Pluristem's Phase 3 Study Of PLX-PAD To Treat Muscle Injury Does Not Meet Primary Goal

(RTTNews) - Pluristem Therapeutics Inc. (PSTI) on Wednesday said the Phase 3 study evaluating PLX-PAD for the treatment of muscle injury following arthroplasty for hip fracture did not meet its primary goal.

The primary endpoint of the study, that enrolled enrolled 240 patients, was the Short Physical Performance Battery (SPPB) test at week 26. The SPPB is a series of physical performance tests used in older persons to assess lower extremity function and mobility.

However, a significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52 for patients treated with PLX-PAD, the company said.

"While we were disappointed that this significant benefit did not translate to an SPPB score improvement, Pluristem will seek further regulatory advice to find a way to bridge the gap between the clear impact on muscle strength and the functionality score," said Pluristem Chief Executive Officer and President, Yaky Yanay.