Webcast and Conference Call at 8:30am Eastern Time Today
NEW YORK and PETACH TIKVA, Israel, June 26, 2018 /CNW/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that after careful evaluation of the newly enacted "Right to Try" (RTT) Act, it will not make NurOwn® available under this legislation at this time. The company will continue to focus efforts on completing the ongoing NurOwn® Phase 3 study as quickly as possible with the goal of bringing a meaningful treatment option to amyotrophic lateral sclerosis (ALS) patients.
Brainstorm has carefully evaluated the ethical, legal and practical aspects of the newly enacted RTT legislation in detail, and has received detailed feedback from patients, clinicians, regulatory and legal experts. The company has established an ethical and practical framework with four key elements that must be satisfied in order to be able to provide NurOwn® to ALS patients under the RTT pathway. The four elements are: providing the treatment to a limited number of patients at clinical trial-experienced sites to ensure the necessary expertise and systems of care are in place to safely and effectively deliver the therapy; ensuring that patients are fully educated on the benefits and risks of the investigational therapy; limiting the inclusion to patients who do not meet the Phase 3 clinical trial inclusion criteria to ensure that the RTT pathway does not adversely impact the clinical trial; and lastly, finding alternative funding solutions for patients who are unable to afford the high cost of regenerative medicine cell therapies. The company has found practical solutions for all except the funding issue and, as a consequence, is unable to initiate the provision of NurOwn® under the RTT pathway until all elements are fully satisfied.
"We feel a tremendous sense of urgency and responsibility to provide an ethical, compassionate, and well-reasoned practical response to the demand for NurOwn® and have worked tirelessly with patients and other stakeholders to find a solution," said Chaim Lebovits, president and CEO of BrainStorm, "As we were unable to identify a practical funding solution, we unfortunately are not in a position to initiate access to NurOwn® under RTT at this time."
Webcast and Conference Call, Tuesday, June 26, 2018 @ 8:30am Eastern Time
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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 approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.
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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