The company also reported that the Center for Biologics Evaluation and Research (CBER), a division of the FDA, has approved the synopsis to conduct a Phase I clinical trial in the US utilizing PLX-PAD for the treatment of limb ischemia associated with peripheral artery disease (PAD).
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.
PLX-PAD are mesenchymal stromal cells obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX technology. The Paul Ehrlich Institute (PEI) is the German federal authority granting clinical trial approvals.
Zami Aberman, Pluristem’s president & 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.”