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Pluristem Therapeutics Inc, a bio-therapeutics company dedicated to the commercialisation of nonpersonalised (allogeneic) cell therapy products for a variety of degenerative, ischaemic and autoimmune indications, have announced that the Paul Ehrlich Institute (PEI) in Germany has approved the pre-clinical study synopsis to support phase I/II clinical trials in Germany of the PLX-PAD for the treatment of limb ischaemia associated with peripheral artery disease (PAD).
The PEI is the German federal authority granting clinical trial approvals.
In the USA, the Center for Biologics Evaluation and Research (CBER) – a division of the US Food and Drug Administration (FDA) – has approved the synopsis to conduct a phase I clinical trial.
PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX technology
The regulatory and scientific package submitted to both authorities contains detailed information on the clinical indication, product properties, the Good Manufacturing Practices (GMP) manufacturing process for the production of PLX-PAD, and the clinical protocol synopsis for the planned phase I/II clinical trial.
The package also contains information on the safety and biodistribution study designs required to file an investigational new drug (IND) application.
Mr Zami Aberman, Pluristem’s President and CEO, said: “I am proud that our team has accomplished this important milestone in achieving the FDA and PEI approval of our clinical route.
“We believe that this now paves the way to submit an IND using PLX-PAD for limb ischemia this summer and hopefully begin our phase I/II clinical trials in 2008.”
Converting the miracle of birth to therapeutic (computer animation)