BrainStorm Announces Publication of New Preclinical Data Supporting Proposed NurOwn® Mechanism in ALS, Progressive MS and Alzheimer's Disease
NEW YORK, Aug. 19, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the publication of a manuscript titled, "Effects of MSC-NTF cells on T and B regulatory cell function in ALS" in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
NurOwn® (MSC-NTF cells) are autologous, mesenchymal stem cells induced by a culture-based approach to secrete significant higher levels of neurotrophic factors while retaining their intrinsic immunomodulatory activity. Brainstorm has demonstrated that a single administration of NurOwn increased circulating T regulatory cells in a phase 2a open label study and reduced cerebrospinal fluid (CSF) inflammatory biomarkers in a phase 2 randomized clinical study. To explore the link between these important biomarker observations, Brainstorm conducted a series of preclinical experiments in order to evaluate the potential of NurOwn to induce T and B regulatory cells and IL-10 secretion and confirm their immunomodulatory effects. Decreased T and B regulatory function appears to impact disease progression in ALS and other neuroinflammatory diseases. T and B cell secreted IL-10 may enhance microglia and cytokine networks and have shown therapeutic potential in ALS and neuroinflammatory preclinical models.
In the preclinical experiments, a significant (p<0.0001) decrease of interferon-g secretion by peripheral blood mononuclear cells (PBMC) in the presence of NurOwn® was demonstrated. When co-cultured with PBMC, NurOwn® induced CD4+CD25+FoxP3+ T regulatory cells (p < 0.001). When cocultured with B cells, NurOwn induced CD24hiCD38hi B regulatory cells, and increased IL-10 secretion (p < 0.001).
"These preclinical observations extend the understanding of immunomodulatory effects of NurOwn on CSF inflammatory biomarkers demonstrated in the US phase 2 randomized clinical trial by providing specific mechanisms by which NurOwn may exert its beneficial effects on these important cytokine pathways," said Ralph Kern MD MHSc, President and Chief Medical Officer of Brainstorm.
Chaim Lebovits, Brainstorm Chief Executive Officer added, "We continue to expand our scientific knowledge of NurOwn's mechanism of action through preclinical and clinical research. Our goal is to efficiently bring practical solutions to patients in need, through innovative science, completion of the phase 3 ALS clinical trial and advancement of clinical programs in progressive MS and Alzheimer's disease."
About BrainStorm Cell Therapeutics Inc.
(NCT03280056); this trial is investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.
For more information, visit the company's website at www.brainstorm-cell.com.
View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-publication-of-new-preclinical-data-supporting-proposed-nurown-mechanism-in-als-progressive-ms-and-alzheimers-disease-301114814.html
SOURCE BrainStorm Cell Therapeutics Inc.
Company Codes: Berlin:GHDN, NASDAQ-SMALL:BCLI, Frankfurt:GHDN, Munich:GHDN, Stuttgart:GHDN