Cell therapy company Pluristem Therapeutics has received funding to launch a phase three trial for the treatment of Critical limb ischaemia (CLI).
CLI is an advanced stage of peripheral artery disease. Fatty deposits block arteries in the legs, severely reducing blood flow and causing pain, non-healing ulcers and gangrene.
Patients with CLI are at a high risk of amputation and death, and those unsuitable for revascularisation are left with no adequate treatment options.
Pluristem, based in Haifa, Israel, is a developer of placenta-based cell therapy products and is involved in a pivotal trial of its product PLX-PAD cells, which is used to treat CLI.
The trial is currently enrolling participants in the US, the UK and Germany. Austria’s Agency for Health and Food Safety recently cleared the company’s CLI study so other Europeans may participate in the 250 patient trial.
The company is hoping to have 40 active sites by the end of 2017.
Pluristem’s PLX-PAD cell therapy is one of a few therapies in the world to have been selected to take part in the European Medicines Agency’s (EMA) Adaptive Pathways pilot project. The project’s goal is to streamline development for promising innovative medicines to allow for early access to patients with serious conditions who lack adequate treatment.
Zami Aberman, chairman and co-CEO of Pluristem, said: “CLI is a severely debilitating and life-threatening disease that affects tens of millions of patients around the world. Approval for this trial and its innovative time-to-event endpoint by regulatory bodies worldwide reinforces our belief that our PLX-PAD cell therapy has great potential to successfully treat these patients and enable them to lead long and healthy lives.”
The trial has received an $8m (~€6.8m) grant under the Horizon 2020 programme to cover a significant portion of the costs of the multinational trial.
Following the completion of the study, data from all 250 participants will be submitted to the EMA to apply for full marketing approval in Europe.