BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the University of Massachusetts (UMass) Memorial Medical Center in Worcester, MA will begin enrolling patients into the Company’s randomized, double-bling placebo-controlled phase 2 clinical trial in Amyotrophic Lateral Sclerosis (ALS). UMass Memorial is the second site to become active of the three sites participating in this trial. The other two clinical sites participating in the multi-center trial are Massachusetts General Hospital (MGH), which began enrolling patients into the trial last month, and the Mayo Clinic, which is expected to become active in the third quarter of 2014. The Dana Farber Cancer Institute's Connell and O'Reilly Cell Manipulation Core Facility will manufacture NurOwn™ cells for MGH and UMass Memorial.
The principal investigator at UMass Memorial is Professor Robert H. Brown Jr., DPhil, MD, Chair of the Department of Neurology and renowned for his groundbreaking basic and clinical research on neurodegenerative and neuromuscular diseases. Professor Brown commented, "The pilot data from the first NurOwn trials are encouraging; we are delighted to participate in the follow-up study, an important next step in developing stem cell therapy for ALS. We are hopeful that the early signs of benefit will be repeated in this larger study."
Tony Fiorino, MD, PhD, CEO of BrainStorm, stated, “We are thrilled to welcome UMass as the second active site in this important study. Professor Brown brings an incredible amount of scientific expertise and clinical experience in ALS to this study, and we are grateful for his participation. We acknowledge the hard work for the entire UMass team in preparing for this moment look forward to continuing to work with them as the trial progresses.”
The ongoing Phase II trial is a randomized, double-blind, placebo controlled multi-center study designed to evaluate the safety and efficacy of NurOwn™ in 48 ALS patients. The primary endpoint of the study is the safety of intrathecal and intramuscular administration of NurOwn™. Secondary endpoints include change in the ALS Functional Rating Scale (ALSFRS) and change in slow vital capacity (SVC). For further information, go to www.clinicaltrials.gov.
About UMass Memorial
UMass Memorial Medical Center is the advanced tertiary care referral center for Central New England. The Medical Center offers a full complement of sophisticated technology and support services necessary to provide the region with specialists renowned for their work in areas such as cardiology, cancer, diabetes and orthopedics. To learn more about UMass Memorial, please visit www.umassmemorial.org.
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.
Tony Fiorino, MD, PhD
Chief Executive Officer
US Investor Contact
LifeSci Advisors, LLC
SOURCE: BrainStorm Cell Therapeutics