Oct. 11, 2010, 7:00 a.m. EDT · Recommend · Post:

BrainStorm Receives Approval to Begin Clinical Trial of Adult Stem Cell Therapy in Patients with ALS
Building on Nearly Five Years of Research, BrainStorm is the First Company to Receive Clearance from the Israeli Ministry of Health for a Differentiated Stem Cell-Based Therapy in Israel

NEW YORK & PETACH TIKVAH, Israel, Oct 11, 2010 (BUSINESS WIRE) -- BrainStorm Cell Therapeutics Inc. /quotes/comstock/11k!bcli (BCLI 0.25, +0.03, +14.68%) , a leading developer of adult stem cell technologies and therapeutics, today announced that the Israeli Ministry of Health (MOH) has granted clearance for a Phase I/II clinical trial using the company's autologous NurOwn(TM) stem cell therapy in patients with amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease. BrainStorm is the first company to receive clearance from the MOH for a differentiated stem cell-based therapy in Israel.

"The Israeli Ministry of Health's clearance of our NurOwn(TM) clinical trial is one of BrainStorm's most significant accomplishments to date," said Chaim Lebovits, President of BrainStorm. "We believe that our specific differentiated stem cells derived from a patient's own bone marrow could represent a new treatment paradigm for patients with ALS and other neurological disorders."

The Phase I/II clinical trial will be conducted in cooperation with the world-renowned Hadassah Medical Center and will be conducted by a joint team headed by the principal investigator Dimitrios Karussis, M.D., Ph.D., of the Hadassah Medical Center, and a scientific team from BrainStorm headed by Prof. Eldad Melamed. The initial phase of the study is designed to establish the safety of NurOwn(TM) and will later be expanded to assess efficacy.