Brainstorm Cell Therapeutics Inc. announced 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 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. 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.