BrainStorm Cell Therapeutics Inc. (BCLI.PK or BCLI.QB formerly BCLI.OB), a leading developer of adult stem cell technologies and therapeutics, today provided a review of recent accomplishments for shareholders and investors.
Since the beginning of 2011, BrainStorm has made significant progress towards achieving its goal of enrolling patients with amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease, in a Phase I/II clinical trial for BrainStorm’s autologous adult stem cell therapy (NurOwn™). BrainStorm anticipates that it will be able to complete patient enrollment and begin the Phase I/II clinical trial during the first half of 2011 at the Hadassah Medical Center.
While the Company is current on all its filings and therefore eligible to be quoted on the Over-the-Counter Bulletin Board (“OTCBB”), due to issues related to the market makers that quote on the OTCBB, the Company, together with hundreds of other companies, is now being quoted on the Pink Sheets and on the OTC.QB. The Company did find a market maker that is willing to file the relevant filings required in order for the Company to be approved by the Financial Industry Regulatory Authority ("FINRA") and reinstated for trade on the OTCBB. Until such forms are filed and approved by FINRA, the Company is being traded on the Pink Sheets at BCLI.PK. Once approved by FINRA, the Company will make an announcement.
The confusion caused by the above mentioned matter has potentially affected the exposure of the Company's most recent press releases detailing its recent achievements. Therefore for those shareholders that follow the Company on stock quote providers, such as Yahoo and Google Finance, which did not reflect our listing change, below is a summary of BrainStorm’s achievements during the first three months of 2011:
- The second-longest serving White House Chief of Staff, Andrew H. Card, Jr., who was appointed in the presidential administration of George W. Bush, joined the Company's Business Advisory Board. The appointment of Mr. Card adds to the list of prominent members of the Company’s Business Advisory Board, including: Dr. Jacob Frenkel, Chairman of JPMorgan Chase International and a member of the JPMorgan Chase (NYSE: JPM) Executive Committee and its International Council; Harvey Krueger, Vice Chairman of Barclays Capital and Chairman Emeritus of Lehman Brothers, Inc.; and Rasheda Ali, author and daughter of former three-times World Heavyweight Champion Muhammad Ali who suffers from Parkinson’s disease.
- 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, and, if exercised in full, would bring in an additional $8.2 million in cash to the Company.
- 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.
- Preclinical results published in Stem Cell Reviews and Reports demonstrated that BrainStorm’s NurOwn™ stem cell technology shows promise for treating sciatic nerve injury. Intramuscular transplantation of autologous, astrocyte-like cells that produce and secrete neurotrophic factors (NTFs), representing the company’s NurOwn™ technology platform, preserved motor function, significantly inhibited the degeneration of the neuromuscular junctions (NMJs), and preserved the myelinated motor axons in an animal sciatic nerve injury model.
- BrainStorm appointed a highly experienced drug developer, Adrian Harel, Ph.D., as the Company’s Chief Operating Officer and Acting Chief Executive Officer. Dr. Harel brings to the Company a remarkable record of professional achievement and experience in drug development and manufacturing in addition to building and managing highly successful biotechnology companies.
“We are very excited about the opportunities ahead for BrainStorm, as we are poised to enter Phase I/II clinical development with our NurOwn™ product candidate, which is designed to harness the patient’s own regenerative mechanisms to treat ALS and other neurodegenerative diseases,” said Chaim Lebovits, President of BrainStorm. “As evidenced by our recent accomplishments, we now have the right people, resources, and strategy in place to leverage our NurOwn™ platform and we look forward to reporting to you on our progress with validation of sterility tests requested by the Israeli Ministry of Health (MOH) and the screening of patients for the trial.”
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 (FMRC) 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 contains 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. is an emerging 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.
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
MD Becker Partners LLC
Michael Becker, Senior Partner