BrainStorm Cell Therapeutics announced it has selected Worldwide Clinical Trials as its Clinical Research Organization (CRO) for its planned Phase 3 study of NurOwn in the treatment of amyotrophic lateral sclerosis (ALS). A study kick-off meeting is expected this month.
"Selecting a CRO is a critical step before initiating patient enrollment into our Phase 3 study of NurOwn in the treatment of ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We see Worldwide as the ideal partner for this important clinical trial - its deep expertise and capabilities in managing pivotal Phase 3 clinical trials in more than 60 countries, particularly in the fields of ALS and neurology, will be tremendous assets to us."
With support from Worldwide, BrainStorm will proceed with conducting a randomized, double-blind, placebo-controlled multi-dose Phase 3 trial that will be conducted at multiple sites.