- The clinical-stage biotech Pluristem Therapeutics ( NASDAQ: PSTI ) said on Wednesday that its Phase 3 study for PLX-PAD cells as a treatment for muscle injury following hip fracture surgery, did not reach the primary endpoint.
- The double blind, placebo-controlled study was designed to assess the intramuscular administration of allogeneic PLX-PAD cells in 240 patients in the U.S., Europe and Israel.
- According to topline data at Day 26, the trial did not meet the primary endpoint of Short Physical Performance Battery (SPPB) test, which consists of a series of physical performance tests used to measure the lower extremity function and mobility in older people.
- However, Pluristem ( PSTI ) said that PLX-PAD was found to be “an effective accelerator of muscle strength and regeneration.”
- “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,” Chief Executive Yaky Yanay remarked.
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Pluristem says Phase 3 trial for muscle injury therapy did not meet key goal