BrainStorm Cell Therapeutics (OTCQB:BCLI): Initiates US Activities for ALS Clinical Trial

BrainStorm Cell Therapeutics (OTCQB:BCLI) on Tuesday, October 01, 2013 announced that it has initiated activities in the United States towards preparation for its Phase IIa multi-center clinical study. This includes initiation of the technology transfer process of the company’s proprietary NurOwn to the DFCI (Dana Farber Cancer Institute).

Connell and O’Reilly Cell Manipulation Core Facility at DFCI will then engage in production of NurOwn for the UMass Memorial Medical Center and Massachusetts General Hospital clinical sites. This facility at DFCI is current Good Manufacturing Practices (cGMP)-compliant. The Cell Manipulation Core Facility is a manufacturing facility for the production of safe and effective cellular component therapy in line with underlying regulatory guidelines for clinical use. The facility also extends the support research implementation from bench to the bedside.

The third site for the proposed clinical study – the Mayo Clinic will produce NurOwn at its own clean room facility. Utmost care will be exercised to perform all the procedures in environmentally controlled conditions for cell and tissue processing in adherence to the cGMP.

The President of BrainStorm Cell Therapeutics (OTCQB: BCLI), Mr. ChaimLebovits mentioned that the company is making progress at DFCI and this marks the final step towards submission of the company’s Investigational New Drug (IND) Application to the United States Food and Drug Administration (USFDA).

The company has successfully completed its Phase I and II clinical study at the Hadassah Medical Center, Jerusalem with twelve Amyotrophic Lateral Sclerosis (ALS) patients and demonstrated initial indications of clinical benefit in six patients. The Phase IIa dose escalation trial at this facility is currently in progress and the preliminary study data will be released at the conclusion of the trial.

Company Brief

A development stage biotechnology company, BrainStorm Cell Therapeutics (OTCQB: BCLI), engages in the development of first of its kind adult stem cell therapies for the treatment of neurodegenerative diseases.

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