Brainstorm Cell Therapeutics Inc. announced that the Israeli Ministry of Health has fast-tracked its current Phase I/II ALS safety trial to a Phase IIa dose-escalating trial, significantly expediting the company's clinical development program and saving valuable time. The trial, which will evaluate the safety and preliminary efficacy of BrainStorm's NurOwn stem cell therapy candidate, will be launched immediately at the Hadassah Medical Center in Jerusalem. The Ministry of Health approved acceleration to a Phase IIa trial based on evaluation of only 12 of the initial cohort of 24 patients in the company's Phase I/II trial at Hadassah.

In the Phase IIa trial, the second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be followed for three to six months after transplantation. BrainStorm has been conducting a Phase I/II clinical trial in ALS patients at the Hadassah Medical Center in Jerusalem since June 2011, and plans to launch the Phase IIa study immediately.

The company is also planning to expand its 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 human clinical trials at these institutions.