NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--
BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has launched its activities in the US in preparation for its Phase IIa multi-center clinical trial, with the initiation of the NurOwn technology transfer process at the Dana Farber Cancer Institute (DFCI). DFCIs Connell and O'Reilly Cell Manipulation Core Facility will produce NurOwn in its cGMP-compliant clean room facilities for the MGH and UMass Hospital clinical sites. The third clinical site in the trial, Mayo Clinic, will produce NurOwn at its own cleanroom facility.
We are very pleased with the progress we are making at DFCI, this being the final step for submission of the Company's IND application to the US FDA, commented Mr. Chaim Lebovits, BrainStorms President.
The Cell Manipulation Core Facility (CMCF) at Dana-Farber Cancer Institute (DFCI) is a manufacturing facility that produces safe and effective novel cellular component therapy that meets all regulatory guidelines for clinical use and also facilitates research to be translated from the bench to the bedside. All procedures are performed in environmentally controlled conditions according to current Good Manufacturing Practices (cGMP) for cell and tissue processing.
In 2012 BrainStorm successfully completed its first-in-man Phase I/II clinical study at Hadassah Medical Center in Jerusalem with 12 ALS patients, demonstrating initial indications of clinical benefit in six patients. BrainStorms Phase IIa dose-escalating trial at Hadassah is currently underway and the company will release the preliminary efficacy data at the conclusion of the trial.
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 companys website at http://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 BrainStorms 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 managements 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 Launches US Activities for Its Multi-Center ALS Clinical Trial