March 21, 2013
RESULTS OF NUROWN™ CLINICAL TRIAL SUGGEST EFFICACY IN ALS PATIENTS
Data Indicate Initial Clinical Benefit in Overall Clinical and Respiratory Function
New York, NY and Petach Tikvah, Israel – March 21, 2013 – BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today reported some of the final results from a clinical study evaluating the company’s NurOwn™ technology in 12 ALS patients. NurOwn is a proprietary, first-of-its-kind technology for the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into NeuroTrophic Factor (NTF)-secreting cells. The data were presented yesterday, Wednesday, March 20, 2013 during the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, California.
An oral and poster presentation were made in the Emerging Science Session by Principal Investigator Dimitrios Karussis, M.D., Ph.D., entitled, “Analysis of 12 Patients with Amyotrophic Lateral Sclerosis (ALS) Treated with Autologous Differentiated Mesenchymal Stem Cells: a Phase I/II Clinical Trial.” Karussis reported a significantly slower decline in overall clinical and respiratory function, as measured by the ALS Functional Rating Score (ALSFRS-R) and Forced Vital Capacity (FVC) score respectively, in the six patients that received an intrathecal (IT) injection of the cells in the six months following treatment, as compared to the three months preceding treatment. The study concluded that in addition to establishing the safety of the treatment protocol, initial indications of clinical benefit were observed, which require further confirmation in additional trials. The company is currently conducting a Phase IIa dose-escalating trial pursuant to recent acceleration by the Israeli Ministry of Health.
“These encouraging results confirm the importance and therapeutic potential of NurOwn as a breakthrough treatment for patients with ALS,” said Prof. Karussis, Head of the Neuroimmunology Laboratory, Department of Neurology, Hadassah Medical Center, Jerusalem. “Additionally, beyond its benefit in treating patients with ALS, NurOwn may have utility in the treatment of other severe neurodegenerative and neuroimmunological conditions including multiple sclerosis and Parkinson’s disease.”
“We are excited by these data and the potential of NurOwn to positively impact the lives of patients with ALS,” said Alon Natanson, Chief Executive Officer of BrainStorm. “We look forward to continuing to advance this potentially important therapy. To that end, we have begun a Phase IIa dose-escalating trial at Hadassah and plan to launch a multi-center Phase II trial in the USA later this year in order to further validate the results that were presented today.”
About NurOwn™
NurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells (MSC) into specialized, neuron-supporting cells. These neuron-supporting cells (known as “MSC-NTF” cells) secrete neurotrophic, or nerve-growth, factors for PROTECTION of existing motor neurons, PROMOTION of motor neuron growth, and RE-ESTABLISHMENT of nerve-muscle interaction. The ability to differentiate mesenchymal stem cells into MSC-NTF cells, and confirmation of their activity and potency before transplantation, makes NurOwn a first-of-its-kind approach for treating neurodegenerative diseases. More information about NurOwn™ can be found at http://brainstorm-cell.com/index.php/science-a-technology/-nurown.