Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of two clinical sites in the U.S. Duke University Medical Center will also be screening patients for the trial. The initiation of this study follows the approval of the Company’s Investigational New Drug (IND) application to begin clinical trials with PLX-PAD by the U.S. Food & Drug Administration (FDA). The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 12 adults with the disease will be included in this dose escalating trial.
“Initiation of the clinical trial in the U.S. with our unmatched placenta-derived stem cell therapy product signifies another major milestone for Pluristem,” said Zami Aberman, chairman, president and CEO of Pluristem. “This significant development, together with the beginning of dosing in Europe in July of this year, demonstrates our commitment to advancing our product pipeline and our strong position in the stem cell space.”
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