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Results of NurOwn(TM) Clinical Trial Suggest Efficacy in ALS Patients
Data Indicate Initial Clinical Benefit in Overall Clinical and Respiratory Function
BrainStorm Cell Therapeutics ( OTCQB : BCLI ), a leading developer of adult stem cell technologies for neurodegenerative diseases, today reported some of the final results from a clinical study evaluating the company's NurOwn™ technology in 12 ALS patients. NurOwn is a proprietary, first-of-its-kind technology for the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into NeuroTrophic Factor (NTF)-secreting cells. The data were presented yesterday, Wednesday, March 20, 2013 during the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, California.
An oral and poster presentation were made in the Emerging Science Session by Principal Investigator Dimitrios Karussis, M.D., Ph.D., entitled, "Analysis of 12 Patients with Amyotrophic Lateral Sclerosis (ALS) Treated with Autologous Differentiated Mesenchymal Stem Cells: a Phase I/II Clinical Trial." Karussis reported a significantly slower decline in overall clinical and respiratory function, as measured by the ALS Functional Rating Score (ALSFRS-R) and Forced Vital Capacity (FVC) score respectively, in the six patients that received an intrathecal (IT) injection of the cells in the six months following treatment, as compared to the three months preceding treatment. The study concluded that in addition to establishing the safety of the treatment protocol, initial indications of clinical benefit were observed, which require further confirmation in additional trials. The company is currently conducting a Phase IIa dose-escalating trial pursuant to recent acceleration by the Israeli Ministry of Health.
"These encouraging results confirm the importance and therapeutic potential of NurOwn as a breakthrough treatment for patients with ALS," said Prof. Karussis, Head of the Neuroimmunology Laboratory, Department of Neurology, Hadassah Medical Center, Jerusalem. "Additionally, beyond its benefit in treating patients with ALS, NurOwn may have utility in the treatment of other severe neurodegenerative and neuroimmunological conditions including multiple sclerosis and Parkinson's disease."
"We are excited by these data and the potential of NurOwn to positively impact the lives of patients with ALS," said Alon Natanson, Chief Executive Officer of BrainStorm. "We look forward to continuing to advance this potentially important therapy. To that end, we have begun a Phase IIa dose-escalating trial at Hadassah and plan to launch a multi-center Phase II trial in the USA later this year in order to further validate the results that were presented today."
About NurOwn™NurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells (MSC) into specialized, neuron-supporting cells. These neuron-supporting cells (known as "MSC-NTF" cells) secrete neurotrophic, or nerve-growth, factors for PROTECTION of existing motor neurons, PROMOTION of motor neuron growth, and RE-ESTABLISHMENT of nerve-muscle interaction. The ability to differentiate mesenchymal stem cells into MSC-NTF cells, and confirmation of their activity and potency before transplantation, makes NurOwn a first-of-its-kind approach for treating neurodegenerative diseases. More information about NurOwn™ can be found at http://brainstorm-cell.com/index.php/science-a-technology/-nurown.
About ALSOne of the most common neuromuscular diseases worldwide, Amyotrophic lateral sclerosis (ALS), sometimes called Lou Gehrig's disease, is a rapidly progressive, invariably fatal neurological disease that attacks the nerve cells responsible for controlling voluntary muscles. As many as 30,000 people in the United States have ALS and an estimated 5,000 Americans are newly diagnosed each year. The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons. There is currently no cure available for ALS.
About BrainStorm Cell Therapeutics, Inc.BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, 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. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, 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 athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
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Introduction
Investor Presentation – March 2013BrainStorm Cell Therapeutics (OTC.QB: BCLI) is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS) and Parkinson’s Disease (PD).
NurOwn™, our proprietary, first-of-its-kind technology for the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into NeuroTrophic Factor (NTF)-secreting cells and their transplantation at or near the site of damage, offers the hope of conquering neurodegenerative diseases.
