ENCALS Meeting, Edinburgh Scotland:
Presentation Details: ALS Phase 3 NurOwn Trial: Insight into the primary outcome through ENCALS modeled trajectories Presenter: Jonathan Katz MD, California Pacific Medical Center, San Francisco, CA USA Date/Time: Thurs June 2, 17.00-18.30 BST Conference Link: ENCALS
NurOwn's Phase 3 trial (BCT-002-US) included participants with advanced and rapidly declining ALS, making this trial subject to floor effects and reduced sensitivity of the clinical endpoint, the Revised ALS Functional Rating scale (ALSFRS-R). This presentation will summarize the clinical response on the primary endpoint this trial after applying two methods, ENCALS model and ALSFRS-R baseline value, to identify and minimize the impact of participant data most impacted by floor effects of the ALSFRS-R scale . Key findings:
In summary, the results confirm the importance of accounting for the floor effect in more advanced and rapidly declining ALS participants to potentially avoid misclassifying treatment responses.
CMSC 2022 Meeting, National Harbor MD, USA:
Presentation Details: NurOwn (MSC-NTF Cells) Phase 2 Clinical Trial in Progressive MS: Effects on Monocular and Binocular Low Contrast Letter Acuity (LCLA) Outcomes Presenter: Ralph Kern MD, MHSc, President and Chief Medical Officer, Brainstorm Cell Therapeutics. Date/Time: Thursday June 2, 2022, 17:00- 19:00 ET Conference Link: CMSC
This presentation evaluated the impact of NurOwn therapy on visual outcomes (monocular and binocular LCLA) in progressive MS study participants in an open-label Phase 2 clinical trial in progressive MS (NCT 03799718). The key findings were:
In summary, this Phase 2 study of NurOwn therapy in progressive MS demonstrated encouraging results in monocular and binocular LCLA that should be further evaluated in a placebo-controlled clinical trial. This poster was nominated for an award at the CMSC meeting.
Presentation Details: NurOwn (MSC-NTF) Phase 2 Clinical Trial in Progressive MS: Effects on CSF Inflammatory Biomarkers Presenter: Christopher Lock, MD PhD, Stanford School of Medicine. Date/Time: Thursday June 2, 2022, 17:00- 19:00 ET Conference Link: CMSC
In this scientific presentation, the effect of NurOwn treatment on CSF biomarkers in the Phase 2 clinical trial in progressive MS (NCT 03799718) is described. The key findings were:
In summary, these observations may guide future efforts to optimize this innovative autologous mesenchymal cellular therapy in progressive MS. This poster was nominated for an award at the CMSC meeting.
Presentation Details: NurOwn (MSC-NTF) Cells Maintain Neurotrophic and Immunomodulatory Effects with S1P Modulator Siponimod Presenter: Sidney Spector MD PhD, Senior Vice President, Medical Affairs and Global Strategy, Brainstorm cell Therapeutics Date/Time: Thursday June 2, 2022, 17:00- 19:00 ET Conference Link: CMSC
This presentation describes the results of an invitro preclinical experiment evaluating the interaction of the S1P modulator Siponimod with MSC-NTF cell-induced neurite outgrowth in a human neuroblastoma cell line, and on the immunomodulatory effect on human activated peripheral blood mononuclear cells (PBMC).
MSC-NTF cells were able to induce neurite extension and inhibit inflammatory cytokine secretion, a finding that was not modified by co-culture with Siponimod, an S1P modulator recently approved for the treatment of secondary progressive MS (SPMS).
In summary, this suggests that co-administration of Siponimod does not interfere with known measures of MSC-NTF cell neuroprotection and immunomodulation and may guide future efforts to optimize this innovative autologous mesenchymal cellular therapy in progressive MS.
CMSC abstracts are available on-line: abstracts
"We are very privileged to share scientific insights at these meetings with world experts in ALS and MS," said Ralph Kern MD MHSc, President and Chief Medical Officer at Brainstorm. "Importantly, these very insightful analyses help us identify where NurOwn may provide better benefits for ALS and MS patients. This work underscores our commitment to advancing our cellular therapy technology to address the unmet medical need in these two patient populations, while continuing to contribute to the scientific community."
Chaim Lebovits, CEO Brainstorm Cell Therapeutics commented, "Brainstorm is very proud of the continued efforts of our dedicated teams in advancing scientific understanding in ALS and progressive MS. We remain committed to addressing patient unmet needs and at the same time creating shareholder value".
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 used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).
Safe-Harbor Statement
Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, 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, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; 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.
Contacts
Investor Relations:
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LifeSci Advisors, LLC
Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com
Media:
Uri Yablonka
uri@brainstorm-cell.com