HACKENSACK, N.J. and PETACH TIKVAH, Israel, Oct. 7, 2015 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the final patient has been treated in its multicenter Phase 2 clinical trial investigating the company's proprietary NurOwn™ stem cell technology. The trial is a double blind, placebo-controlled, clinical trial which targeted enrollment of 48 patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.
The study was designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn™). The trial is being conducted at the Massachusetts General Hospital (MGH) in Boston, MA, University of Massachusetts Memorial (UMass) Hospital in Worcester, MA, and Mayo Clinic in Rochester, Minnesota.
"We are pleased to have successfully completed all transplantations," said principal investigator, Prof. Anthony J. Windebank, MD, "In six months, we expect to complete follow-up visits on the last patients, and we are looking forward to seeing the analysis of the complete results. The initial safety profile has been excellent and the treatment generally well-tolerated – which is a primary goal of the study."
"We are proud to announce the completion of dosing of this multicenter study on schedule, which is one of the company's most important milestones to date. Importantly, this is the first trial to compare NurOwn with placebo," said Chaim Lebovits, CEO of BrainStorm. "We are extremely thankful for having the opportunity to collaborate with three top-tier US medical centers – MGH, UMass and Mayo Clinic. And we would like to express our special appreciation and thanks to our team of PI's – Prof. Robert H. Brown, MD, DPhil, Chair of the Neurological Department at UMass, Prof. Merit Cudkowicz, MD, MSc, Chair of the MGH Neurological Clinical Research Institute (NCRI), and Prof. Anthony J. Windebank, MD, Head of the Regenerative Neurobiology Laboratory in the Department of Neurology at Mayo Clinic."
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. NurOwn® has been administered to over 30 patients with ALS in clinical trials conducted in Israel, and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States. 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. These forward-looking statements 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.
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