Invest in a New Era of ALS Treatment with BrainStorm Cell Therapeutics and Pluri’s Groundbreaking Partnership
We’re thrilled to announce that BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) and Pluri Inc. (NASDAQ: PLUR) have joined forces in a partnership poised to make an impact in the fight against ALS (amyotrophic lateral sclerosis). With BrainStorm’s proven capabilities in developing cellular therapies for neurodegenerative diseases and Pluri’s advanced cell-manufacturing technologies, the companies have signed a Memorandum of Understanding (MOU) to manufacture NurOwn®, BrainStorm’s pioneering treatment for ALS, in their upcoming Phase 3b clinical trial. This collaboration is not just a technical milestone; it’s a pivotal move that could drive both companies toward future commercial success and potentially make a meaningful impact on the lives of those affected by ALS.
Why This Partnership is a Game-Changer
This collaboration aims to meet growing demand for NurOwn® during clinical trials and to scale up production for potential commercial distribution upon approval. This marks a significant step forward for BrainStorm, which has been dedicated to ALS research and treatment development for years. By joining forces with Pluri, an industry leader known for its strict quality and regulatory standards, BrainStorm is positioned to accelerate progress on its ALS treatment and open the door for other commercial manufacturing options in the future.
Under the terms of the MOU, Pluri will provide manufacturing capacity for NurOwn® at its GMP-compliant facilities in Israel, ensuring that BrainStorm’s clinical trials have a consistent, high-quality supply of the treatment. This enables BrainStorm to advance toward completing its Phase 3b trial and positions them for a Biologics License Application (BLA) submission—a crucial step in potentially bringing NurOwn® to market for ALS patients.
“Pluri has become a recognized leader in GMP-compliant clinical manufacturing, known for their exceptional quality standards and regulatory compliance,” says Haro Hartounian, Ph.D., Chief Operating Officer at BrainStorm. “Having Pluri’s clinical manufacturing facility near BrainStorm’s R&D teams will foster a highly productive collaboration that will help us drive forward the development of NurOwn®.”
A Closer Look at the Phase 3b Trial
The upcoming Phase 3b trial for NurOwn® is designed to enroll approximately 200 participants with ALS. The trial will include two parts:
- Part A: Participants will receive three doses of NurOwn® or a placebo over 24 weeks, after which the primary efficacy will be evaluated by comparing ALS Functional Rating Scale-Revised (ALSFRS-R) scores for NurOwn® versus placebo.
- Part B: An open-label period in which all patients, regardless of group, will receive three doses of NurOwn® over an additional 24-week period.
Successful completion of Part A will not only provide vital efficacy data but could also fast-track the regulatory process for BrainStorm, potentially allowing them to submit a BLA and accelerate the path to market for this promising therapy.
What This Means for Investors
The ALS treatment market is projected to grow significantly as demand rises for new therapies that offer hope to patients. With this partnership, both companies are strategically aligned to capitalize on this opportunity while contributing to the advancement of innovative healthcare solutions. Pluri’s proprietary 3D cell-expansion technology and robust clinical-grade manufacturing infrastructure mean that BrainStorm can scale up to meet the needs of clinical trials and potential commercial distribution.
For investors, BrainStorm’s Phase 3b trial and Pluri’s involvement represent a promising alignment of expertise and capability. A successful trial could not only expedite NurOwn®’s journey to regulatory approval but also drive value for investors who are positioned to support an emerging leader in cell-based therapies for neurodegenerative diseases. Furthermore, the alliance signals a step toward future scalability in other markets where cell-based therapeutics are needed, such as treatments for multiple sclerosis and other neurodegenerative conditions.
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The Future of Cell Therapy
Beyond ALS, BrainStorm and Pluri’s collaboration underscores the broader potential of cell therapies and advanced manufacturing technologies. Pluri’s advanced 3D cell expansion platform can produce massive quantities of therapeutic cells efficiently and with high quality, which is crucial for scaling to meet global needs in healthcare. This technology, combined with BrainStorm’s proprietary NurOwn® platform, could set new standards for quality and accessibility in cell-based treatments.
About Pluri Inc.
Pluri Inc. is a global leader in cell-based therapeutic solutions, with applications spanning medicine, climate change, food production, and more. Pluri’s technology enables the creation of high-quality cell-based products through a state-of-the-art 3D cell-expansion system that supports everything from clinical trials to commercial production. For more, follow Pluri on LinkedIn and X (formerly Twitter).
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) focuses on developing autologous stem cell therapies for neurodegenerative diseases. With its exclusive NurOwn® platform, BrainStorm seeks to transform the treatment landscape for conditions like ALS. The company’s pioneering work has earned it FDA Orphan Drug status and opened the door to innovative therapeutic approaches that may shape the future of ALS treatment.
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