Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (“Pluristem” or the “Company”), a leading biotechnology company, today announced topline results from its multinational double-blind, placebo-controlled phase III study. The Company designed the study to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture. The study enrolled 240 patients in the United States, Europe, and Israel.

PLX-PAD was demonstrated to be an effective accelerator of muscle strength and regeneration. A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52 for patients treated with PLX-PAD (n=120), in the injured leg (p=0.047, p=0.0022) and uninjured leg (p=0.073, p=0.0046) compared to placebo (n=120). This new data confirms the results demonstrated in Pluristem’s phase I/II study.
The study did not meet the primary endpoint, which 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.1

PLX-PAD was well tolerated and demonstrated a significant increase in HAS:

In the injured leg:
- Patients treated with PLX-PAD cells showed an increase of 3.2kg from reference (week 6) to week 26 compared to 1.3kg in the placebo group, a 2kg difference (p=0.047).
- Patients treated with PLX-PAD cells showed an increase of 5.01kg from reference (week 6) to week 52 compared to 0.86kg in the placebo group, a 4kg difference (p=0.0022).
In the uninjured leg:
- Patients treated with PLX-PAD cells showed an increase of 2.3kg from reference (week 6) to week 26 compared to 0.51kg in the placebo group, a 1.8kg difference (p=0.073).
- Patients treated with PLX-PAD cells showed an increase of 3.3kg from reference (week 6) to week 52 compared to a decrease of 0.7kg in the placebo group, a 4kg difference, (p=0.0046).
When comparing the absolute HAS between study groups (treated versus placebo) at week 52, patients treated with PLX-PAD showed a 2.6kg higher score than placebo treated patients in the injured leg (p=0.0511). A similar benefit was seen in the uninjured leg, with a 2.2kg difference (p=0.113).

The increase in HAS was further supported by a positive trend in a 6-minute walk test at week 52, showing an increase in walking distance:

PLX-PAD treated patients (N=36) were able to walk 296 meters versus only 266 meters in placebo treated patients (N=45). The 6-minute walk test evaluates the global and integrated responses of all the systems involved in walking (pulmonary, cardiovascular, systemic and peripheral circulation, musculoskeletal function, neuromuscular units, and muscle metabolism), and is an acceptable functional endpoint.

Pluristem Reports Topline Results From Its Phase III Study Of Muscle Regeneration Following Hip Fracture Surgery