BrainStorm to Host Call Following President Trump's Citing of Company's ALS Treatment During "Right-to-Try" Bill Signing
Published: Jun 01, 2018
Conference call and live webcast on June 7th at 8:15am EDT
NEW YORK and PETACH TIKVAH, Israel, June 1, 2018 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that the company will host a "Right-to-Try" (RTT) discussion call on Thursday, June 7th at 8:15am EDT.
On May 30, 2018, President Trump signed "Right-to-Try" legislation, which will enable terminally ill patients expanded access to experimental therapies that do not yet have approval by the U.S. Food and Drug Administration (FDA). During the signing, President Trump highlighted the urgency and need for patients who don't meet inclusion criteria's to have access to investigational treatments when they have exhausted all treatment options. He cited the example of Matthew Bellina, an amyotrophic lateral sclerosis (ALS) patient who had been seeking access to BrainStorm's NurOwn® investigational therapy but did not qualify for clinical trials in the U.S. Mr. Bellina had plans to travel to Israel to pursue access to NurOwn® treatment. The President stated clearly that, with the passage of this bill, patients will be able to seek treatment in the U.S. without the burden of having to travel overseas. BrainStorm's president and CEO Chaim Lebovits was present during the bill signing at the White House to support and demonstrate commitment to the ALS community.
To view President Trump's speech on C-SPAN (referencing ALS treatment in Israel at timecode 19:35 through 20:35) refer to https://cs.pn/2skXaus.
"Since the signing of the 'Right-to-Try' bill, we have had numerous enquiries from patients, patient advocates and physicians who want to voice their opinions as we establish our RTT policy," stated Mr. Lebovits. "As part of our commitment to the community, we are happy to provide interested groups this opportunity to engage directly with us. We recognize the sense of urgency of ALS patients such as Matthew Bellina, and are evaluating ways to provide access to NurOwn® outside of our Phase 3 trial. At the same time, we remain fully focused on completing our Phase 3 trial of NurOwn® as rapidly as possible."
Members of BrainStorm's senior management team, including Chaim Lebovits, president and CEO and Ralph Kern, M.D., MHSc, CMO and COO, will host a conference call and webcast for the ALS community and interested participants on Thursday, June 7 at 8:15am Eastern Time.
Conference Call Thursday, June 7th @ 8:15am Eastern Time ---------------------------------------- From the US: 800-263-0877 Outside the US: 646-828-8143 Israel: 1809 212 883 Conference ID: 9225858 Webcast: https://goo.gl/h9pMGE Replays, Available through June 21: From the US: 844-512-2921 Outside the US: 412-317-6671 Replay PIN: 9225858
NurOwn utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn.
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 70 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.
Chief Business Officer
BrainStorm Cell Therapeutics Inc.
LifeSci Advisors LLC
Matt Middleman, M.D.
LifeSci Public Relations, LLC
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SOURCE BrainStorm Cell Therapeutics Inc.