Pluristem Therapeutics Inc. Announces Filing an IMPD to Commence Clinical Trials Utilizing PLX-PAD for Critical Limb Ischemia in Europe
News source: Business Wire
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non- personalized (allogeneic), off-the-shelf, cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that it has filed an Investigational Medicinal Product Dossier (IMPD) application with the Paul Ehrlich Institute (PEI), the German competent authority in the European Union (EU), to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI). Assuming approval of the IMPD by this authority, Pluristem plans to initiate the dose ranging clinical trial during the second quarter of 2009 at two sites in Berlin, Germany. The patient population for this initial clinical trial will be considered "late stage", defined as patients whose limb ischemia has not responded to traditional medical or surgical interventions and are facing amputation. Pluristem also plans to file shortly an Investigational New Drug (IND) application with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), for a similar trial to take place in two US clinical centers.
"We are excited about filing an IMPD for PLX-PAD, bringing us closer to initiating our clinical trial in critical limb ischemia in Europe," said Zami Aberman, President & CEO of Pluristem. "Our primary goal for this trial, as well as for the one we will begin in the US, is to prove PLX-PAD is safe. If we are successful in this endeavor, it will have been the first time adult stem cells, derived from placenta and grown using our PluriXTM 3D technology, have been administered to humans safely. We believe successful trials in Europe and the US herald the dawn of a new era in the evolving industry of cellular therapeutics – being able to administer an allogeneic, off-the-shelf product that needs no matching."
Results of preclinical studies in animal models whose limbs were rendered ischemic, using intramuscular (IM) administration of PLX-PAD, have shown a statistically significant increase in blood flow and formation of new blood vessels (angiogenesis) (P<0.05). Pluristem believes the primary mechanism underlying the potential efficacy of PLX-PAD is one of immune modulation rather than cellular differentiation, a hypothesis also supported by the Company’s preclinical data.
About CLI
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 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. Industry experts have estimated that the market for therapeutics used in the treatment of limb ischemia to be over $1 Billion. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led the medical community to call for the development of cellular therapies, such as Pluristem’s PLX-PAD, as alternative treatments.
About an IMPD
An Investigational Medicinal Product Dossier (IMPD) is a harmonized procedure for the authorization to perform a clinical study in any one of the EU Member States. An IMPD is requested whenever the performance of a clinical study in any one of the EU Member States is intended, and it is similar to an Investigational New Drug (IND) Application that would be filed for the performance of a clinical study in the United States.
The IMPD includes information related to the quality, manufacture and control of the Investigational Medicinal Product, data from pre-clinical studies and clinical intent-to-use. An overall risk-benefit assessment, critical analyses of the pre-clinical data in relation to the potential risks and benefits of the proposed study are required to be part of the IMPD.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic), off-the-shelf, cell therapy products, for which no matching is needed, 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 critical limb ischemia (CLI) as an end result of 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.
See our product animation on YouTube: youtube.com |
