NEW YORK (AP) — Pluristem Therapeutics Inc. said Tuesday the Food and Drug Administration suspended a clinical trial of one of its stem cell therapies, sending the company's shares lower.
Pluristem said one patient in a mid-stage clinical trial suffered a severe allergic reaction to treatment and was hospitalized. The company said a total of 74 patients have been treated in its studies and this is the first serious allergic reaction. Pluristem said the patient had "multiple diseases" which may have made her allergic reaction worse. The patient was discharged from the hospital the next day, after all of her symptoms had cleared up.
The Israeli company said the FDA will send it a list of questions and requests for information within 30 days. Pluristem said it will work with the FDA to resolve those issues and restart the trial.
Shares of Pluristem lost 46 cents, or 13.8 percent, to $2.88 in midday trading. The shares have traded between $2.26 and $5 in the last year.
Pluristem is studying a placenta-based stem cell therapy called PLX as a treatment for conditions including peripheral artery disease, or the narrowing of large arteries that supply blood to the extremities. The suspended trial is intended to study the cells as a treatment for a symptom of peripheral artery disease called intermittent claudication, or pain in the calves following exercise.
Pluristem said about 15 percent of patients with the condition eventually develop critical limb ischemia, or blockages in the leg arteries.