BrainStorm chooses Worldwide as CRO for Phase III ALS trial


US-based biotechnology company BrainStorm Cell Therapeutics has chosen Worldwide Clinical Trials as the clinical research organisation (CRO) for its upcoming Phase III clinical trial of NurOwn for treatment of patients with amyotrophic lateral sclerosis (ALS). 

Developed by professors at Tel Aviv University, NurOwn is a cell therapy platform designed to leverage mesenchymal stem cells (MSCs) for providing customised treatment of neurodegenerative diseases.

The NurOwn technology converts MSCs into biological factories that secrete different types of growth factors called neurotrophic factors (NTFs), which are specifically delivered at or close to the target site.

The randomised, double-blind, placebo-controlled multi-dose Phase III trial will evaluate NurOwn at several clinical centres in the country. 

"Selecting a CRO is a critical step before initiating patient enrolment into our Phase III study of NurOwn in the treatment of ALS."

BrainStorm Cell Therapeutics CEO Chaim Lebovits said: "Selecting a CRO is a critical step before initiating patient enrolment into our Phase III study of NurOwn in the treatment of ALS." 

With operations in North and South America, Eastern and Western Europe, Russia and Asia, Worldwide specialises in various therapeutic areas such as neuroscience, cardiovascular, immune-mediated inflammatory disorders (IMID) and rare diseases. 

Under an exclusive worldwide licensing agreement with the Tel Aviv University’s technology transfer firm Ramot, BrainStorm holds the rights to develop and commercialise NurOwn. 

To date, around 75 ALS patients had been administered with NurOwn as part of the trials conducted in the US and Israel.


Image: MRI of amyotrophic lateral sclerosis. Photo: courtesy of Frank Gaillard.