Leading adult stem cell technology developer BrainStorm Cell Therapeutics announced it has signed a memorandum of understanding (MOU) with San Francisco Bay Area-based contract research organization (CRO) PRC Clinical, in anticipation of BrainCell’s planned Phase II multicenter ALS clinical trial in the U.S.
BrainStorm chose PRC to manage its upcoming trial based on the organization’s comprehensive scope of support services, its experience with both orphan drug trials and neurological disease (specifically ALS), and its cutting-edge monitoring and management technologies.
“PRC Clinical is delighted to have been selected as the CRO for this trial, and we are committed to providing BrainStorm’s clinical development program with the highest quality management and data,” said PRC Clinical President and CEO Curtis Head.
Currently, BrainStorm is conducting a Phase IIa dose-escalating trial involving 12 ALS patients at the Hadassah Medical Center, located in Jerusalem, Israel. BrainStorm plans to launch a Phase II multicenter trial at the end of 2013 at three leading U.S. institutions, pending approval from the FDA.
BrainStorm Cell Therapeutics is a biotechnology company focused on developing first-of-its-kind adult stem cell therapies – derived from autologous bone marrow cells – to treat neurodegenerative diseases. BrainStorm holds the rights to develop and commercialize its NurOwn technology through an exclusive global licensing agreement with Tel Aviv University technology transfer company Ramot.
For more information, visit www.brainstorm-cell.com
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