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Atara Biotherapeutics Reports Early Findings of Potential Efficacy from Phase 1 Study of ATA188 in Patients with Progressive Multiple Sclerosis at ECTRIMS 2019 | ||||||||||||||||||||||||||
By: Nasdaq / GlobeNewswire - 13 Sep 2019 | Back to overview list |
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Enrollment in the fourth and final planned Phase 1 dose escalation cohort completed ATA188 targets Epstein-Barr Virus (EBV)-infected B cells, believed to play a role in the pathogenesis of multiple sclerosis Conference call and webcast today at 3:30 p.m. CEST / 9:30 a.m. EDT SOUTH SAN FRANCISCO, Calif., Sept. 13, 2019 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today announced the presentation of initial efficacy data as well as updated safety results from its ongoing Phase 1 study of ATA188 for the treatment of progressive forms of multiple sclerosis (MS). The data are featured in a late-breaking poster presentation at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in Stockholm, Sweden, September 11-13, 2019. ATA188 is an off-the-shelf, allogeneic T-cell immunotherapy that targets Epstein-Barr Virus (EBV)-infected B cells believed to play a role in the pathogenesis of MS. “I am encouraged by the well tolerated safety profile as well as early findings of potential efficacy in the ongoing ATA188 Phase 1 study,” said Professor Amit Bar-Or, MD, FRCP, FAAN, FANA, Chief of MS Division, Department of Neurology, Perelman School of Medicine at the University of Pennsylvania. “The outcome classification using multiple clinically recognized MS scales is an innovative approach, and I look forward to advancing the study alongside my colleagues for progressive MS patients who have limited treatment options and where continual clinical decline is expected.” The reported initial data as of July 29, 2019 are from a Phase 1, multicenter, open-label, dose-escalation study evaluating the safety and efficacy of ATA188 in patients with progressive forms of MS. In this study, patients were treated across four dose cohorts (5 x 106, 1 x 107, 2 x 107 and 4 x 107 cells), with 6 patients per cohort. Clinical outcome classification Clinical outcomes of ATA188 were assessed at baseline and approximately 3, 6, and 12 months follow up from initial dose using recognized scales for MS symptoms, function and disability including: Expanded Disability Status Scale (EDSS), Fatigue Severity Score, MS Impact Scale-29 (physical), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test, 12-Item MS Walking Scale (MSWS-12) and Visual Acuity (VA). An outcome classification was developed to categorize clinical response by the following clinical criteria:
Safety Safety results showed that across the 4 planned dose cohorts, ATA188 was well tolerated in patients with progressive forms of MS with no evidence of cytokine release syndrome, graft versus host disease or dose-limiting toxicities. Initial efficacy At approximately 6 months from initial dose, 4 of 6 patients in cohort 1 demonstrated clinical decline which was maintained at 12 months. In cohort 2, an outcome classification of clinical improvement or partial clinical improvement was observed in all 6 patients at 6 months. No patients showed an outcome classification of stable or clinical decline. “The safety and efficacy results presented from our ongoing ATA188 Phase 1 study highlight the potential for an off-the-shelf, allogeneic T-cell immunotherapy targeting Epstein-Barr Virus (EBV)-infected B cells in patients with progressive forms of MS,” said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of Atara Biotherapeutics. “Our recent completion of enrollment in the fourth and final dose escalation cohort moves us closer to identifying the dose to initiate a randomized, double-blind, placebo-controlled Phase 1b part of this study. We are committed to advancing ATA188 for MS patients and look forward to presenting additional efficacy and safety results from this study in 2020, including from cohorts 3 and 4.” Atara will host a live conference call and webcast on Friday, September 13, at 3:30 p.m. CEST / 9:30 a.m. EDT to discuss these results, featuring Dr. Lawrence Steinman, professor of Neurology and Neurological Sciences, Pediatrics, and Genetics at Stanford University and former Chair of the Stanford University Interdepartmental Program in Immunology. For more information about the ATA188 Phase 1 study, please visit ClinicalTrials.gov (NCT03283826). Details of the ECTRIMS 2019 presentation
Atara conference call and webcast information Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 3275835. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company's website for approximately 30 days following the live webcast. About Multiple Sclerosis About off-the-shelf, allogeneic ATA188 and autologous ATA190 About Atara Biotherapeutics, Inc. Forward-Looking Statements Editor’s note: Bar-Or is a paid consultant for Atara Biotherapeutics. INVESTOR & MEDIA CONTACT: John Craighead, Ph.D. |
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