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June 5, 2014
05:49 EDTPSTIPluristem CEO says muscle injury study suggests PLX-PAD effective treatment
Pluristem Therapeutics issued a Letter to Shareholders from its CEO, Zami Aberman. Aberman stated, "We have started 2014 with strong momentum on many fronts, including advancements in our clinical pipeline and regulatory approvals surrounding our cell therapy production methods and new manufacturing facility. The outstanding safety and efficacy results of our Phase I/II muscle injury study announced in January suggest that PLX-PAD cells may be effective in the treatment of muscle and tendon injuries. We analyzed the potential for a variety of orthopedic indications. Based on our findings and in keeping with our strategy, we have decided to move forward with at least two clinical indications, which will be announced in the next few weeks. Enrollment of the Phase II intermittent claudication, or IC, study is moving forward in the U.S., Germany and Israel and we expect to initiate enrollment in South Korea shortly."
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February 19, 2015
12:50 EDTPSTIPluristem says NIH study of PLX-R18 statistically significant
Pluristem Therapeutics announced the results of a recently completed trial conducted by the U.S. National Institutes of Health to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, the company said. It added, "The data also suggested that the treatment may potentially be able to shorten time to recovery."
February 18, 2015
09:10 EDTPSTIOn The Fly: Pre-market Movers
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05:17 EDTPSTIPluristem Therapeutics reports 'significant' findings in NIH trial of PLX-R18
Pluristem Therapeutics announced the positive results of a recently completed trial conducted by the U.S. National Institutes of Health, or NIH, to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation. The data also suggested that the treatment may potentially be able to shorten time to recovery. High levels of radiation can destroy the body's ability to produce these three blood lineages, and rapidly regaining that capacity is a key factor in surviving the hematologic component of acute radiation syndrome, or ARS, a condition caused by high-dose irradiation that can involve severe, sometimes lethal damage to the bone marrow as well as other physiologic systems and organs. The objective of this latest trial was to investigate the mechanism of action behind the significant improvement in survival in irradiated mice treated with PLX-R18 that was demonstrated in the NIH's first efficacy study. The results of the current study indicate that intramuscular administration exerts a systemic healing effect on bone marrow, lending further support to the concept that Pluristem's cells work systemically via secretion of therapeutic proteins, although the cells themselves remain in the muscle into which they were initially injected. While additional animal trials are needed prior to FDA approval of PLX-R18 for use in ARS, no human trials would be required because product development is conducted under the FDA's Animal Rule.

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