FDA Lifts Hold on Study of Muscle Pain Drug
Placental cells target claudication (September 16)
The FDA has lifted the clinical hold that it previously placed on the phase II Intermittent Claudication (IC) study on June 4, 2013.
In its letter to the drug’s developer (Pluristem Therapeutics), the FDA indicated that the company had satisfactorily addressed all of the clinical hold issues and may proceed with the study.
The IC trial will use PLX (PLacental eXpanded) cells, which release therapeutic proteins in response to local and systemic inflammatory and ischemic diseases. The cells require no tissue matching prior to administration.
PLX cells are designed to treat intermittent claudication, or pain caused by reduced blood flow to the muscles of the leg during exercise.
Up to 150 patients will be enrolled in the dose-escalation, randomized, double-blind, placebo-controlled IC trial, in which the primary endpoints at 12 months will be safety and maximal walking distance compared with baseline. The study protocol will be modified by tightening the patients’ eligibility criteria and by adding oral antihistamines and a safety follow-up period for 24 hours after study treatment.
Source: Pluristem Therapeutics; September 16, 2013.