Pluristem Therapeutics Collaborates with the Charité - Universitätsmedizin Berlin and Franziskus-Krankenhaus Hospital for Its Clinical Trials in Germany
Business Wire
Posted: 2009-01-27 04:30:00
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 Company signed an agreement with Charité – Universitätsmedizin Berlin and Franziskus-Krankenhaus Hospital for the upcoming Critical Limb Ischemia (CLI) clinical trials in Germany utilizing Pluristem’s placental-derived adherent stromal cell product, PLX-PAD.
Pluristem plans to initiate its dose ranging clinical trials at the Charité and the Franziskus-Krankenhaus hospitals by administering PLX-PAD to patients afflicted with critical limb ischemia who have not responded to traditional medical or surgical interventions and are facing amputation.
“Signing an agreement with the Charite, a well respected European institution, was accomplished following the successful collection of double blinded preclinical efficacy and safety data, so the translation to the human clinical trial looks very promising,” stated Zami Aberman, Chairman, President and CEO of Pluristem. “We are honored to collaborate with the Hospital and the Berlin-Brandenburg Center for Regenerative Medicine (BCRT).” Mr. Aberman also stated: “Signing an agreement with the Franziskus-Krankenhaus Hospital is also very appropriate, due to the Hospital’s considerable experience and expertise in human stem cell studies in peripheral artery disease (PAD).”
About BCRT
The Berlin-Brandenburg Center for Regenerative Therapies (BCRT), an integral part of Charité Universitätsmedizin, Berlin, one of Europe’s largest university hospitals, located within Europe’s leading biotechnology region, developed an internationally visible center of excellence in regenerative medicine with a focus on targeted cell differentiation for promoting endogenous tissue regeneration and translating basic science discoveries into regenerative therapies. The BCRT is also sharing its scientific knowledge in regenerative medicine with researchers, clinicians, industry and the public through educational activities, training, publications, and communication forums at national and international levels.
About Franziskus Hospital
Franziskus Hospital, managed by the Sisters of the Franziskus Order and located in Berlin, is a medical and teaching hospital dedicated to the treatment of vascular disorders. It is composed of three main departments: Vascular Medicine, Surgery and Intervention. With approximately 180 beds, Franziskus Hospital is Germany’s largest vascular center with more than 15,000 patients per year treated for venous or arterial disorders. The hospital has a unique focus on the cell-based therapy of arterial occlusive disease.
About Critical Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with peripheral artery diseases (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, 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.
About Pluristem
Pluristem Therapeutics Inc. is a 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. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriXTM 3D bioreactor, which imitates the natural 3D microenvironment of these cells and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells’ efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and possess 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-IBD, targeting Inflammatory Bowel Disease (IBD); PLX-MS, targeting Multiple Sclerosis; PLX-BMT, 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; and PLX-STROKE, targeting ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel. |
