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13 Nov 2024
Admin
News Article

BrainStorm Enters into Partnership with Pluri on Phase 3b Manufacturing for NurOwn® Trial

Overview

BrainStorm Cell Therapeutics has signed a Memorandum of Understanding (MOU) with Pluri to support its upcoming Phase 3b trial for NurOwn®, a treatment under investigation for amyotrophic lateral sclerosis (ALS).

NurOwn® Technology Platform

The NurOwn® technology platform uses autologous MSC-NTF cells, developed through a proprietary process to secrete neurotrophic factors targeting key pathways in neurodegenerative diseases.
The primary focus of this program is ALS, where cells are harvested from each patient and customised for treatment.

Impact of Collaboration

This agreement allows BrainStorm to transfer its manufacturing technology and prepare for production of NurOwn at Pluri’s facility, pending a binding agreement.

Location & Future Manufacturing

The collaboration, which will take place at Pluri’s GMP-compliant facility in Israel, aims to secure the necessary supply of NurOwn for BrainStorm’s Phase 3b trial.
In addition to meeting trial demands, both companies are evaluating options for future manufacturing to potentially support commercial distribution, should NurOwn gain regulatory approval.

Pluri’s production capability will also complement BrainStorm’s ongoing development and manufacturing efforts at The Center for Advanced Cellular Therapies (I-ACT) in Israel, enhancing proximity and cooperation with BrainStorm’s research and development teams.

The Trial

The Phase 3b trial, which will enrol approximately 200 participants with ALS, will be conducted in two stages.
In Part A, participants will receive either NurOwn or a placebo over a 24-week period.
Following this, Part B will involve an open-label phase where patients from both groups will receive NurOwn over another 24 weeks.
Primary aim:- The trial’s primary goal is to assess changes in ALSFRS-R scores from baseline to week 24 between the NurOwn and placebo groups, which, if successful, will support BrainStorm’s aim to file a Biologics License Application (BLA) for regulatory review.

The Commitment

BrainStorm’s commitment to ALS is reflected in extensive preclinical and clinical research, which has been published in peer-reviewed journals.
These studies have provided valuable insights into ALS pathology, progression, and potential treatment strategies, exploring the 'floor effect', biomarker assessments, and genetic data across a longitudinal trial period.

This pharmacogenomic approach could advance the future development of ALS treatments.

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