U.S. FDA Clears Pluristem’s Phase III Study in Treatment of Muscle Injury Following Hip Fracture Surgery

Pluristem Therapeutics (Nasdaq:PSTI) a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has cleared Pluristem’s Investigational Drug Application (IND) for a Phase III study of its PLX-PAD cell therapy in the treatment of muscle injury following surgical repair (arthroplasty) of the hip joint due to fracture.

As quoted in the press release:

Pluristem is in discussions with several EU countries to approve this study in Europe as well and expects to begin patient enrollment in both regions during 2018. Non-dilutive funding totaling $8.7 million (7.4 million Euro) has been granted to this study from Horizon 2020, the European Union’s largest research and innovation program.

The Phase III study follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when using PLX-PAD cells in total hip arthroplasty patients. The study demonstrated a 300% change in muscle volume (p=0.004) and a 500% (p=0.0067) change in muscle force at 6 months post-surgery, compared to the control group.

The Phase III, multinational, randomized, double-blind, placebo-controlled study will assess the efficacy and safety of intramuscular (IM) administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, as compared to placebo treatment. Through clinical sites in the U.S. and Europe, 240 patients will be randomized on a 1:1 allocation to be dosed with 150 million PLX-PAD cells or placebo on the day of surgery. The primary endpoint is the change in the short physical performance battery (SPPB) score at week 26 after treatment.

Click here to read the full press release.