Israel's Pluristem Therapeutics ($PSTI) says the FDA has given the company a green light to push ahead on a mid-stage study of one of its stem cell therapies after the agency had finished its review of one patient's severe allergic reaction and tweaked the trial protocol.
In a statement the biotech said the FDA "had satisfactorily addressed all the clinical hold issues" involving the study and the work can now proceed. The study protocol has been "tightened" to modify recruitment requirements for the 150-patient study, though there's no word on exactly what that means, while investigators will add an oral anti-histamine and a safety follow-up period for 24 hours post study treatment.
Pluristem shares jumped about 9% on the news this morning.
The agency clamped the clinical hold on the study on June 4, after about half of the projected 150 patients had been enrolled. The study is testing whether the biotech's PLX-PAD cells can improve walking distance for patients with intermittent claudication, occasional bouts of muscle pain in the leg brought on by inadequate blood flow. The company has an off-the-shelf stem cell product that it believes can be used for a variety of ailments.
Pluristem was roasted in the media last fall after the company enjoyed a big run-up of its stock price on its claim to have saved a girl's life with its experimental stem cell therapy. Top executives cashed in, but when the girl died a few months later, the company stayed mum--until a Bloomberg reporter tracked down the story.
"Pluristem applauds the FDA's vigor to resolve this clinical hold as quickly as possible," Pluristem CEO Zami Aberman said. "We look forward to resuming this important study that addresses the growing, costly and potential serious indication of intermittent claudication."
- here's the press release