We are currently conducting a Phase IIa ALS clinical trial with NurOwn at the Hadassah University Medical Center in Jerusalem. In this safety and preliminary efficacy trial, 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts with increasing doses. The study participants will be followed for three to six months after transplantation.
The company also plans to begin a Phase II clinical trial in the USA in 2013, pending FDA approval.
In February 2011, NurOwn was granted Orphan Drug designation by the FDA. Over 20 publications in leading scientific journals demonstrating NurOwn's mechanism of action, pharmacology and in vivo efficacy have been published by the scientific team.
Mission
BrainStorm is developing autologous, adult stem cell therapies to treat a variety of debilitating neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's Disease), Parkinson's Disease (PD), and Multiple Sclerosis (MS).Our approach uses the patient's own bone marrow to generate specialized NeuroTrophic Factor (NTF)-secreting cells, which are then transplanted into the spine or muscles, to protect existing motor neurons, promote new motor neuron growth, and re-establish nerve-muscle interaction.We are committed to developing an effective treatment that will overcome the devastating effects of neurodegenerative disease.
Stem Cell Therapy
Stem Cell therapies are one of the most promising areas of medicine today.
The aim of cell therapy is to support and repair damaged tissues and organs by providing healthy stem cell transplants. Bone marrow stem cell transplants for replacement and restoration of the haemopoietic system (blood and lymph) of cancer patients have been successfully used for the past 20 years.
Stem cells are generally described as cells that are capable of both self-renewal and differentiation. Stem cells have the ability to undergo asymmetric division such that one of the two daughter cells retains the properties of the stem cell, while the other begins to differentiate into a more specialized cell type. Stem cells are therefore central to normal human growth and development and a potential source of new cells for the regeneration of diseased and damaged tissue.
BrainStorm is developing cellular therapeutics based on stem cell technologies. The medical benefits afforded by stem cell therapies offer hope to millions of patients suffering from many types of neuro-degenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, often referred to as Lou Gehrig's Disease), Parkinson’s disease (PD), and Multiple Sclerosis (MS).
Management Team
Chaim Lebovits President
Alon Natanson, MBA CEO
Adrian Harel, Ph.D. Director of R&D
Liat Sossover, CPA, MBA CFO
Prof. Eldad Melamed, M.D. Chief Medical Advisor
Prof. Daniel Offen, Ph.D.Chief Scientific Advisor
Our Partners
Our Partners
At BrainStorm we’re interested in exploring strategic partnerships that will further our clinical and technological goals. These academic and clinical collaborations with leading scientific and medical investigators, as well as technological alliances with biotechnology and pharmaceutical companies.
We're proud to be partnering today with a leading university medical center and an innovative technology company in the areas of clinical and technology development:
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Hadassah Medical Center, JerusalemSince June 2011, BrainStorm has been conducting a Phase I/II clinical trial in patients with ALS at Hadassah Medical Center in Jerusalem. The trial, headed by Prof. Dimitrios Karussis of the Department of Neurology, is designed to evaluate the safety and tolerability of NurOwn™.
