BrainStorm Enters Into Agreement with FDA Specialist for the Development of ALS Human Clinical Trial Protocol in the USA

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)-- 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.

About NurOwn™

BrainStorm’s core technology, NurOwn™, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center at the Tel-Aviv University.

The NurOwn™ technology processes adult human Mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many cell types. The research team is among the first to have successfully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF) by means of a specific differentiation-inducing culture medium.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. For more information, visit the company’s website at www.brainstorm-cell.com.

About PharmaNet

PharmaNet Development Group, Inc., an inVentiv Health Company and a recognized leader of global drug development services to the pharmaceutical, biotechnology, generic drug, and medical device industries, provides comprehensive capabilities in Phase I-IV clinical development, bio-analytical and bioequivalence services, regulatory, staffing, and therapeutic solutions. For the applied knowledge and intelligent solutions needed to accelerate drug development programs of all sizes around the world, PharmaNet works for you. For more information, please visit www.PharmaNet.com.

SafeHarbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.



CONTACT:

Company Contact:
BrainStorm Cell Therapeutics
Adrian Harel, Ph.D., COO and Acting CEO
+972-3-9236384
[email protected]

KEYWORDS:   United States  North America  Massachusetts  New York  Middle East  Israel

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Genetics  Oncology  Pharmaceutical  Research  FDA  Science

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