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.
Pluristem Therapeutics Inc., a leading bio-therapeutics Company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of malignant, ischemic, and autoimmune disorders, announced that it has identified a second clinical indication for its proprietary PLX (PLacenta eXpanded) cells and the expansion of its pipeline of PLX products. Pluristem’s PLX-PAD is expected to begin clinical trials in the second half of 2008 in Europe for the treatment of limb ischemia associated with PAD.
Pluristem’s Chairman and CEO, Zami Aberman, commented: “The consistent impressive results we are obtaining in our pre-clinical in vivo studies with PLX-PAD suggest this cellular therapy may be the first allogeneic, off-the-shelf product to successfully treat this serious disease.” Mr. Aberman added: “We are pleased that PLX-PAD will join PLX-I, our first product used as an alternative to bone marrow transplantation for treating hematological malignancies, in building a meaningful pipeline of PLX products.”
Scientists have confirmed that studies in animals whose hind legs were rendered ischemic using standard industry methodologies, post-treatment evaluation using laser Doppler technology indicated revascularization of the limbs treated with PLX-PAD cells but not in those limbs not treated with PLX-PAD. Additionally, immunohistochemical analyses of those limbs treated with PLX-PAD indicated a significant increase in the number of new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the ability to promote angiogenesis (new vessel formation).
Pluristem plans to initiate Phase I clinical trials using PLX-PAD in Europe in the second half of 2008 in collaboration with a major clinical research institution. 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.
Illustration: Pluristem Therapeutics, Inc.
Business Wire (01/08/08)
Genetic Engineering & Biotechnology News (01/08/08)
Trading Markets (01/08/08)
Wall Street Journal (01/08/08)
Pluristem Therapeutics Inc.