Healthcare Industry News: peripheral artery disease
News Release - September 23, 2009
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 DiseaseHAIFA, Israel, Sept. 23--(HSMN NewsFeed)--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.
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Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we say that injecting the first patient in the U.S. with PLX-PAD is a significant step towards finding a potential effective treatment for CLI, or that 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, or that we expect to complete the Phase I safety trials both in the U.S. and Europe within the next 12 months, or that our placenta-derived stem cell therapy is unmatched, we are using forward-looking statements. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
For more information visit our website at www.pluristem.com, the content of which is not part of this press release.
Source: Pluristem Therapeutics
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