{"id":517889,"date":"2021-07-27T06:03:29","date_gmt":"2021-07-27T10:03:29","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel\/"},"modified":"2021-07-27T06:03:29","modified_gmt":"2021-07-27T10:03:29","slug":"brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel\/","title":{"rendered":"BrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel"},"content":{"rendered":"
\n

GMP certification of three state-of-the-art cleanrooms more than doubles the Company’s manufacturing capacity for NurOwn\u00ae in Israel<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n NEW YORK<\/span>, July 27, 2021<\/span> \/PRNewswire\/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center<\/a>\u00a0(“Sourasky Hospital”)\u00a0in Tel Aviv, Israel<\/span>. The GMP approval confirms that these cleanrooms are compliant with Israeli GMPs, which are aligned with European Union (EU) GMPs, and more than doubles the Company’s capacity to manufacture and ship NurOwn\u00ae into the EU and local Israeli markets. <\/p>\n

\n \"BrainStorm\n <\/div>\n

“We are proud to be the first company to have been granted GMP<\/span> certificate at the Sourasky Hospital’s Institute for Advanced Cellular Therapies, that hosts a newly built state-of-the-art<\/span>cleanroom<\/span> suites to advance our proprietary cellular technology platform in ALS and other neurodegenerative diseases,” said Chaim Lebovits<\/span>, Chief Executive Officer of BrainStorm. “The GMP certification of these additional cleanrooms means that we now have more than doubled the capacity to supply NurOwn to ALS patients across Israel<\/span> and Europe<\/span>. This is critical, as ALS is a truly debilitating disease and patients are in urgent need of new therapies. We remain committed to addressing this unmet need and continue to discuss our clinical data with leading experts as we assess potentially regulatory pathways for NurOwn in various jurisdictions.”<\/p>\n

\n About NurOwn\u00ae\u00a0 <\/b>\n <\/p>\n

The NurOwn\u00ae technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.<\/p>\n

\n About BrainStorm Cell Therapeutics Inc.<\/b>\n <\/p>\n

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\u00ae 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).<\/p>\n

For more information, visit the company’s website at\u00a0www.brainstorm-cell.com<\/a>.<\/p>\n

\n Safe-Harbor Statement<\/b>\n <\/p>\n

Statements in this announcement other than historical data and information, including statements regarding future NurOwn\u00ae manufacturing and clinical development plans, 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, the prospects for regulatory approval of BrainStorm’s NurOwn\u00ae treatment candidate, the initiation, completion, and success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our 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\u00ae treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn\u00ae 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; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at\u00a0http:\/\/www.sec.gov<\/a>. 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.<\/p>\n

\n Contacts
<\/b>Investor Relations:
Eric Goldstein<\/span>
LifeSci Advisors, LLC
Phone: +1.516.521.2470
egoldstein@lifesciadvisors.com<\/a><\/p>\n

\n Media:
<\/b>
\n Paul Tyahla<\/span>
\n
SmithSolve
Phone: + 1.973.713.3768
Paul.tyahla@smithsolve.com<\/a><\/p>\n

\n \"Cision\" View original content:https:\/\/www.prnewswire.com\/news-releases\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel-301341805.html<\/a><\/p>\n

SOURCE Brainstorm Cell Therapeutics Inc<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

GMP certification of three state-of-the-art cleanrooms more than doubles the Company’s manufacturing capacity for NurOwn\u00ae in Israel PR Newswire NEW YORK, July 27, 2021 \/PRNewswire\/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center\u00a0(“Sourasky Hospital”)\u00a0in Tel Aviv, Israel. The GMP approval confirms that these cleanrooms are compliant with Israeli GMPs, which are aligned with European Union (EU) GMPs, and more than doubles the Company’s capacity to manufacture and ship NurOwn\u00ae into the EU and local Israeli markets. “We are proud to … <\/p>\n

Continue reading “BrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-517889","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nBrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"GMP certification of three state-of-the-art cleanrooms more than doubles the Company’s manufacturing capacity for NurOwn\u00ae in Israel PR Newswire NEW YORK, July 27, 2021 \/PRNewswire\/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center\u00a0(“Sourasky Hospital”)\u00a0in Tel Aviv, Israel. The GMP approval confirms that these cleanrooms are compliant with Israeli GMPs, which are aligned with European Union (EU) GMPs, and more than doubles the Company’s capacity to manufacture and ship NurOwn\u00ae into the EU and local Israeli markets. “We are proud to … Continue reading "BrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-27T10:03:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/1166536\/BrainStorm_Logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/brainstorm-increases-commercial-manufacturing-capacity-granted-gmp-certification-for-a-second-production-site-in-israel\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"BrainStorm Increases Commercial Manufacturing Capacity; 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