FDA lifts hold on Pluristem's PLX-PAD Phase II trial

Pluristem Therapeutics Inc. (NASDAQ:PSTI; Tel Aviv:PSTI) said FDA lifted a clinical hold on a U.S. Phase II trial of PLX-PAD -- allogeneic, placental-derived expanded (PLX) cells -- to treat intermittent claudication. The agency placed the hold on the trial in early June after a severe allergic reaction in a patient "with multiple diseases" that required hospitalization. The company said the patient was discharged the next day after symptoms resolved (see BioCentury Extra, June 4).

Pluristem said it will modify the trial design by tightening patient eligibility criteria, adding oral anti-histamines to the dosing regimen and including a safety follow-up period of 24 hours post-treatment. The company could not be reached for details. ...