Israeli placenta-based cell therapy product developer Pluristem Therapeutics Ltd. (TASE: PSTI; Nasdaq:PSTI) announced today that it has been awarded an $8.7 million (€7.4 million) grant from the EU. The grant from the EU R&D Horizon 2020 program is for the Haifa based company's Phase III study of PLX-PAD cells to support recovery following surgery for femoral neck (hip) fracture. Final approval of the grant is subject to the finalization of the consortium and Horizon 2020 grant agreements. This is the second such grant won by a Pluristem Phase III trial from Horizon 2020, following an $8 million (€7.6 million) award for its ongoing Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI), which was given in August 2016.
The Phase III trial of PLX-PAD cells in the treatment of femoral neck fracture will be a collaborative effort between Pluristem and an international consortium led by the Charité – Universitätsmedizin Berlin, under the leadership of Dr. Tobias Winkler, Principal Investigator at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Dr. Winkler also served as Senior Scientist for Pluristem’s completed Phase I/II study of PLX-PAD for hip surgery. That trial demonstrated that patients treated with Pluristem’s PLX-PAD cells during total hip arthroplasty experienced significant muscle regeneration compared to the control group with an improvement in muscle force and in muscle volume six months after surgery.
Dr. Winkler said, “Following the impressive results from the Phase I/II study of PLX-PAD cells in a similar orthopedic indication, we are excited to advance PLX-PAD cell therapy into a Phase III study to aid in muscle regeneration in patients recovering from femoral neck fracture. If similar results are achieved in this Phase III trial, it could show that PLX-PAD cells can improve outcomes in these procedures and change the way recovery is managed worldwide.”
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs are estimated to be between $10-$15 billion in the US alone. The number of surgeries performed annually to treat femoral neck fractures is increasing as populations age. Following surgery, many patients do not regain their baseline capabilities due to poor muscle healing and regeneration, which leads to significantly increased morbidity and a lower quality of life.
Pluristem chairman and CEO Zami Aberman said, “We are honored to receive this second grant from the Horizon 2020 program. We believe this grant reflects a vote of confidence by the EU and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens. We are confident that this grant will help us move towards rapid entry into the European and US markets.” Pluristem’s PLX-PAD program is one of only a handful to be accepted into Europe’s Adaptive Pathway program, the purpose of which is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. Pluristem plans to enroll patients at clinical sites throughout Europe and the US. The study is expected to serve as a pivotal trial for regulatory approval in both regions.
Published by Globes [online], Israel business news - www.globes-online.com - on September 6, 2017
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