Genentech becomes Founding Sponsor for OPT-UP clinical study in MS, says ACP

Accelerated Cure Project for MSOct 8 2015

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.