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FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorm’s Phase 2 ALS Trial

NEW YORK, NY and PETACH TIKVAH, Israel /ACCESSWIRE / August 18, 2014 / BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Mayo Clinic Human Cellular Therapy Laboratory in Rochester, Minn. for production of NurOwn™, BrainStorm’s proprietary autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF). BrainStorm will continue working with the Mayo clinical team to complete the necessary steps to allow the site to begin enrolling subjects into its ongoing phase 2 study of NurOwn™, which is designed to evaluate the safety and efficacy of the transplantation of or NurOwn™ in patients with Amyotrophic Lateral Sclerosis (ALS).

Last month, BrainStorm submitted to the FDA the results of three pilot manufacturing runs performed at the Mayo Clinic, each of which resulted in the production of NurOwn cells that meet the final product release testing acceptance criteria. Upon activation, and subject to Institutional Review Board approval, the Mayo Clinic will become the third and final site enrolling subjects into Brainstorm’s ongoing ALS clinical trial. Earlier in 2014, both Massachusetts General Hospital (MGH) in Boston and the University of Massachusetts Memorial (UMass) Hospital in Worcester, Mass. began enrolling subjects in the study. The Dana-Farber Cancer Institute's Connell O'Reilly Cell Manipulation Core Facility manufactures NurOwn for these two clinical sites.

Dr. Yossef Levy, BrainStorm’s Vice President of Cell Production, commented, “This marks the completion of our second successful technology transfer process, and we acknowledge the hard work and dedication of the entire team at the Mayo Clinic in achieving this important milestone.”

BrainStorm’s Chief Executive Officer, Dr. Tony Fiorino, added, "I applaud the diligence and commitment of both the BrainStorm and Mayo Clinic teams in successfully completing this technology transfer. We are looking forward to the Mayo Clinic joining our Massachusetts’ sites in enrolling subjects into this important study."

BrainStorm’s phase 2 trial is a randomized, double-blind, placebo-controlled multi-center study designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF or NurOwn(TM)) in 48 ALS patients. The NurOwn cells will be administered via combined intramuscular and intrathecal injection. Patients will be followed monthly for approximately three months before and six months following transplantation. The primary objective of the study is to assess the safety and tolerability of a single administration of NurOwn. Secondary endpoints include changes in ALS Functional Rating Scale (ALS-FRS), Slow Vital Capacity (SVC) and muscle strength. For further details, please go to http://1.usa.gov/1l5XWkW.

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.


BrainStorm Cell Therapeutics Inc. (BCLI)

Tony Fiorino, MD, PhD

Chief Executive Officer

Phone: (646) 666-3188


US Investor Contact

LifeSci Advisors, LLC

Michael Rice

Phone: (646) 597-6979


SOURCE: BrainStorm Cell Therapeutics Inc.