Atara reports FDA clearance to proceed with enrollment for Phase 1 trial
Atara Biotherapeutics announced that it received clearance of its Investigational New Drug application from the U.S. Food and Drug Administration 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. 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 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. The primary objective of Atara's ongoing Phase 1 clinical study is to assess the safety of ATA188 in patients followed for at least one year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale and annualized relapse rate as well as MRI imaging. The study is expected to enroll a total of 60 patients across the U.S., Australia and Europe: 30 patients with progressive forms of MS, either primary progressive MS or secondary progressive MS, and 30 patients with relapsing-remitting MS
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