-- Study to enable optimal treatment strategies for MS is expected to start Q1 2016 --
WALTHAM, Massachusetts, Oct. 8, 2015 /PRNewswire/ -- Accelerated Cure Project for Multiple Sclerosis (ACP) announced today that Genentech, Inc., a member of the Roche Group, has become a Founding Sponsor for the Optimizing Treatment - Understanding Progression (OPT-UP) clinical study in multiple sclerosis (MS).
ACP has led the development of OPT-UP, a U.S.-based, multicenter longitudinal clinical research study that will enroll 2,500 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 disease-modifying therapeutics (DMTs) 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.
"Together with people living with MS, leading MS clinicians and biopharma companies, we have designed a clinical research study that addresses the most critical medical needs in MS today, particularly the unpredictability of treatment response for individual patients, which can be demoralizing for people with MS and their clinicians," said Robert McBurney, President and CEO of the Accelerated Cure Project for MS. "We are delighted that Genentech has chosen to sponsor the OPT-UP study."
Genentech joins OPT-UP's Lead Founding Sponsor, EMD Serono, and the National MS Society in providing funding for the OPT-UP study. ACP expects that other MS stakeholders will soon join the OPT-UP Founding Sponsors group and that this important study will begin enrolling patients in early 2016.
People with MS will be enrolled in OPT-UP at up to 20 MS clinics located throughout the U.S. and will be followed for a minimum of two years and up to five years as they make choices of DMTs and any subsequent switches to other DMTs. Using validated and standardized in-clinic assessments and online questionnaires, the OPT-UP study will collect high-quality data on treatment outcomes, along with biological samples and imaging data collected under standardized protocols and processed by commercial vendors under standardized operating procedures. These comprehensive resources 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.
"Despite the availability of many DMTs, physicians and patients still make many 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 primary OPT-UP study objective is to provide robust evidence that can enable physicians and their patients to decide on the optimal treatment strategy for each individual person living with MS. This study exemplifies a new generation of clinical studies designed to enable personalized, or precision, medicine."
"In addition to standard clinic-based assessments from the OPT-UP study, researchers will also have access to critically-important patient-reported outcomes that will be captured online at regular intervals," said Benjamin 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 also be enormously valuable in furthering our understanding of MS disease progression."
As of October 2015, nine clinical 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. ACP is currently seeking additional qualified clinical sites for the study. For more information about the OPT-UP study and how sites, sponsors, and other stakeholders can get involved, please contact Accelerated Cure Project for MS.
About Accelerated Cure Project for MS ACP is a patient-founded non-profit organization dedicated to accelerating research efforts to improve diagnoses, optimize treatment outcomes, and develop cures for MS. The ACP team has proven experience in developing and sharing resources with MS researchers. The organization promotes scientific collaboration and accelerates research by rapidly and cost-effectively providing researchers with the resources they need, such as biosamples, data, research information and access to patient-reported outcomes, to pursue novel research ideas that can lead to better care for people living with MS. ACP leads the iConquerMS™ initiative, a patient-powered research network that is part of PCORnet, the national patient-centered outcomes research network. ACP's deep MS knowledge and community relationships have driven efforts to build and grow iConquerMS™. Through its Repository program, ACP has provided biosamples and data resources to support over 90 research studies worldwide that have generated over 1 trillion returned data points for collaborative data mining and disease modeling. ACP also manages the MS Discovery Forum, an online resource that helps researchers, people with MS and other MS stakeholders across the globe stay abreast of key findings by delivering high-quality news and information about research activities in multiple sclerosis and other demyelinating disorders.
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 are living with 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.