|By Marketwired .||
|July 11, 2014 07:08 AM EDT||
NEW YORK, NY and PETACH TIKVAH, ISRAEL -- (Marketwired) -- 07/11/14 -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today publication of an important preclinical study in the journal Clinical and Translational Medicine. This paper describes the safety of single and repeated intramuscular administration of NurOwn, the Company's proprietary mesenchymal stem cells that are induced to secrete a variety of neurotrophic factors. NurOwn is in clinical development for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has demonstrated efficacy in preclinical models of a variety of neurodegenerative diseases, including Parkinson's disease, Huntingon's disease and multiple sclerosis. The results published today are important because they establish that repeated doses of NurOwn are safe in mice and more specifically, that mice generate only minimal immune response after repeated exposure to NurOwn, which are human cells. These data will help support the use of multiple doses of NurOwn in future clinical trials.
One of the major goals of this study was to determine if normal mice develop an immune response to NurOwn after repeated exposures to the cells. The study assessed a variety of Th1 and Th2 cytokines in these mice, which have a normally functioning immune system, and observed only transient increases in interleukin (IL)-5, IL-6 and to a lesser extent IL-2, which returned to baseline within 24 hours after administration of NurOwn. Importantly, IL-4 and IL-10, which are key regulators of the humoral immune response, were undetectable before and after treatment. Thus, there was no substantial or durable immune response to NurOwn after two or three repeated administrations in mice, despite the fact that the cells were of human origin. In addition, the repeated administration of NurOwn was well-tolerated in these mice, with no evidence of systemic toxicity and minor irritation seen at the site of intramuscular administration.
Commenting on this publication, BrainStorm's CEO Tony Fiorino, MD, PhD, noted, "For the treatment of most neurodegenerative diseases, we expect that sustained benefit will require multiple doses of NurOwn. Thus we are pleased to see such a benign safety profile in this study, and in particular the lack of an immune response in these mice to repeated exposure to human cells. These observations match the excellent safety profile that has been observed clinically in two ALS patients who have received two doses of NurOwn at Hadassah Medical Center, under a Compassionate Use protocol approved by the Israeli Ministry of Health."
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.
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