BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, has signed a memorandum of understanding (MoU) with PRC Clinical, a Contract Research Organization (CRO) based in the San Francisco Bay Area, in anticipation of its planned phase II multi-centre ALS clinical trial in the United States.

“We chose PRC Clinical to manage our upcoming US-based trial based on their comprehensive range of support services, their experience with both orphan drug trials and neurological disease, specifically ALS, and their use of state-of-the-art monitoring and management technologies,” said Alon Natanson, BrainStorm’s CEO.

“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,” commented Curtis Head, president and CEO of PRC Clinical.

BrainStorm is currently conducting a phase IIa dose-escalating trial with 12 ALS patients at the Hadassah Medical Centre in Jerusalem, Israel. The company anticipates launching a phase II multi-centre trial at three leading institutions in the United States towards the end of 2013, pending FDA approval.

PRC Clinical offers an array of clinical management services focused on helping companies improve trial efficiency. Supporting Phase I-IV clinical studies for virtual, small and mid-size pharmaceutical, biotechnology and medical device companies, their service offerings range from protocol development, project management, and regional monitoring to clinical data management and clinical payment services.

BrainStorm Cell Therapeutics 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.