Business
Atara Biotherapeutics Announces First Patient Enrolled in Randomized Placebo-Controlled Study of Allogeneic T-cell Therapy ATA188 in Progressive Forms of Multiple Sclerosis
Based on promising results from the Phase 1a study including sustained disability improvements among progressive MS patients, the Phase 1b study will assess
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\n Based on promising results from the Phase 1a study including sustained disability improvements among progressive MS patients, the Phase 1b study will assess clinical outcomes including measures of disability, physical and cognitive function, biomarkers and MRI imaging as well as safety\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop treatments for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease, today announced the first patient has been enrolled in a Phase 1b study of ATA188, an off-the-shelf, allogeneic EBV-specific T-cell immunotherapy, in patients with progressive forms of multiple sclerosis (MS).\n\n\nThe Phase 1b study (NCT03283826) is a double-blind randomized placebo-controlled study evaluating the efficacy and safety of ATA188. In addition to measuring change in disability measures compared to baseline, especially sustained improvement over time, the Phase 1b study will also include multiple measures of patients’ function as well as various biomarkers. Types of data to be collected include: standard disability measures (EDSS, timed 25 foot walk test, 9 hole peg test); cognition and outpatient ambulatory activity; patient-reported fatigue; visual acuity; biomarkers in blood and cerebrospinal fluid (CSF); and, MRI imaging.\n\n\n“We are thrilled at the investigator and patient interest in our randomized placebo-controlled Phase 1b study assessing the efficacy and safety of ATA188,” said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of Atara Biotherapeutics. “The initiation of this study, including first-patient-enrolled, is an important step in further assessing the potential of ATA188 in progressive MS, a complex disease of high unmet medical need where disability continues to progress despite approved treatment options. Based on the promising results of safety and sustained disability improvements seen to date in the Phase 1a study, we look forward to continuing enrollment in this randomized placebo-controlled study with the goal of developing a transformative therapy for patients that could halt or reverse the progression of this severe disease.”\n\n\nParticipants in clinical sites across the U.S. and Australia...