Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced top-line results from its Phase I/II clinical trial testing the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury.
The trial indicated PLX-PAD cells were safe and statistical significance was reached for the primary efficacy endpoint of the study, the change in maximal voluntary isometric contraction force of the gluteal muscle at six months after total hip replacement . Patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group. These results provide evidence that PLX cells may be efficacious in the treatment of orthopedic injuries including muscles and tendons.
The primary safety endpoint was clearly met, with no serious adverse events reported at either dose level. The study showed that PLX-PAD cells were safe and well tolerated.
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The primary efficacy endpoint of the study was the change in maximal voluntary isometric contraction force of the gluteal muscle at six months post-surgery.
An analysis of the macrostructure of the gluteal muscle using magnetic resonance imaging (MRI) indicated an increase in muscle volume in those patients treated with PLX-PAD cells versus the placebo group. This efficacy endpoint was demonstrated in both PLX-PAD treated patient groups, with the group receiving the 150 million cell dose displaying a statistically significant superiority over the placebo group.
The study’s Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery, Julius Wolff Institute Berlin, Charité – Universitaetsmedizin Berlin, Germany, commented, “I am very impressed with the magnitude of the efficacy results seen in this trial. PLX cells demonstrated safety and suggested that the increase in muscle volume could be a mechanism for the improvement of contraction force.”
Zami Aberman Chairman and CEO stated, “This was a very important study not only for Pluristem but for the cell therapy industry in general. The study confirms our pre-clinical findings that PLX-PAD cell therapy can be effective in treating muscle injury. Having a statistically significant result for our primary efficacy endpoint is very encouraging and consistent with our understanding of the mechanism of action associated with cell therapy. Based on these results, we intend to move forward with implementing our strategy towards using PLX cells in orthopedic indications and muscle trauma.”
