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Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) reports positive 12-month results from the Phase I clinical trial of its placental stem cell treatment for critical limb ischemia (blockage of the arteries in the limbs, which can lead to gangrene and amputation). The trial of the PLX-PAD cells has met all its safety and efficacy endpoints at all dosage levels.
The trial included 27 patients. The trial is being conducted under protocols approved by the US Food and Drug Administration (FDA) and Germany's Paul-Ehrlich-Institute (PEI). Pluristem scientific advisory board chairman Dr. Edwin Horwitz of Pediatrics at the Children's Hospital of Philadelphia will present the results today at the World Conference on Regenerative Medicine in Leipzig.
The trial found no malignancies, adverse events, or immunological reactions in the patients. The PLX-PAD cells also do not induce tumorigenesis (creation of a tumor).
Under FDA and European Medicines Agency (EMEA) protocols, the primary endpoint in pivotal clinical trials for critical limb ischemia treatments is the Amputation Free Survival rate. The PLX-PAD cells therapy failed in four of the 27 patients, giving a rate was 85.2% after 12 months for the PLX-PAD cells therapy, compared with historical control data of 66.8% for the same period.
Pluristem's share price rose 2.1% on Nasdaq yesterday to $2.48, giving a market cap of $106 million, and rose 8.7% by midday on the TASE today to NIS 9.72.
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