NEW YORK – BrainStorm Cell Therapeutics on Tuesday announced a strategic realignment plan, including layoffs, so that it can continue developing NurOwn (debamestrocel) in amyotrophic lateral sclerosis (ALS).
The New York-based biotech company last week said it had withdrawn its biologics license application for the stem cell therapy from US Food and Drug Administration review, though it plans to try for market authorization again after completing a Phase IIIb trial. The decision followed an FDA advisory committee meeting in which experts said the firm hadn't provided enough evidence of NurOwn's efficacy.
NurOwn comprises autologous multipotent stem cells derived from bone marrow, which are induced to secrete high levels of neurotrophic factors that support neuronal growth and survival.
BrainStorm on Tuesday said it planned to reduce resource consumption by 50 percent so that it can fund the planned double-blind, placebo-controlled Phase IIIb study with an open-label extension, in which it will evaluate biomarkers and NurOwn's impact on long-term safety and survival. As part of the strategic realignment plan, BrainStorm will also reduce its headcount by about 30 percent. Kirk Taylor, the company's executive VP and chief medical officer, who leads global medical affairs and launch activities, will also step down from his post.
BrainStorm is exploring ways of raising capital, including "non-dilutive grants and capitalizing on its exosome technology," the firm said. The company is also open to partnerships that could accelerate growth, according to BrainStorm President and CEO Chaim Lebovits.
"We remain steadfast in our goal to make NurOwn available to the ALS community as quickly as possible, and we believe that this strategic realignment offers our best chance for success," Lebovits said in a statement.