Pluristem Therapeutics Receives European Regulatory Approval For Placental-Derived Stem Cell Clinical Trial

Main Category: Stem Cell Research
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 17 Jun 2009 - 0:00 PDT

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Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has approved the Company's Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). In addition, Pluristem has already received approval from the Ethics Committee and, as previously announced, the US Food & Drug Administration (FDA) had cleared the Company's Investigational New Drug (IND) application to initiate a similar trial in the United States. Both approvals of the CTA and IND clear the way for the world's "first-in-man" clinical trial using PLX-PAD.

Pluristem's placental-derived stem cells are expanded using the company's proprietary 3D PluriX™ technology. PLX-PAD is an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients. In these phase I trials, to be conducted at multiple locations in the US and Germany, PLX-PAD will be administered to patients considered "late stage" that have not responded to traditional medical or surgical interventions.

Zami Aberman, Chairman, President and CEO of Pluristem stated: "Administering the first allogeneic stem cell product in Germany, Pluristem will be using PLX-PAD, our first product candidate in our cell therapy pipeline. Additionally, should the clinical trials in the US and Europe prove successful, it will have been the first time adult stem cells, derived from placenta and grown using our proprietary technology, have been administered to humans safely. Because our PLX cells are an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients, we believe this unique approach can provide patients with an affordable, immediate source of cell therapy. We believe all this positions Pluristem as a leader in the cell therapy field."

Professor Doctor Hans-Dieter Volk, Chairman of Charité-Universitaetsmedizin Berlin, Institute of Medical Immunology, and Chairman of the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) stated: "Pluristem's unique approach of implementing the placenta as the source for cell therapy can potentially be the key to future treatments that may help millions of patients. We at the BCRT believe that regenerative therapy using placental-derived cells has the potential to become the superior source for allogeneic cellular therapy."

About Critical Limb Ischemia

In the US alone, it is estimated that 8-12 million people suffer from critical limb ischemia associated with PAD. The disease is characterized by narrowing and hardening of the arteries in the patient's limb(s) caused and/or aggravated by diabetes, Buerger's Disease, other diseases 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, critical limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications.

Source
Pluristem Therapeutics Inc.

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