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|BrainStorm Announces Exceptional Preclinical Results of NurOwn™ in Mouse Autism Model|
Hackensack, NJ & Petach Tikvah, Israel – January 26, 2015 – BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced positive results from preclinical studies of NurOwn™ in the BTBR mouse model of autism. NurOwn™ cells are mesenchymal stem cells (MSCs) that have been induced, under BrainStorm’s proprietary methods, to secrete a variety of neurotrophic factors. The BTBR mouse exhibits several stereotypical behavioral characteristics that resemble behaviors seen in autism spectrum disorders, including repetitive behaviors, altered social interactions, cognitive rigidity and impaired adaption to environment.
These studies, conducted in collaboration with Professor Dani Offen, PhD, of Tel Aviv University Chief Scientific Advisor to BrainStorm, assessed the ability of NurOwn™ cells to affect the behavior of BTBR mice. Across all the measures, including assessments of repeated self-grooming, social interaction and cognitive rigidity, NurOwn™ cells demonstrated marked behavioral benefits in BTBR mice after a single treatment, as compared to control group, which consisted of BTBR mice treated only with vehicle.
NurOwn™ cells performed particularly well in an important assessment of reversal of learning. This test evaluates the time it takes to the mice to maneuver in a water maze after the maze was first learned and then altered. In this cognitive rigidity test, NurOwn™-treated BTBR mice adapted quickly to the new conditions, taking 60% less time than the control BTBR mice to relearn the maze (p=0.016). Notably, the cognitive rigidity and social grooming behavior of the treated BTBR mice were similar to those behaviors observed in a normal mouse strain (C57/BL).
BrainStorm’s CEO Tony Fiorino, MD, PhD, stated “These are exciting results from a program we just launched in 2014. The prevalence of autism-spectrum disorders continues to grow, yet with no approved treatments and a limited number of promising drugs in development. We have seen in these mouse studies an impressive consistency of response across many different behavioral measures, with a particularly strong result on cognitive rigidity, and impressively, the apparent normalization of some behaviors. With these results in hand, we are already putting next steps in place for this program.”
Professor Offen, PhD, commented “In light of our recent clinical studies providing promising evidences for safety and efficacy of NurOwn™ in ALS patients, the outstanding effect of these cells in this pre-clinical model highlights the platform’s potential as a treatment for autism as well.”
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. 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.
Tony Fiorino, MD, PhD
Chief Executive Officer
BrainStorm Cell Therapeutics Inc.
Phone: (201) 488-0460
LifeSci Advisors, LLC
Phone: (646) 597-6979