NEW YORK, NY and PETACH TIKVAH, ISRAEL--(Marketwired - April 08, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that Dana-Farber Cancer Institute ("Dana-Farber") has entered into an agreement to provide cGMP-compliant clean room facilities for production of BrainStorm's NurOwn™ stem cell candidate during its upcoming Phase II ALS trial in the USA. The Company's Phase II trial, to be launched in the second half of 2013 pending FDA approval, 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."
"Today's announcement brings us another step closer to developing a potentially effective treatment option for patients with ALS," said Alon Natanson, Chief Executive Officer of BrainStorm. "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.
About BrainStorm Cell Therapeutics, Inc.
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. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the company's website at www.brainstorm-cell.com.
Safe Harbor Statement - Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.