NEW YORK, NEW YORK and PETACH TIKVAH, ISRAEL--(Marketwired - June 26, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has signed a Memorandum of Understanding (MOU) with PRC Clinical™, a Contract Research Organization (CRO) based in the San Francisco Bay Area, in anticipation of its planned Phase II multi-center ALS clinical trial in the United States.
"We chose PRC Clinical to manage our upcoming US-based trial based on their comprehensive range of support services, their experience with both orphan drug trials and neurological disease, specifically ALS, and their use of state-of-the-art monitoring and management technologies," said Alon Natanson, BrainStorm's CEO.
"PRC Clinical is delighted to have been selected as the CRO for this trial and we are committed to providing BrainStorm's clinical development program with the highest quality management and data," commented Curtis Head, President and CEO of PRC Clinical.
BrainStorm is currently conducting a Phase IIa dose-escalating trial with 12 ALS patients at the Hadassah Medical Center in Jerusalem, Israel. The company anticipates launching a Phase II multi-center trial at three leading institutions in the United States towards the end of 2013, pending FDA approval.
About PRC Clinical™
PRC Clinical™ offers an array of clinical management services focused on helping companies improve trial efficiency. Supporting Phase I-IV clinical studies for virtual, small and mid-size pharmaceutical, biotechnology and medical device companies, their service offerings range from protocol development, project management, and regional monitoring to clinical data management and clinical payment services. For more information, please visit www.prcclinical.com.
About BrainStorm Cell Therapeutics
BrainStorm Cell Therapeutics 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.