One of the patients enrolled in a mid-stage study for an experimental stem cell therapy from Pluristem Therapeutics suffered a severe allergic reaction, sending him to the hospital and prompting FDA officials to clamp a clinical hold on the study.
The patient was released a day after the incident, but FDA officials want to suspend the IND 15038 trial to determine if the 74 people recruited for the study face a safety threat. The biotech is developing "off-the-shelf" cell therapies for a range of conditions, including peripheral artery disease. Pluristem's shares ($PSTI) plunged 17% on the news.
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. Now it has a new public relations disaster to deal with.
"Once we receive the letter, we will work closely with the FDA to address all issues raised. We are committed to our strategy that our competitive technology advantage be involved in clinical programs for multiple indications," says Zami Aberman, the CEO of the Israeli biotech.
Pluristem says that the FDA indicated it will send over a letter in the next 30 days outlining its questions about the program.
- here's the press release