Pluristem Therapeutics, Inc. (NASDAQ: PSTI), a leading Israel-based developer of placenta cell therapies for various ailments including ischemia, inflammation, radiation damage and hematology disorders, recently secured an $8 million grant from the European Union for its critical limb ischemia (CLI) program, according to a news release (http://nnw.fm/YvNo5) issued August 9.
The CLI grant, offered under the EU’s largest research and innovation program, Horizon 2020, will cover a significant portion of Pluristem’s PLacental eXpanded (PLX) PAD cells study, which will enroll about 250 U.S. and European patients suffering from CLI Rutherford Category 5. This category of patients is commonly unsuitable for the typical CLI treatment based on revascularization. The subjects will take part in a randomized, double blind, placebo controlled trial in which they will be given two intramuscular injections with 300 million cells or placebo, two months apart.
Pluristem intends to use the study as a pivotal trial to secure regulatory approval in both Europe and the U.S. If successful, the PLX-PAD cells treatment will mark a breakthrough on the global CLI market, which is currently estimated at $12 billion. The end goal of the company is to develop an off-the-shelf product that can be delivered in virtually any clinical setting and would not require tissue or genetic matching before administration. PLX cells products are developed based on the company’s proprietary 3D expansion technology.
“We are honored to have been awarded this Horizon 2020 grant designed to support the manufacturing and development of our cell products for potential commercialization,” Pluristem CEO Zami Aberman stated in the news release. “This grant is a vote of confidence and an expression of hope by the European Union that we may be able to provide a regenerative therapy for millions of CLI patients around the world.”
The phase III study will be carried out by an international consortium bringing Pluristem together with the Berlin-Brandenburg Center for Regenerative Therapies, under the leadership of reputable Professors Petra Reinke and Hans-Dieter Volk. The consortium will conduct an extensive scientific research program that will use in-depth molecular, endocrine and immunological analyses with the purpose of better understanding how Pluristem’s product candidate works in patients with CLI.
Pluristem’s PLX-PAD has already been selected for the European Union’s Adaptive Pathways project, which is designed to help shorten the time it takes innovative therapies to reach patients that lack other treatment options.
For more information, visit www.Pluristem.com
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