HACKENSACK, N.J. and PETACH TIKVAH, Israel, March 1, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that is has signed a Memorandum of Understanding (MOU) with The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center (Ichilov Hospital) to explore the possibility of making NurOwn® available to Amyotrophic Lateral Sclerosis (ALS) patients under the provisions of Hospital Exemption regulation. The MOU also covers the participation of Tel Aviv Sourasky Medical Center in the planned Phase 3 trial that will investigate NurOwn in ALS.
The MOU sets forth the basic terms under which Brainstorm and Tel Aviv Sourasky Medical Center would work together to submit an application to the Israeli Ministry of Health that will allow patient access to NurOwn and is subject to a definitive agreement. The agreement is expected to be formalized in the first half of 2017.
"We are pleased to be working with Tel Aviv Sourasky Medical Center and look forward to putting a definitive agreement in place," said Chaim Lebovits, President and CEO of BrainStorm. "We believe that NurOwn meets the requirements to be a Hospital Exempt product and, if our application is successful, we could potentially make the product available to patients prior to obtaining formal licensure."
"Tel Aviv Sourasky Medical Center and BrainStorm have a joint interest in developing a path to bring advanced therapies to patients," said Professor Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We hope our combined efforts will leverage BrainStorm's technology to provide a new and innovative treatment option for our ALS patients."
About Hospital Exemption
The Israeli Ministry of Health (MoH) has recently adopted a policy that was developed in Europe in regards to advanced medical therapies, under which a Hospital Exemption (HE) Regulation was put in place. The new MoH guidelines, which are similar to the HE rules applied in the European Union, require Brainstorm Cell Therapeutics to partner with a local medical center in order to apply for HE.
About Tel Aviv Sourasky Medical Center
Tel Aviv Sourasky Medical Center (Ichilov) is the second largest and one of the most progressive full-service healthcare treatment and research institutions in Israel. The Medical Center draws patients from throughout the world for specialty care and routine procedures, designed specifically for the needs of international patients. Medical Center physicians integrate their clinical care with research on a daily basis. The Medical Center is the leading hospital in Israel in the number of research projects conducted. Each year, hundreds of research studies, both basic science and clinical, are conducted within the Medical Center's walls, in search of new medical understanding and to develop new diagnostic and treatment modalities. For more information, refer to http://www.tasmc.org.il/sites/en/About/Pages/About.aspx.
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 approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.
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.
Chief Operating Officer
BrainStorm Cell Therapeutics Inc.
LifeSci Advisors, LLC
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SOURCE BrainStorm Cell Therapeutics Inc.