BrainStorm and Pluri: A Strategic Partnership for NurOwn's Phase 3b Trial
Monday, Nov 11, 2024 6:09 am ET
1min read BrainStorm Cell Therapeutics and Pluri Inc. have entered into a strategic partnership to support the manufacturing of NurOwn for BrainStorm's planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This collaboration will not only fulfill essential supply requirements for the trial but also explore options for future commercial distribution, pending approval of NurOwn.
Pluri's expertise in GMP-compliant manufacturing of cell-based products will ensure high-quality production of NurOwn, aligning with BrainStorm's commitment to regulatory compliance. With Pluri's manufacturing facility located near BrainStorm's manufacturing and R&D teams in Israel, communication and collaboration will be enhanced, fostering a productive environment for NurOwn's development.
The Phase 3b trial is designed to enroll up to approximately 200 participants with ALS and will be conducted in two parts. In Part A, participants will receive 3 doses of NurOwn or placebo for 24 weeks, followed by an open-label period in which patients from both arms will receive 3 doses of NurOwn for another 24 weeks (Part B). The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 for NurOwn versus placebo. Successful completion of Part A will position BrainStorm to submit a Biologics License Application (BLA) for regulatory approval, potentially accelerating the path to market.
BrainStorm's long-term commitment to ALS is demonstrated in its preclinical research and series of clinical studies, all of which have been published in peer-reviewed journals. The NurOwn clinical program has generated valuable insights into the pathology of ALS, disease progression, and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including quantification of Floor Effect, evaluation of multiple pre-specified biomarkers, and analysis of genetic data.
Pluri, a global leader in the development and manufacturing of cell-based therapeutics, is pushing the boundaries of science and engineering to create cell-based products for commercial use. This collaboration with BrainStorm is a testament to Pluri's commitment to supporting innovative therapies for devastating diseases like ALS.
In conclusion, the strategic partnership between BrainStorm and Pluri is a significant step towards advancing the NurOwn Phase 3b trial and potentially bringing hope to patients and families impacted by ALS. By leveraging Pluri's manufacturing expertise and BrainStorm's commitment to ALS research, this collaboration positions both companies to make a meaningful impact on the treatment landscape for neurodegenerative diseases.
Pluri's expertise in GMP-compliant manufacturing of cell-based products will ensure high-quality production of NurOwn, aligning with BrainStorm's commitment to regulatory compliance. With Pluri's manufacturing facility located near BrainStorm's manufacturing and R&D teams in Israel, communication and collaboration will be enhanced, fostering a productive environment for NurOwn's development.
The Phase 3b trial is designed to enroll up to approximately 200 participants with ALS and will be conducted in two parts. In Part A, participants will receive 3 doses of NurOwn or placebo for 24 weeks, followed by an open-label period in which patients from both arms will receive 3 doses of NurOwn for another 24 weeks (Part B). The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 for NurOwn versus placebo. Successful completion of Part A will position BrainStorm to submit a Biologics License Application (BLA) for regulatory approval, potentially accelerating the path to market.
BrainStorm's long-term commitment to ALS is demonstrated in its preclinical research and series of clinical studies, all of which have been published in peer-reviewed journals. The NurOwn clinical program has generated valuable insights into the pathology of ALS, disease progression, and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including quantification of Floor Effect, evaluation of multiple pre-specified biomarkers, and analysis of genetic data.
Pluri, a global leader in the development and manufacturing of cell-based therapeutics, is pushing the boundaries of science and engineering to create cell-based products for commercial use. This collaboration with BrainStorm is a testament to Pluri's commitment to supporting innovative therapies for devastating diseases like ALS.
In conclusion, the strategic partnership between BrainStorm and Pluri is a significant step towards advancing the NurOwn Phase 3b trial and potentially bringing hope to patients and families impacted by ALS. By leveraging Pluri's manufacturing expertise and BrainStorm's commitment to ALS research, this collaboration positions both companies to make a meaningful impact on the treatment landscape for neurodegenerative diseases.
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