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Pluristem’s (PSTI) $8 M Grant from Europe’s Horizon 2020 Program for P3 CLI study

August 9, 2016 9:18am

The grant will cover a significant portion of the trial/study expenses - BUY

PSTI’s critical limb ischemia (CLI) program in the European Union has been awarded an $8 M grant. The grant is part of the European Union’s Horizon 2020 program, which is its largest Research and Innovation program.

The P3 study of PLX-PAD in CLI will be a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) under the leadership of Prof. Hans-Dieter Volk and Prof. Petra Reinke together with Pluristem.

The pivotal study for Pluristem’s PLacental eXpanded (PLX) PAD cells in the treatment of CLI is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), and with the second dose administered two months after the first.

The Bottom Line: The mechanism of action of PLX-PAD in CLI is still not fully understood and the primary endpoint will be time to amputation and death.

Patients will be enrolled in clinical sites located throughout the EU and the U.S. PSTI’s intention is to utilize this study as a single pivotal trial for regulatory approval in both regions.

PSTI closed at $1.51 and should be UP as the market opens. Watch for a financing to be initiated.

The EU’s Adaptive Pathways project’s goal is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options.

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