EMD Serono Joins ACP to Launch OPT-UP Study
Study aims to optimize treatment and understand progression
The Accelerated Cure Project for Multiple Sclerosis (ACP), which is the parent organization of this news site, and the pharmaceutical company EMD Serono today announced the launch of a project called OPT-UP, a longitudinal study intended to optimize treatment and understand progression in multiple sclerosis. Following is the text of the joint ACP-EMD Serono news release:
Erin-Marie Beals- EMD Serono
Skye Schulte – ACP
September 10, 2014
EMD Serono, Inc. and Accelerated Cure Project Launch Collaborative Research Program to Optimize Treatment and Understand Progression of Multiple Sclerosis
EMD Serono provides funding for ACP’s multicenter longitudinal OPT-UP clinical study
Rockland, MA/Waltham, MA, September 10, 2014 – 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, MD, 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, MD, 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. For more information about the OPT-UP study and how you can get involved, please contact Accelerated Cure Project for MS.
About Accelerated Cure Project for MS
Accelerated Cure Project for MS (ACP) is a nonprofit organization whose mission is to accelerate research efforts to improve diagnosis, to optimize treatment and to cure MS. ACP believes that research is the only way to greatly improve the outlook for people with MS. The organization promotes scientific collaboration and accelerates research by rapidly and cost-effectively providing researchers with data and biospecimens they need to explore novel research ideas that can lead to better diagnoses, to new treatments and to cures for people with MS. Its resources have supported 77 research studies worldwide that have generated almost 700 million returned data points for collaborative data mining and disease modeling. To learn more about the activities, and impact of ACP, please visit http://www.acceleratedcure.org.
About EMD Serono, Inc.
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading US biopharmaceutical company focused exclusively on specialty care. An established leader in the Massachusetts life sciences industry, EMD Serono recently invested in expanding its research and development presence in the state to support the advancement of its pipeline and opportunities for partnerships in the academia and biotech sectors. Today, the EMD presence in Massachusetts includes approximately 2,200 employees, and the combined organizations of EMD Serono and EMD Millipore, the life sciences division of Merck KGaA, make EMD the fifth largest life science company in Massachusetts. EMD Serono engages in strategic partnerships that leverage Massachusetts’ rich biotech innovation hub to advance research in our core therapeutic areas and is also a supporter of science, technology, engineering and medical (STEM) education in Massachusetts. For more information, please visit www.emdserono.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. Its subsidiaries in Canada and the United States operate under the umbrella brand EMD. Around 39,000 employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. The company generated total revenues of €11.1 billion in 2013 with its four divisions: Biopharmaceuticals, Consumer Health, Performance Materials and Life Science Tools. Merck KGaA of Darmstadt, Germany is the world’s oldest pharmaceutical and chemical company – since 1668, the name has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.