FDA and the Paul Ehrlich Institute (Germany) Approve Pluristem's Regulatory Submissions in Support of a Phase I/II Clinical Trial Utilizing PLX-PAD for Peripheral Artery Disease
NEW YORK, May 06, 2008 (BUSINESS WIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that the Paul Ehrlich Institute (PEI) in Germany has approved the pre-clinical study synopsis to support a Phase I/II clinical trials in Germany and that the Center for Biologics Evaluation and Research (CBER), a division of the US Food and Drug Administration (FDA), has approved the synopsis to conduct a Phase I clinical trial in the US utilizing PLX-PAD for the treatment of limb ischemia associated with peripheral artery disease (PAD). The PEI is the German federal authority granting clinical trial approvals.
PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX(TM) technology
The regulatory and scientific package submitted to both authorities contains detailed information on the clinical indication, product properties, the Good Manufacturing Practices (GMP) manufacturing process for the production of PLX-PAD, and the clinical protocol synopsis for the planned Phase I/II clinical trial. The package also contains information on the safety and biodistribution study designs required to file an investigational new drug (IND) application.
Mr. Zami Aberman, Pluristem's President & CEO, stated: "I am proud that our team has accomplished this important milestone in achieving the FDA and PEI approval of our clinical route. We believe that this now paves the way to submit an IND using PLX-PAD for limb ischemia this summer and hopefully begin our Phase I/II clinical trials in 2008."
About Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with peripheral artery disease (PAD). The disease is characterized by narrowing and hardening of the arteries in the patient's limb(s) caused and/or aggravated by conditions such as diabetes, Buerger's Disease and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications, including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The current market for therapeutics and other interventions to treat limb ischemia is estimated to be approximately $1.2 billion.
About Pluristem
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental mesenchymal stromal cells (MSCs) are expanded in the Company's proprietary PluriX(TM) 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes the resultant PLX (PLacental eXpanded) cells are multi-potent and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and have immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company's products in development also include PLX-I, targeting the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; PLX-STROKE, targeting ischemic stroke victims; and PLX-MS, targeting Multiple Sclerosis.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
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