Brainstorm Cell Therapeutics has announced that the Data and Safety Monitoring Board, an independent group of experts responsible for assessing safety of ongoing clinical trials, has given the green light for the company to continue its phase II clinical trial of NurOwn for ALS. The safety review was based on data from 47 of the 48 patients enrolled in the U.S.-based randomized, double-blind, placebo-controlled phase II clinical trial (see Apr 2014 news). Both the intrathecal and intramuscular injections of the autologous, neurotrophic factor-secreting mesenchymal stem cells were deemed safe and well-tolerated. This milestone is one of several recent advances for the company: it has also recently been awarded a major grant from Israel’s Office of the Chief Scientist to advance the NurOwn program, and has secured a partnership to improve and scale up manufacturing of NurOwn.
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