Pluristem Therapeutics Ltd. (Nasdaq:PSTI; FWB: PJTA; TASE: PSTI) has announced a new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA).
The company says that data showed that, six months after surgery, the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant. Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo.
Pluristem further announced positive twelve-month safety data from the trial.
These findings follow the January 21, 2014 announcement that the study had met its primary efficacy and safety endpoints.
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 impressed with the magnitude of the effect seen in the treated and contralateral legs. PLX cells demonstrated good safety and these newest findings suggest that intramuscular injection of PLX cells might potentially improve overall muscle functionality.”
Pluristem chairman and CEO Zami Aberman said, “It is very encouraging to have a large and statistically significant effect of PLX-PAD cells on our primary efficacy endpoint and also the unexpected finding of increased muscle strength in the non-operated leg. Although additional confirmatory studies are needed, these findings support our previous studies in which we showed that injection of PLX-PAD cells into muscle generates a systemic effect. The findings also open up new possibilities for the potential use of PLX-PAD cells. Based on these results, we intend to continue to develop PLX-PAD in orthopedic indications including sports injuries and muscle trauma, as well as muscle wasting and rehabilitation.”
Pluristem's share price rose strongly last week following a recommendation by Acceleron Equity Research. The share price fell back by about 10% on the Tel Aviv Stock exchange yesterday, but it is up 8.3% so far today.
Published by Globes [online], Israel business news - www.globes-online.com - on February 2, 2015
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