BrainStorm Cell Therapeutics Inc. (BCLI.OB), an innovative developer of adult stem cell technologies and CNS therapeutics, announced today that it has signed an agreement with PharmaNet LLC, an inVentiv Health Company, to assist in the development of the protocol and IND file for submission to the FDA for approval of BrainStorm's ALS human clinical trials in the United States.
Dr. Joyce L. Frey-Vasconcells will be leading the efforts on behalf of PharmaNet. Dr. Frey-Vasconcells has expertise in cell therapy and gene therapy as well as tumor vaccines, tissues and combination products. She has more than 12 years experience working at the FDA where she served as the Deputy Director, Office of Cellular, Tissue and Gene Therapies with the Center of Biologics Evaluation and Research and is currently serving as the Executive Director of PharmaNet Consulting.
"The agreement with PharmaNet brings us one step closer to obtaining FDA approval for our human clinical trials in the United States", said Dr. Adrian Harel acting CEO of BrainStorm. "Dr. Frey-Vasconcells brings a wealth of knowledge to the development of our protocol and IND file for submission to the FDA. I am extremely pleased to have her join our expert team. Dr. Frey-Vasconcells will work alongside our team of experts in the United States that include Professor Robert Brown of the University of Massachusetts and Professor Merit Cudkowicz of Massachusetts General Hospital."
BrainStorm was granted FDA Orphan Drug Designation for its NurOwn™ treatment for ALS. The Company has recently announced that it signed an MOU with Massachusetts General Hospital and the University of Massachusetts. The collaboration with be led Professor Merit Cudkowicz of Massachusetts General Hospital and by Professor Robert Brown of the University of Massachusetts Medical School.
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