BrainStorm Cell Announces Agreement With University of California, Irvine Medical Center To Participate In Phase III Trial Of NurOwn In ALS
HACKENSACK, N.J. and PETACH TIKVA, Israel, July 25, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has signed a definitive agreement with the University of California Irvine Medical Center (UCI) to enroll patients in the planned Phase 3 clinical trial of NurOwn® in amyotrophic lateral sclerosis (ALS), pending FDA and Institutional Review Board approvals. Dr. Namita Goyal has agreed to participate as Principal Investigator at UCI.
UCI has become the third medical center to enter into a clinical trial agreement with BrainStorm to enroll patients in the planned Phase 3 study for NurOwn. Mass. General Hospital (MGH) and California Pacific Medical Center (CPMC) have both agreed to participate in the trial and will be enrolling patients, as announced last week.
"We are privileged to have UCI and Dr. Goyal join our pivotal Phase 3 study of NurOwn," said Chaim Lebovits, President and Chief Executive Officer. "Adding UCI as an enrolling center with Dr. Goyal as Principal Investigator will make the treatment more accessible to patients in California, and we welcome the opportunity to work with this prestigious institution."
"NurOwn is a very promising treatment with compelling Phase 2 data in patients with ALS; we look forward to further advancing it in clinical development and confirming the therapeutic benefit with Brainstorm," said Dr. Namita Goyal, Director, ALS Clinic, Neuromuscular Medicine Fellowship and Neuromuscular Diagnostic Laboratory, University of California, Irvine.
Namita Goyal, M.D. is an Associate Clinical Professor of Neurology in the Department of Neurology at the University of California, Irvine School of Medicine. She is a specialist in neuromuscular medicine, with board certifications in neurology, electrodiagnostic medicine and neuromuscular medicine. Dr. Goyal completed her residency in neurology at University of Chicago Medical Center, followed by a fellowship in clinical neurophysiology and neuromuscular disease at Harvard University'sMassachusetts General Hospital, where she also served as a neuromuscular clinician for several years. Dr. Goyal is currently a treating physician at UC Irvine, with a special focus on ALS, and has been the lead site investigator in several ALS clinical trials.
UCI is also part of the Alpha Stem Cells Clinics Network, which is funded by the California Institute for Regenerative Medicine (CIRM). The Alpha Stem Cells Clinics Network is specializing in delivering stem cell clinical trials to patients.
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 Business Officer
BrainStorm Cell Therapeutics Inc.
LifeSci Advisors, LLC
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