Drug Development

Brainstorm’s rally fizzles after investors turn sour on questionable ALS data

Brainstorm Cell Therapeutics worked hard Monday morning to make the case that a small Phase II study of its lead stem cell therapy for amyotrophic lateral sclerosis (ALS) provided plenty of reasons for optimism about Phase III. But after taking a second look at the data, a short-lived pop in the company’s share price turned into a sharp decline by mid-morning.

The Israeli biotech $BCLI cut itself considerable slack in the study, setting a p value of <0.1 for statistical significance. They also set up a subset analysis to examine the effect on patients, “excluding slowly progressing patients who are less likely to have a detectable benefit from NurOwn.” And they added a survey of physicians to support their contention that even a modest change in the slope of decline for patients would be “clinically meaningful.”

The stem cell treatment also failed to demonstrate statistical significance on key secondary efficacy measures regarding disease progression. That’s the disheartening point that investors eventually focused on, as Brainstorm’s 18% spike quickly turned into a 13% decline.

Adam Feuerstein at TheStreet got a chance to look at the data under embargo, and noted that the biotech needs to raise more cash for the Phase III.

Stem cell therapies have had a hard time in general and ALS drugs have experienced a hard time in particular. Brainstorm would appear to be worse off after today, though, rather than better.

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