Tiziana Life doses first patient in Phase 2a trial of intranasal foralumab

Tiziana Life Sciences announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis. Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm. The primary endpoint of the trial will be the change in microglial activation based on PET scans. Clinical evaluations include the Expanded Disability Status Scale, QoL assessments, and the Modified Fatigue Impact Scale, which assess parameters that are essential to a patient’s everyday life. Novel immuno-biomarkers will be measured also and assessed for predictive relevance. Central review of PET scans and images is an integral component of this study. Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences said, “I believe that our dosing of the first patient confirms Tiziana’s ability to execute on its commitments and potential to advance our fully human intranasal anti-CD3 mAb, foralumab, using novel imaging methods and clinically relevant endpoints. We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease. Currently, there are no FDA approved treatments for na-SPMS.”