NEW YORK & PETACH TIKVAH, Israel -- (BUSINESS WIRE) -- BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has achieved a new breakthrough for commercialization of its stem cell therapy candidate, NurOwn. The company has developed a proprietary method for cryopreservation, or freezing, of cells, which will enable long-term storage, and production of repeat patient doses of NurOwn without the need for additional bone marrow aspirations.
“Cryopreservation will enable us to create a personalized NurOwn stem cell bank for each patient, for ongoing, repeat treatments,” commented Dr. Adrian Harel, BrainStorm’s CEO. “We will be in a position to produce repeat doses of NurOwn by thawing and processing the patients’ cryopreserved cells, and transporting these doses to medical centers for immediate transplantation.”
Cryopreservation of hematopoeitic (or blood cell-forming) stem cells for clinical use has been routinely performed for fifteen years. Cryopreservation of mesenchymal stem cells for clinical use is a more recent phenomenon, and is typically done in vapor phase nitrogen. At extreme, sub-zero temperatures, any biological activity, including the biochemical reactions that would cause cell death, is effectively stopped.
According to Harel: “Our unique method of expansion and differentiation of mesenchymal stem cells requires its own cryopreservation methodology. The company’s R&D team has been focused on this aspect of product development in recent months in order to be fully prepared for repeat dosing of ALS patients.”
BrainStorm is currently launching a Phase IIa combined treatment, dose-escalating dose 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, 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 human 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.