- Pluristem Therapeutics Inc PSTI announced topline results from its Phase 3 study of intramuscular administration of allogeneic PLX-PAD cells for muscle injury following arthroplasty for hip fracture.
- The 240-subject study did not meet the primary endpoint, 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.
- PLX-PAD was demonstrated to be an effective accelerator of muscle strength and regeneration.
- Related: Pluristem’s PLX-R18 Shows Meaningful Advantage Over Other Treatments In Transplant Patients.
- A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52.
- In the injured leg, PLX-PAD cells showed an increase of 3.2kg from week 6 to week 26 compared to 1.3kg in the placebo group. At 52 weeks, the difference was 4kgs.
- In the uninjured leg, PLX-PAD cells showed an increase of 2.3kg vs. 0.51kg in the placebo group, a 1.8kg difference, with a 4kg difference at 52 weeks.
- A positive trend in a 6-minute walk test at week 52 was observed, showing an increase in walking distance.
- Price Action: PSTI shares are down 7.55% at $1.10 during the market session on the last check Wednesday.
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