BrainStorm Cell Therapeutics Inc., a developer of adult stem cell technologies and central nervous system (CNS) therapeutics, has signed an agreement with PharmaNet LLC, a global drug development services provider, to help Brainstorm develop protocol and IND file for submission to the U.S. FDA for approval of BrainStorm’s amyotrophic lateral sclerosis (ALS) in human clinical trials.
The FDA has already granted Orphan Drug Designation for BrainStorm’s NurOwn™ treatment for ALS, and the company’s deal with PharmaNet brings the company one step closer to receiving FDA approval for human clinical trials in the United States.
Dr. Joyce L. Frey-Vasconcells will head up the efforts on behalf of PharmaNet, bringing to the table years of expertise in cell therapy, gene therapy, as well as experience working at the FDA as the deputy director for the Office of Cellular, Tissue and Gene Therapies with the Center of Biologics Evaluation and Research. Dr. Frey-Vasconcells currently serves as the executive director of PharmaNet Consulting.
“Dr. Frey-Vasconcells brings a wealth of knowledge to the development of our protocol and IND file for submission to the FDA,” Dr. Adrian Harel acting CEO of BrainStorm stated in the press release. “I am extremely pleased to have her join our expert team.”
NurOwn has demonstrated ability to process adult human mesenchymal stem cells found in bone marrow; these cells are capable of self-renewal, as well as differentiation into many cell types, making them a focus of regenerative therapy.
For more information visit www.PharmaNet.com or www.brainstorm-cell.com
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