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BrainStorm, PharmaNet in ALS Pact

PharmaNet to assist with IND protocol

BrainStorm Cell Therapeutics has signed an agreement with PharmaNet LLC, a unit of inVentiv Health Co., to assist in the IND protocol development for the submission of BrainStorm’s NurOwn clinical trials in ALS patients. The drug was granted Orphan Drug Designation by the FDA as treatment for ALS.

Dr. Joyce L. Frey-Vasconcells will be leading the efforts on behalf of PharmaNet. She currently serves as 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 chief executive officer 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 U.S. that include Professor Robert Brown of the University of Massachusetts and Professor Merit Cudkowicz of Massachusetts General Hospital.”

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