to better match people living with MS with the treatments.”
“In addition to data from clinical assessments, researchers will also have access to patient-reported outcomes that will be captured online at regular intervals,” said Ben Greenberg, director of the Neurosciences Clinical Research Center at the University of Texas Southwestern. “I believe that the substantial amount of data and biosamples generated by this study will be enormously valuable in furthering our understanding of MS disease progression.”
As of September 2014, nine sites are participating in OPT-UP including the University of California San Diego, University of Texas Southwestern Medical Center, University of Massachusetts Medical School, Tisch MS Research Center of New York, Johns Hopkins School of Medicine, Ohio State University Medical Center, the Shepherd Center in Atlanta, University of Colorado School of Medicine, and Stanford University School of Medicine.
Date: September 10, 2014
Source: EMD Serono, Inc.