Multiple Sclerosis Immunotherapy Clinical Trial Expands to United States
An investigational immunotherapy for multiple sclerosis targets Epstein-Barr virus.
Atara Biotherapeutics recently announced it received FDA clearance to start enrolling patients in a clinical trial evaluating an experimental immunotherapy for multiple sclerosis (MS), according to a press release.
The new phase 1 clinical trial will investigate ATA188, an immunotherapy that uses complementary targeted antigen recognition technology. This investigational treatment specifically targets Epstein-Barr virus antigens, which are thought to be involved with MS.
A phase 1 clinical trial of ATA188 was previously launched in Australia in 2017, according to the release.
The primary objective of the ongoing clinical trial is to evaluate the safety of the immunotherapy in patients with MS who were treated for at least 1 year. Secondary endpoints include measures of clinical improvement, including expanded disability status scale, annualized relapse rate, and MRI imaging.
The clinical trial is expected to enroll 30 patients with primary progressive MS or secondary progressive MS and 30 patients with relapsing-remitting MS, according to the release.
“We are pleased with FDA’s decision to allow off-the-shelf ATA188 to proceed into clinical development in patients with MS in the US,” said Chris Haqq MD, PhD, 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 2019.”