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|BrainStorm Expands Manufacturing of NurOwn® for Phase 2 Progressive MS Trial|
MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.
“We are excited to rapidly advance our investigational stem cell therapy for progressive MS patients and sincerely thank the Connell and O'Reilly Families Cell Manipulation Core Team for allocating resources and dedicated manufacturing space to allow us to initiate our Phase 2 progressive MS study in early 2019,” said
BrainStorm expanded the existing manufacturing contract with the Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) at Dana-Farber Cancer Institute (Dana-Farber), to also produce NurOwn® for the new Phase 2 progressive MS trial in addition to supporting ongoing production for the Phase 3 pivotal ALS trial.
The CMCF Team at Dana-Farber is collaborating with clinical researchers in advancing novel cell-based therapies in trials for cancer and other diseases (like ALS and progressive MS) to evaluate the potential of adoptive cell therapy (for investigational cell product candidates like CAR-T cells and NurOwn®).
“Cellular therapies represent an exciting new therapeutic modality that can potentially benefit patients who do not have other effective treatment options. We are very glad to support BrainStorm’s plan to evaluate the potential role of NurOwn® in the treatment of other debilitating neurologic diseases such as progressive Multiple Sclerosis,” said
NurOwn® (MSC-NTF) cells represent 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. Autologous MSC-NTF cells can 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. BrainStorm is currently conducting a pivotal Phase 3 clinical trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS).
About BrainStorm Cell Therapeutics Inc.