New York, N.Y.-based Pluristem Therapeutics Inc. (NasdaqCM: PSTI) said on January 8 that it has identified a second clinical indication for its proprietary PLX 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 peripheral artery disease (PAD).
“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,” CEO Zami Aberman said. “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 more than $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 8-12 million people in the United States suffer from limb ischemia associated with PAD, the company said.
The disease is characterized by narrowing and hardening of the arteries in the patient’s limbs caused and/or aggravated by diabetes, Buerger’s disease, other diseases and smoking.
Pluristem is dedicated to the commercialization of non-personalized (allogeneic) stem cell therapy products for the treatment of numerous severe degenerative, malignant and autoimmune disorders.
PLX-I is directed at resolving 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 (UCB).