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Monday, December 27, 2021 10:53 AM | Kyle Depontes

Brainstorm Cell Therapeutics Inc. (BCLI)today announced plans for a dosing extension of NurOwn for Amyotrophic Lateral Sclerosis (ALS) participants who completed the Expanded Access Protocol (EAP).

Under the original EAP, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn.

Under the amended EAP, these eligible participants will receive up to 3 additional doses.

The company is also developing novel adult stem cell therapies for neurodegenerative disorders such as Progressive Multiple Sclerosis, and Parkinson's disease.

Shares of BCLI increased 1.19% to $3.76 as of Monday at 10:24am.

The expansion the Brainstorm's NurOwn trial will be an excellent opportunity for the company to test its technology through an expanded dosing program.

The NurOwn platform is a revolutionary technology that harnesses MSC-NTF cells, which are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) to deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to stabilize disease progression.

Robert Brown, Department of Neurology Chair at the University of Massachusetts and Principal Investigator, commented,"This dosing extension for the expanded access protocol is an appropriate next step following the new analysis and biomarkers results of the Phase 3 study."

"It is deeply appreciated by our ALS patients. Eligible patients now have the opportunity to receive as many as 9 doses of NurOwn in total, allowing additional data collection to better understand the potential benefits of longer-term treatment."

According to theFDA, EAPs, alternatively known as "compassionate use" programs, provide a pathway for appropriate patients to receive an investigational medicine for treatment of a serious disease outside of a clinical trial when no satisfactory alternative therapy options are available.

BCLI has a Fundamental Rank of 77. Find out what this means to you and get the rest of the rankings on BCLI!

Brainstorm Cell Therapeutics Inc is a biotechnology company. The company is developing novel adult stem cell therapies for debilitating neurodegenerative disorders such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Progressive Multiple Sclerosis (PMS), and Parkinson's disease (PD). Brainstorm's NurOwn, its proprietary process for the propagation of Mesenchymal Stem Cells (MSC) and differentiation into neurotrophic factor-(NTF) secreting cells (MSC-NTF), and their transplantation at, or near, the site of damage, offers the hope of more effectively treating neurodegenerative diseases.

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Brainstorm Cell Therapeutics (BCLI) Receives FDA Authorization for Expanded Dosing Program; Shares Higher - InvestorsObserver