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news.Pluristem Therapeutics, a bio-therapeutics company, has received approval from Biotec Services International, an international clinical trials supply company, stating that Pluristem's investigational medicinal product, PLX-PAD, is manufactured in accordance with standards of good manufacturing practice or GMP, equivalent to those applied in the EU.
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Upon investigational new drug and investigational medicinal product dossier clearance by the regulatory authorities, Pluristem plans to initiate clinical trials in Europe and in the US, administering PLX-PAD to patients afflicted with critical limb ischemia, which has not responded to traditional medical or surgical interventions.
Zami Aberman, chairman, president and CEO of Pluristem, said: “We have invested approximately $2 million at Pluristem, building a state of the art facility and training our team to manufacture our cell therapy product, PLX-PAD. The successful audit of the manufacturing site by a qualified person from the UK is assurance that our product is manufactured as required under good manufacturing practice standards.”