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Monday, December 14, 2020 9:01:59 AM
Dec. 14, 2020 8:46 AM ETBrainstorm Cell Therapeutics Inc. (BCLI)By: Mamta Mayani, SA News Editor
BrainStorm Cell Therapeutics (NASDAQ:BCLI) has initiated a NurOwn (MSC-NTF cells) Expanded Access Program (EAP) for patients with amyotrophic lateral sclerosis (ALS) who completed the Company's recently concluded Phase 3 trial.
The protocol for the EAP was developed in partnership with the FDA to provide access to NurOwn for Phase 3 clinical trial participants who meet specific eligibility criteria.
Initially, patients less severely affected by ALS will be the first to receive treatment.
The six clinical centers of excellence participating in the Phase 3 NurOwn trial will each have the opportunity to treat ALS patients who completed the trial.
The Dana Farber Cancer Institute will initially manufacture the investigational therapy, assisted by BrainStorm personnel who will be on-site.
NurOwn cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders.
Recent BCLI News
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 09/17/2024 07:32:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 08:36:41 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/09/2024 04:15:04 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 08/28/2024 09:01:02 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/16/2024 11:00:19 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 12:01:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 11:15:21 AM
- Form PRER14A - Preliminary Proxy Soliciting materials • Edgar (US Regulatory) • 08/06/2024 08:59:18 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 08/05/2024 09:11:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 08:05:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/24/2024 08:05:18 PM
- BCLI Update - Progress Supports Our 10x Plus Value Range Potential • PR Newswire (Canada) • 07/24/2024 12:30:00 PM
- BCLI Update - Progress Supports Our 10x Plus Value Range Potential • PR Newswire (US) • 07/24/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/19/2024 08:05:57 PM
- Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation • PR Newswire (US) • 06/14/2024 04:01:00 PM
- Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation • PR Newswire (Canada) • 06/14/2024 04:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 10:05:20 AM
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