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![](https://lh3.googleusercontent.com/blogger_img_proxy/AEn0k_tI4Ixo47fwxGKqFxI_puhbOfLnlceJU6orP0zceHwQ-YjpryH3WfjNRsIJ272hGGzZgz0SW1lyZuoiMLtPYJHoA6HVwtvnnHPUo87EDYUq9vmNHhSMS3cIweYAI-Wjmb9gdrOyq3-qiFC9SxZ2=s0-d) | Octane Biotech, Kingston, OntarioBrainStorm is collaborating with Octane Biotech to develop a proprietary bioreactor that will optimize the scale-up of the NurOwn production process. Using Octane’s Automated Cell & Tissue Engineering System (ACTES) technology, we are working on a customized bioreactor that will increase our NurOwn production capabilities and reduce both costs and time. |
- BrainStorm Cell Therapeutics Presents at the 11th International Conference on Alzheimer's and Parkinson's DiseaseMarketwire(Fri, Mar 8)
- ALS Crisis Of Conscience At FDA Spells Opportunity For Neuralstem, Brainstormat Seeking Alpha(Thu, Mar 7)
- Rasheda Ali on National and Local News: BrainStorm’s ALS Clinical Trial Results Exceeded ExpectationsBusiness Wire(Wed, Feb 27)
- BrainStorm to Present at the 8th Annual New York Stem Cell SummitBusiness Wire(Wed, Feb 13)
- BrainStorm Announces Private Equity Financing of $250,000 with Individual Private InvestorBusiness Wire(Mon, Feb 11)
- BRAINSTORM CELL THERAPEUTICS INC. Files SEC form 8-K, Unregistered Sale of Equity SecuritiesEDGAR Online(Fri, Feb 8)
- First Patient Begins Treatment in BrainStorm’s Phase IIa Trial for ALSBusiness Wire(Mon, Feb 4)
- BRAINSTORM CELL THERAPEUTICS INC. Files SEC form 8-K, Change in Directors or Principal Officers, Financial StatementsEDGAR Online(Mon, Jan 28)
- BrainStorm Cell Therapeutics Appoints Alon Natanson as Chief Executive OfficerBusiness Wire(Mon, Jan 28)
- BrainStorm’s CEO Issues Annual Letter to ShareholdersBusiness Wire(Wed, Jan 23)
- BrainStorm Establishes Safety of Repeat Doses of NurOwn in Mice; Pre-clinical Study Conducted at GLP-compliant Harlan LaboratoriesBusiness Wire(Thu, Jan 10)
- BrainStorm Achieves Important New Development for Commercialization of NurOwnBusiness Wire(Wed, Jan 9)
- BRAINSTORM CELL THERAPEUTICS INC. Files SEC form 8-K, Other Events, Financial Statements and ExhibitsEDGAR Online(Tue, Jan 8)
- BrainStorm's Clinical Trial is Fast-Tracked to Phase IIa, Representing a Major Milestone for the CompanyBusiness Wire(Mon, Jan 7)
- BrainStorm Announces New Shareholders Conference Call Date to Discuss Upcoming Positive DevelopmentsBusiness Wire(Thu, Jan 3)
Company Address
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Share Structure
Market Cap | 35.27M |
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Avg Volume (3 M) | 188,193 |
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52 Week High | $0.17 |
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52 Week Low | $0.38 | |
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Contact
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- You should consider the financial condition of the Profiled Company in your analysis by accessing such information from www.sec.gov or www.otcmarkets.com; if such financial information is unavailable from either one of these sites, the risk investment level of investing in any such Profiled Company will be increased.
- Many of the companies are subject to numerous risks particular to the industry that they engage in.
- We conduct no due diligence whatsoever regarding: (a) the Issuer; (b) the third party shareholder; and (c) the relationship, if any, between the third party shareholder and the Issuer;
- Our trading activities described above may cause: (a) significant volatility in the Issuer's; (b) price declines from our selling activities; (c) an unrealistic report of trading volume, without denoting publicly that we are the primary seller; (d) permit us to make substantial profits while we are disseminating profiles or information about the issuer, yet may result in a diminished value of the Profiled Company’s Securities.
- We conduct no due diligence on the press releases or profiles we receive from OTC Markets News Service or other publicly available source, nor do we conduct due diligence on any other information we disseminate to the public.
- Penny stocks are subject to the SEC's penny stock rules and subject broker-dealers to customer suitability rules and other requirements, which may lead to low volume in the securities and/or difficulties in selling the shares.
- We do not assume any responsibility for forward-looking statements nor do we assume any responsibility for updating forward-looking statements.
- Use of this information is at your own risk and is presented only on an “as is” basis – in other words, you must conduct your own analysis of the risks associated with use of the Information, including its accuracy or reliability.
- Many penny stocks are thinly traded, which may lead to difficulties in selling your securities and extreme price volatility.
- Penny stock companies are often subject to extreme regulatory oversight in the industry that they participate in.
