NEW YORK, PETACH TIKVA, Israel and BOSTON, July 2, 2018 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has contracted with the Connell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute (Dana-Farber) as a second U.S. manufacturing site to supply NurOwn® for the company's ongoing randomized, double-blind, multi-dose Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS) as well as other potential indications.
"We are pleased to announce a second partnership with Dana-Farber for the manufacturing of NurOwn," said Chaim Lebovits, president and CEO of BrainStorm. "Dana Farber is a world-renowned institution with decades of experience in stem cell transplantation. Its strong capabilities in this area and proven track record in the manufacture of NurOwn in the phase 2 trial, make it an ideal partner as we advance our Phase 3 trial to completion."
"We are pleased to support this important clinical trial. ALS is a devastating disease with no effective therapies. Our participation will allow more rapid patient accrual and will lead to earlier completion of the study," said Jerome Ritz, MD, Executive Director of the Connell and O'Reilly Families Cell Manipulation Core Facility.
In partnering with Dana-Farber for the manufacturing of NurOwn, BrainStorm has secured an additional facility to enhance production for the ongoing pivotal Phase 3 clinical trial, and to support manufacturing capacity for additional clinical indications.
BrainStorm is also pleased to update that CMC activities at City of Hope and enrollment in all six U.S. clinical sites are proceeding well. The first meeting of the Phase 3 Data and Safety Monitoring Board (DSMB) is expected by the end of August 2018 and Brainstorm will provide an update thereafter.
The Phase 3 trial is designed to enroll 200 patients with ALS, and is being conducted at six leading ALS clinical sites in the U.S. The primary outcome measure is the ALSFR-S score responder analysis. For more information, please refer to www.clinicaltrials.gov, using the NCT identifier NCT03280056.
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.
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BrainStorm Cell Therapeutics Inc.
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SOURCE BrainStorm Cell Therapeutics Inc.