BrainStorm Submits Favorable Interim Safety Report for Second Group of Patients in Its Phase IIa Dose-Escalating Trial of NurOwn(TM) in ALS
NEW YORK, NY and PETACH TIKVAH, ISRAEL--(Marketwired - Aug 1, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has submitted a favorable safety report to the hospital Helsinki Committee (IRB) for the second group of patients in its ongoing Phase IIa ALS clinical trial at the Hadassah Medical Center in Jerusalem, Israel. The treatment was well tolerated and no serious adverse events were observed. The company will release the preliminary efficacy data at the conclusion of the trial.
In this Phase IIa dose-escalating trial, currently underway at Hadassah under the direction of Principal Investigator Professor Dimitrios Karussis, 12 ALS patients are receiving combined intramuscular (IM) and intrathecal (IT) administration of NurOwn™ cells, in three cohorts, with increasing doses. The study participants will be monitored for six months following transplantation to evaluate the safety, tolerability and preliminary efficacy of NurOwn.
"This second group of patients received 50% more NurOwn cells than the first group in this trial," explained Professor Karussis. "Given the fact that they were treated both IM and IT, they received significantly more cells than in the previous Phase I study completed in our clinic," he added.
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.
