Pluristem Successfully Concludes Final Pre-Clinical Safety Studies with PLX-PAD in Preparation for Human Trials
News Sep 12, 2008
The final studies involved 150 animals that received single, repeated intra-muscular (IM) injections of PLX-PAD or a control substance then followed for up to 3 months post-injection. No adverse effects were noted to be caused by the PLX-PAD injections throughout the study period. Moreover, all the histology, hematology and biochemistry panels and biodistribution results support the safe administration of PLX-PAD.
Previously, the Company had reported that in animals whose hind legs were rendered ischemic (reduction in blood flow) using standard industry methodologies, post-treatment evaluation using laser Doppler technology indicated revascularization (return of blood flow) of the limbs treated with PLX-PAD but not in those limbs not treated with PLX-PAD. The affected limbs’ function also improved in those animals receiving PLX-PAD. Additionally, microscopic analyses of those limbs treated with PLX-PAD indicated a statistically significant increase in the number of new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the ability to promote angiogenesis (new vessel formation).
Zami Aberman, Pluristem’s President and CEO commented, “The successful completion of the PLX-PAD pre-clinical phase, in accordance with the regulatory authority's requirements, is a major milestone. This was our final study using our PLX-PAD. We now intend to commence human trials, following receipt of the required regulatory approvals. The impressive results we have obtained in these studies give us confidence that we will be able to prove safety in our planned US and European dose escalation Phase I/II human studies, followed by proof of efficacy in our later trials.”
Pluristem Therapeutics the bio-therapeutics company dedicated to the commercialization of non- personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications