Pluristem Therapeutics Doses First Patient in U.S. With Placenta-Derived Stem Cell Product PLX-PAD in a Phase I Clinical Trial for Treatment of Peripheral Artery Disease
- Category: DNA RNA and Cells
- Published on Wednesday, 23 September 2009 03:00
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Pluristem Therapeutics 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)
HAIFA, Israel | September 23, 2009 | 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.
Pluristem Therapeutics Inc. is a clinical development bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), a “First-In-Human” placental-derived mesenchymal-like stromal cell product, has received both the FDA and Paul Erlich Institute (PEI) clearance and is being investigated in Phase I clinical trials. The Company is developing a pipeline of products derived from human placenta, a non-controversial, non-embryonic, adult stem cell source. The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use, and require no histocompatibility matching.
The company's additional product candidates include PLX-IBD, targeting Inflammatory Bowel Disease, which includes Crohn’s disease and Ulcerative Colitis; PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
SOURCE: Pluristem Therapeutics Inc.