Israeli biotech firm’s ALS treatment shows safety of use in trials – The Jerusalem Post

Ness Ziona-based biotech firm Kadimastem has shown encouraging results of Cohort B of its Phase 1/2a clinical trial for AstroRx, its Amyotrophic Lateral Sclerosis (ALS) treatment trial. The objective of this trial was to evaluate the safety of their treatment, with a secondary objective of the trial of estimating its preliminary efficacy. The treatment was developed by Kadimastem and contains functional, healthy astrocytes (nervous system support cells) derived from Human Embryonic Stem Cells (hESC) that aim to protect diseased motor neurons. The company's technology allows injecting AstroRx into the spine of the patient, to slow down the progression of the disease. The treatment has been granted orphan drug designation by the FDA for the treatment of ALS. The five patients included in this part of the trial showed no serious adverse effects during the half a year follow up after the treatment was given. The rate in which it slows down the disease was also tested for, using the ALS Functional Rating Scale-Revised (ALSFRS-R), which tracks ALS progression, and has shown that after the treatment was given, there was a 45% decline in the disease's progression rate. At the end of the 6-month post-treatment period, the rate of ALSFRS-R progression was similar to the rate that was measured before treatment. "The results after 6 months of follow up are encouraging, as they suggest a clinically meaningful signal of effect for 3 months by a single administration of AstroRx and confirm the safety of AstroRx," said Dr. Marc Gotkine, Head of the ALS Clinic at the Department of Neurology at Hadassah Medical Center in Jerusalem, and the Principal Investigator of the trial.

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Israeli biotech firm's ALS treatment shows safety of use in trials - The Jerusalem Post