BrainStorm Establishes Safety of Repeat Doses of NurOwn in Mice; Pre-clinical Study Conducted at GLP-compliant Harlan Laboratories
NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--Jan 10, 2013 - BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that it has successfully completed a 12-week repeat dose toxicity study with its NurOwn cells in mice. The company believes that the positive data from the study will support its efforts to obtain approval for a future repeat dose clinical study in ALS patients. The study was conducted at Harlan Israel's laboratories, according to GLP (Good Laboratory Practice) standards of the FDA. The study protocol was approved by the Israeli Ministry of Health.
“We believe that repeat dosing is the key to the long-term clinical efficacy of NurOwn and we are anxious to begin testing in ALS patients. Our proprietary cryopreservation protocol will enable us to do so without having to perform repeat bone marrow aspirations for each dose,” commented Dr. Adrian Harel, BrainStorm's CEO.
In the study, the animals received up to three intramuscular injections of NurOwn, produced from cryopreserved, or frozen, cells at concentrations 50–100 times the currently administered clinical trial dose. The treatment was well tolerated, and no adverse clinical effects were observed. Analyses included cytokine profile assays, clinical pathology, necropsy and macroscopic examination, as well as histopathological examinations.
BrainStorm is currently launching a Phase IIa combined treatment, dose-escalating trial of its NurOwn cell therapy candidate in ALS patients at the Hadassah Medical Center in Jerusalem. The company was recently fast-tracked by the Israeli Ministry of Health after reporting positive safety data for 12 patients in a Phase I/II trial.
BrainStorm is planning to expand its ALS clinical development to the United States in 2013, pending FDA approval. Towards that goal, the Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS clinical trials at these institutions.
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.
Posted: January 2013