BrainStorm Cell Therapeutics has contracted with the Connell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute as a second U.S. manufacturing site to supply NurOwn for the company's ongoing randomized, double-blind, multi-dose Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS) as well as other potential indications.
"We are pleased to announce a second partnership with Dana-Farber for the manufacturing of NurOwn," said Chaim Lebovits, president and CEO of BrainStorm. "Dana Farber is a world-renowned institution with decades of experience in stem cell transplantation. Its strong capabilities in this area and proven track record in the manufacture of NurOwn in the phase 2 trial, make it an ideal partner as we advance our Phase 3 trial to completion."
"We are pleased to support this important clinical trial. ALS is a devastating disease with no effective therapies. Our participation will allow more rapid patient accrual and will lead to earlier completion of the study," said Jerome Ritz, MD, Executive Director of the Connell and O'Reilly Families Cell Manipulation Core Facility.
In partnering with Dana-Farber for the manufacturing of NurOwn, BrainStorm has secured an additional facility to enhance production for the ongoing pivotal Phase 3 clinical trial, and to support manufacturing capacity for additional clinical indications.
BrainStorm has also updated CMC activities at City of Hope and enrollment in all six U.S. clinical sites are proceeding well. The first meeting of the Phase 3 Data and Safety Monitoring Board (DSMB) is expected by the end of August 2018 and Brainstorm will provide an update thereafter.
The Phase 3 trial is designed to enroll 200 patients with ALS, and is being conducted at six leading ALS clinical sites in the U.S. The primary outcome measure is the ALSFR-S score responder analysis.