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news.Pluristem Therapeutics, a bio-therapeutics company, has completed its pre-clinical studies utilizing PLX-PAD prior to the initiation of human clinical trials. PLX-PAD is Pluristem's cellular product for the treatment of critical limb ischemia, the end phase of peripheral artery disease.
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The final studies involved 150 animals that received single, repeated intra-muscular injections of PLX-PAD or a control substance then followed for up to three 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, said: “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.”