BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for debilitating neurodegenerative diseases, today announced that the Israel Patent Office has granted an additional patent titled “Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors.” The allowed claims cover the method of manufacturing the cells, the cells generated according to the method of manufacturing, and the use of the cells for preparation of a therapy for treating a disease (including a neurodegenerative disease, a neurological and an immune disease).
“Our intellectual property estate for NurOwn® technology platform continues to grow substantially as evidenced by this new patent granted by the Israel Patent Office which is a welcome addition to our IP portfolio. This patent covers NurOwn (MSC-NTF cells) and its manufacturing process developed by Brainstorm’s scientists as well as the use of NurOwn for the treatment of neurodegenerative diseases, an acute unmet need” commented BrainStorm’s CEO Chaim Lebovits. “Having an Israel patented product and manufacturing process will increase our ability to treat patients in desperate need of options for these debilitating diseases in Israel. We expect that additional patents owned or licensed exclusively by BrainStorm will be awarded this year and in future years, thereby broadening the utility of NurOwn in global markets across the world.”
NurOwn® (autologous MSC-NTF) cells are an innovative cellular technology platform that targets disease pathways known to be important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated under patented and scalable manufacturing processes that induce the cells to secrete high levels of neurotrophic factors and immunomodulatory cytokines. Autologous MSC-NTF cells can effectively deliver these factors directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is actively enrolling a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS) (NCT03280056). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis (MS) and plans to start enrollment in early 2019 (NCT03799718).
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS, investigating repeat intrathecal administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm’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 https://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.