WCT selected to conduct Ph III NurOwn Trial in ALS

04-Jul-2017 - Last updated on 03-Nov-2017 at 20:55 GMT

Worldwide Clinical Trials is a contract research organization (CRO) with offices in North and South America, Eastern and Western Europe, Russia, and Asia. (Image: iStock/BernardaSv)

BrainStorm Cell Therapeutics has contracted Worldwide Clinical Trials (WCT) to conduct its planned Phase III study of NurOwn in the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases.

According to New Jersey-based company, a study kick-off meeting is expected later this month.

The company has an exclusive, worldwide licensing agreement with Ramon, Tel Aviv University’s technology transfer company, through which it holds the rights to develop and commercialize the NurOwn technology.

NurOwn previously demonstrated a clinically meaningful benefit of the technology in a randomized, double-blind, placebo-controlled clinical trial conducted in the US.

Subsequently, Brainstorm will conduct a randomized, double-blind, placebo-controlled multi-dose Phase III trial at multiple sites with support from WCT.

Chaim Lebovits, BrainStorm Cell Therapeutics CEO said selecting a contract research organization (CRO) is “a critical step before initiating patient enrollment” into the company’s Phase III study of NurOwn.