NEW YORK and PETACH TIKVAH, Israel, Dec. 22, 2014 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, will release the final results from its phase 2a clinical trial of NurOwn in amytrophic lateral sclerosis (ALS) and hold a conference call and webcast to discuss the data on Monday, January 5, 2015. The 8:30 AM EST conference call and webcast presentation will be hosted by BrainStorm management, Professor Dimitrios Karussis, the principal investigator of this study, and Dr. Moshe Neuman of Bio-Medical Research Design, the CRO for the study.
BrainStorm’s CEO, Tony Fiorino, MD, PhD, stated, “We are very excited to share the final results of this study. Professor Karussis presented a very positive and well-received interim analysis of this study at the Joint Congress of European Neurology in June 2014, and the final results include data from several additional subjects and analyses conducted by our independent statisticians. The interim analysis of this study, and results of our prior phase 1/2 study, have shown that a single dose of NurOwn is safe and can provide clinically meaningful benefits to ALS patients, such as a reduction in the rate of progression, and in some patients, actual improvements in function. The final results will extend these findings and allow us to move forward with a presentation and publication strategy so that we may share these important data with our medical and scientific colleagues.”
Conference call and webcast details are below.
Monday, January 5, 2015 at 8:30 AM Eastern Standard Time | |
US Toll Free: | 888-401-4668 |
Israel Toll Free: | 180-924-5906 |
Conference ID: | 6267823 |
Webcast: | |
Please note that the slides will only be available via the webcast. | |
A replay will be available through January 19, 2015: | |
Toll Free: | 877-870-5176 |
International: | 858-384-5517 |
Replay PIN: | 6267823 |
About the Phase 2a Study
This single-arm dose-escalation trial, conducted at Hadassah Medical Center in Jerusalem, enrolled 14 ALS patients, all of whom received a single administration NurOwn via both intrathecal and intramuscular injection. The study assessed both the safety and the efficacy of three ascending doses of NurOwn. Subjects in this study underwent a three month run-in period to establish a baseline rate of disease progression, during which bone marrow-derived mesenchymal stem cells were isolated, expanded and differentiated using BrainStorm’s proprietary technology that induces expression of neurotrophic factors. After NurOwn administration, subjects were followed for another six months of safety and efficacy assessments. Further details may be found at https://clinicaltrials.gov/show/NCT01777646.
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. NurOwn has been administered to over 30 patients with ALS in clinical trials conducted in Israel, and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States. 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 at http://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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SOURCE BrainStorm Cell Therapeutics Inc.
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