Atara Biotherapeutics Announces FDA Clearance to Proceed with Enrollment at U.S. Sites for Ongoing Global Phase 1 Clinical Study to Evaluate ATA188 in Patients with Progressive or Relapsing-Remitting Multiple Sclero DJNF
Atara Biotherapeutics Announces FDA Clearance to Proceed with Enrollment at U.S. Sites for Ongoing Global Phase 1 Clinical Study to Evaluate ATA188 in Patients with Progressive or Relapsing-Remitting Multiple Sclerosis
SOUTH SAN FRANCISCO, Calif., Jan. 10, 2018 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to proceed with patient enrollment at U.S. sites for its ongoing global Phase 1 clinical study to evaluate ATA188 in patients with progressive or relapsing-remitting multiple sclerosis (MS). ATA188, the Company's off-the-shelf T-cell immunotherapy using a complementary targeted antigen recognition technology licensed from QIMR Berghofer Medical Research Institute, selectively targets specific Epstein-Barr virus (EBV) antigens believed to play an important role in the pathogenesis of MS. Atara initiated the open-label, single arm Phase 1 study in MS patients in the fourth quarter of 2017 in Australia.
"We are pleased with FDA's decision to allow off-the-shelf ATA188 to proceed into clinical development in patients with MS in the U.S.," said Chris Haqq M.D., Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Atara Biotherapeutics. "We believe that an off-the-shelf T-cell immunotherapy such as ATA188 may allow for a more consistent reactivity against target EBV antigens, which may be correlated with clinical improvements based on data from a previous autologous ATA190 Phase 1 study in patients with progressive MS. We look forward to the first results from the ATA188 Phase 1 study in patients with progressive MS in the first half of
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