First Patient Begins Treatment in BrainStorm's Phase IIa Trial for ALS
NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the first patient began treatment in the Company's Phase IIa dose-escalating clinical trial for ALS. The trial, which will evaluate the safety and preliminary efficacy of BrainStorm's NurOwn stem cell therapy candidate, is being conducted at the Hadassah Medical Center in Jerusalem.
In the Phase IIa trial, three groups of four patients will receive combined intramuscular and intrathecal administration of NurOwn cells, in increasing doses. The first cohort of four patients is expected to complete treatment by the end of April 2013. The trial participants will be monitored for three to six months following transplantation.
"We are excited to be treating the first patient in this trial, which will build on the excellent safety profile and encouraging positive results from our Phase I/II study," commented Alon Natanson, BrainStorm's CEO.
"This trial will provide valuable data not only on the safety of NurOwn in ALS patients, but also on the ability of different dosing levels to provide clinical benefit," added Prof. Dani Offen, the Company's Chief Scientific Advisor.
Israel's Ministry of Health recently approved BrainStorm's acceleration to a Phase IIa trial following the positive safety evaluation of the first 12 patients in the company's recent Phase I/II trial at Hadassah. A description of the trial can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01777646?term=NCT01777646&rank=1.
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 athttp://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.
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