Monday, October 11, 2010

BrainStorm Receives Approval to Begin Clinical Trial of Adult Stem Cell Therapy in Patients with ALS

Source: BrainStorm Cell Therapeutics Inc.
Date: October 11, 2010

Summary:

BrainStorm Cell Therapeutics Inc., 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™ 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 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™ and will later be expanded to assess efficacy.

The trial is expected to begin following validation of sterility tests requested by the MOH and screening of patients for the trial. Additional information regarding the process of selecting patients for the Phase I/II clinical trial will be communicated at a later date.