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13:54 EDT Atara Biotherapeutics presents initial ATA188 Phase 1 safety results - Atara Biotherapeutics announced initial ATA188 Phase 1 safety results for patients with progressive multiple sclerosis at the 5th Congress of the European Academy of Neurology in Oslo, Norway. ATA188, Atara's off-the-shelf, allogeneic T-cell immunotherapy, targets specific Epstein-Barr virus antigens believed to play an important role in the pathogenesis of MS. The primary objective of Atara's ongoing ATA188 Phase 1, dose-escalating clinical study is to evaluate safety and tolerability for patients with progressive MS. Initial safety results as of April 8, 2019, showed that the first three ATA188 dose cohorts were well tolerated with no dose-limiting toxicities and no greater than or equal to 3 grade treatment-related, treatment-emergent adverse events. The study is continuing with the objective of identifying a recommended Phase 2 dose. In addition, a randomized, double-blind, placebo-controlled Phase 1b extension period for this study using the RP2D is now planned following completion of the open-label, dose-escalation period. Key secondary endpoints of the Phase 1 study include measures of clinical improvement such as expanded disability status scale and MRI imaging as well as other clinical activity measures. The study is expected to enroll a total of 24-30 primary and secondary progressive MS patients in the U.S. and Australia.
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