- Penny stock companies are often subject to extreme competition and most frequently have less brand name recognition, operational and personnel resources, technical resources, capital resources, or financing sources.
- There is no “right time “to purchase or sell penny stocks or set of factors making it advisable to purchase a Profiled Company’s securities “now”, since at any time such stocks may be subject to price volatility, stock manipulation forces and other negative market forces.
- A Profiled Company may have negative signs on the otcmarkets.com website that indicate various risks of investing in that individual issuer, as follows: (i) “Limited Information” for companies with financial reporting problems, economic distress, or that are unwilling to file required reports with the Pink Sheets; (ii) “Pink Sheets – No Information”, which indicates companies that are unable or unwilling to provide disclosure to the public markets, to the SEC or the Pink Sheets; and (iii) “Caveat Emptor”, signifying “Buyer Beware” that there is a public interest concern associated with a company’s illegal spam campaign, questionable stock promotion, known investigation of a company’s fraudulent activity or its insiders, regulatory suspensions or disruptive corporate actions.
- The Issuer may be delinquent in its filings with the Securities and Exchange Commission or at otcmarkets.com, which you will be able to determine by accessing the websites at sec.gov or otcmarkets.com.
- The stock price and trading volume of any Issuer that we advertise may increase significantly as a result of our dissemination of the Information and then significantly decrease as a result of our or others selling significant or massive quantities of an Issuer;
- Many penny stock companies are subject to risks pertaining to the development stage nature of their business, including that they have failed to provide a proof of concept to their technology or business or their business plan has little if any merit whatsoever.
- Many penny stock companies are in need of financing, which they may be unable to obtain on favorable terms or at all.
- Our advertising activities may cause trading volume of a Profiled Company’s securities to temporarily increase by hundreds or thousands of percent, yet such trading volume may cease at any one time;
- Our advertising activities may cause trading volume in Issuers to materially increase, yet such trading volume may cease at any one time, especially if we cease disseminating Information about the Issuers, which will cause difficulties in selling your securities or may be an unrealistic indicator of interest in the Issuer’s securities.
- The Information has no predictive value whatsoever of the future stock price of the Profiled Company’s securities or its ability to be successful in its business objectives.
- Should the SEC determine that inadequate information or irregularities have occurred with a Penny Stock Issuer, they may issue a trading suspension, which will suspend trading in the Issuer’s securities and may for all intents and purposes permanently cease trading because broker-dealers may not accept trades in that particular Issuer’s securities.
- The press releases, issuer profiles and information we provide represent only a small amount of information regarding the Issuer, which is insufficient to formulate an investment decision; as such, that information should only be a starting point from which you conduct an in-depth investigation of the issuer from available public sources, such as www.sec.gov, otcmarkets.com, www.sec.gov, yahoofinance.com,www.google.com and other available public sources; and
- You should conduct an in-depth investigation of the Profiled Company and its securities from the above or any other credible available sources, especially because we only present positive information and limited specific information which is an insufficient basis to invest in any stock, yet alone a penny stock; accordingly, you should proceed with an investigation to determine, among other things, information pertaining to the issuer's financial condition, operations, business model, and risks involved in the issuer's business.
Section 17(b) of the Securities Act of 1933 requires that any person that uses the mails to publish, give publicity to, or circulate any publication or communication that describes a security in return for consideration received or to be received directly or indirectly from an issuer, underwriter, or dealer, must fully disclose the type of consideration (i.e. cash, free trading stock, restricted stock, stock options, stock warrants) and the specific amount of the consideration. In connection therewith, EMC has received the following compensation and/or has an agreement to receive in the future certain compensation, as described below. EMC has been Paid 250,000 restricted shares from Brainstorm
Emerging Markets Consulting, LLC – All rights reserved. Any duplication or copying of the foregoing text (in part or in full) or cutting and pasting the foregoing text that is then distributed to the public or through the facilities of interstate commerce constitutes a violation of the copyright laws, making the user of our information subject to a lawsuit for damages, including but not limited to any money the user makes by using the contents of the foregoing text.
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