BrainStorm Cell Therapeutics Reviews 3 Quarters of 2011 Achievements
November 10, 2011 8:46 AM
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a developer of adult stem cell technologies and therapeutics, today provided a review of recent accomplishments for shareholders and investors.
Since the beginning of the Phase I/II clinical trial for BrainStorm's autologous adult stem cell therapy at the Hadassah Medical Center, significant progress has been made towards achieving the goals of enrolling and treating patients with amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease.
Company's most recent achievements are:
In September of 2011 BrainStorm received notice from Israel's Office of the Chief Scientist (OCS) of its commitment to grant the Company's Israeli subsidiary approximately $1.1 million (NIS 3.8 million) in accordance with OCS requirements. The OCS has supported BrainStorm since 2007, providing grants of approximately $2,400,000 to date including this latest award.
In July 2011 BrainStorm entered into a Memorandum of Understating with Massachusetts General Hospital and the University of Massachusetts Medical School in anticipation of applying for FDA approval to begin ALS human clinical trials in the United States. The parties agreed to take initial preparatory steps for the collaboration, including developing a protocol for the ALS human clinical trials. The University of Massachusetts Medical School team will be led by Professor Robert H. Brown, MD, DPhil., Chair of the Neurological Department at University of Massachusetts Medical School. Professor Brown is a leading expert in neuromuscular genetics and is world renowned for his expertise in ALS.
BrainStorm also 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 who 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 CBER is currently serving as the Executive Director of PharmaNet Consulting.
In June 2011 BrainStorm initiated its Phase I/II clinical trial with its proprietary NurOwn™ treatment for patients with ALS at the Hadassah Medical Organization. BrainStorm is the first company to receive approval from the Israeli Ministry of Health (MOH) for a differentiated stem cell-based therapy. An interim safety report for the first four patients from the Hadassah Medical Center is expected in the first quarter of 2012.
In March 2011 Andrew H. Card, Jr., joined the Company's Business Advisory Board. Mr. Card was the second-longest serving White House Chief of Staff, appointed in the presidential administration of George W. Bush. The appointment of Mr. Card adds to the list of prominent members of the Company's Business Advisory Board, including: Dr. Jacob Frenkel, Harvey Krueger, and Rasheda Ali, daughter of former World Heavyweight Champion Muhammad Ali who suffers from Parkinson's disease.
In February 2011 BrainStorm entered into securities purchase agreements with certain institutional and other investors in connection with a private placement financing in reliance upon Regulation S. This transaction closed on February 28, 2011, and the Company received gross proceeds of approximately $3.6 million. The Company also issued warrants to the investors in the financing which were partially exercised for an additional $265,000.
BrainStorm was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the Company's NurOwn™ autologous adult stem cell product candidate for the treatment of ALS. This designation affords the Company seven years of marketing exclusivity for NurOwn™ upon regulatory approval, as well as the opportunity to apply for grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA's application user fee.
In January 2011 BrainStorm appointed an experienced drug developer, Adrian Harel, Ph.D., as the Company's Acting Chief Executive Officer. Dr. Harel brings to the Company a remarkable record of professional achievement and knowledge in drug development and manufacturing in addition to building and managing highly successful biotechnology companies.
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 a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson's Research, 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 other 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 astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF). The ability to induce differentiation into astrocyte-like cells along with intramuscular or intrathecal (or other) delivery makes NurOwn™ technology highly attractive for treating ALS and Parkinson's disease as well as MS and spinal cord injury.
BrainStorm's stem cell therapy provides human mesenchymal stromal cells induced to differentiate into astrocyte-like cells secreting neurotrophic factors by means of a specific differentiation-inducing culture medium.
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. develops 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.
Safe Harbor 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.
BrainStorm Cell Therapeutics
Adrian Harel, Ph.D., Acting CEO
+972-3-9236384
aharel@brainstorm-cell.com







