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200 ALS Patients Finish Dosing in Phase 3 Trial of NurOwn Cell Therapy

Posted By On In ALS,Biotech (General),Clinical Trials | Comments Disabled
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Patient dosing has finished in the pivotal Phase 3 trial assessing the safety and efficacy of repeat administrations of NurOwn [5], a cell-based therapy for people with amyotrophic lateral sclerosis [6] (ALS), BrainStorm Cell Therapeutics [7], the therapy’s developer, announced [8].

The Phase 3 trial (NCT03280056 [9]), which enrolled about 200 participants [10], is underway at six U.S. sites: the University of California, Irvine [11]; Cedars-Sinai Medical Center [12]; California Pacific Medical Center [13]; Massachusetts General Hospital [14]; the University of Massachusetts Medical School [15]; and the Mayo Clinic [16].

Patients were randomly assigned to either three doses of NurOwn [17] or a placebo, both administered every other month by injections directly into the spinal canal (intrathecal) over a period of four months.
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Author: Canan Schuman, PharmD/PhD [19]

Canan Schumann is Chief Editor for Axxiem and for Axxiem's blog "BiotechOntheWeb". When not writing for Axxiem, Canan works as a Clinical Research Scientist II at the Research and Development Department at Molecular Testing Labs, developing endpoint assays for the detection of infectious disease and cancer. Canan currently resides in Portland, Oregon, where he received his Honors Bachelor of Science (HBS), Doctor of Pharmacy (PharmD.), and his Doctor of Philosophy (Ph.D.) in Biopharmaceutics at Oregon State University.