BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, has entered into an agreement with Dana-Farber Cancer Institute (Dana-Farber) to provide cGMP-compliant clean room facilities for production of its NurOwn stem cell candidate during its upcoming phase II ALS trial in the USA. The phase II trial will be launched in the second half of 2013 with pending US FDA approval.

The clinical trial will be conducted at Massachusetts General Hospital (MGH), the University of Massachusetts (UMass) Hospital and the Mayo Clinic. The Connell and O'Reilly Cell Manipulation Core Facility at Dana-Farber will produce NurOwn for the MGH and UMass Hospital clinical sites.

“We are pleased to begin this work that could be of great value to ALS patients,” said Dr Jerome Ritz, director of the Connell and O'Reilly Cell Manipulation Core Facility at Dana-Farber and Professor of Medicine at Harvard Medical School. “This is exactly the kind of service that the facility was set up to provide. We appreciate the opportunity to work closely with BrainStorm and colleagues at MGH and UMass to advance cell therapy solutions for difficult diseases.”

Alon Natanson, Chief Executive Officer of BrainStorm said, “Today’s announcement brings us another step closer to developing a potentially effective treatment option for patients with ALS.” Natanson further added, “With plans in place at leading institutions like MGH, UMass, Mayo Clinic and Dana-Farber, we believe the company is well positioned to conduct our next phase II trial at the highest clinical standards and with maximum efficiency.”

Results of a phase I/II clinical study of BrainStorm’s NurOwn technology in patients with ALS were recently presented at the 65th Annual Meeting of the American Academy of Neurology. The data demonstrated 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 injection of the cells in the six months following treatment, as compared to the three months preceding treatment.

NurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells 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.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases.