Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT) today announced the dosing of the first patient in the U.S. with its placenta-derived stem cell product, PLX-PAD, the Company’s leading candidate, in a Phase I clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
The patient was dosed at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of the clinical sites participating in this trial. Duke University Medical Center in Durham, North Carolina, is also screening patients for the trial.
“Injecting the first patient in the U.S. with PLX-PAD, Pluristem’s allogeneic placenta-derived stem cell product, is a significant step towards finding an effective treatment for CLI,” said Farrell O. Mendelsohn, M.D., the principal investigator and director at the Center for Therapeutic Angiogenesis in Birmingham, Ala. “Today marks the beginning of a new era in cardiovascular therapy as we used tissue that would have otherwise been discarded to potentially save a life.”
Zami Aberman, chairman, president and CEO of Pluristem added: “Treating the first patient in the U.S. with our unmatched placenta-derived stem cell therapy product signifies another major milestone for Pluristem, following the dosing of the first patient in Europe in July. We expect to complete the Phase I safety trials both in the U.S. and Europe within the next 12 months.”
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 in the U.S.
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