Pluristem Therapeutics (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Israel’s Ministry of Health has cleared the Company to commence patient recruitment in Israel for two ongoing pivotal Phase III trials of PLX-PAD cell therapy, one for the treatment of Critical Limb Ischemia (CLI) and another for the treatment of muscle injury following hip fracture surgery. Both trials have been accepted to accelerated approval pathways and have received a total of $16.7 million in grants from the European Union’s Horizon 2020 Program.
As quoted in the press release:
“We are pleased to open clinical sites in Israel for both of our ongoing pivotal Phase III studies. These sites may enable Pluristem to apply for marketing approval in Israel for both indications, aligning with potential regulatory approvals in the U.S. and Europe and expedite the completion of recruitment of both pivotal trials,” stated Pluristem Chairman and Co-CEO, Zami Aberman.
Pluristem’s pivotal Phase III study of PLX-PAD cells in the treatment of CLI, which has received an $8 million grant from the European Union’s Horizon 2020 program, and is currently recruiting patients in the U.S., U.K., Germany, Poland, Czech Republic, Hungary, Bulgaria and Macedonia. PLX-PAD has received the U.S. Food and Drug Administration’s (FDA) Fast Track designation for the treatment of CLI and has been included in the European Medicines Agency (EMA) Adaptive Pathways program, which may lead to early conditional marketing authorization based on an interim analysis following treatment of half of the total 246 patients to be enrolled in the study. The FDA recently cleared PLX-PAD for its Expanded Access Program (EAP) for the treatment of patients with CLI who are not eligible for Pluristem’s Phase III study. EAP allows the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
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