BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), 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.
“We are very excited by this new approach to develop neuronal supporting cells; the hope is that these cells will be neuroprotective and clinically beneficial in several neurological diseases, such as ALS and Parkinson's Disease”
"The Israeli Ministry of Health's clearance of our NurOwn™ 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™ 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.
"I am extremely pleased to learn about this new development," said Dr. Jacob Frenkel, Chairman of JPMorgan Chase International and a member of the JPMorgan Chase (NYSE:JPM) Executive Committee and its International Council and a member of the Advisory Board of BrainStorm. "I wish to express my appreciation to the Israeli Ministry of Health for approving BrainStorm's application and allowing the researchers in the company to try to bring hope for the patients who are waiting anxiously for a successful treatment."
"We are very excited by this new approach to develop neuronal supporting cells; the hope is that these cells will be neuroprotective and clinically beneficial in several neurological diseases, such as ALS and Parkinson's Disease," said Robert H. Brown Jr., M.D. Ph.D., Professor and Chair of Neurology at the University of Massachusetts Medical School. "Successful slowing of these diseases using these neural-supporting mesenchymal cells would have a profound impact on the field. If safe and effective, this new therapy could become a treatment option for thousands of patients."
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