2017 will be a significant year for Pluristem (NASDAQ:PSTI) as the company expands its clinical program with a transnational Phase III clinical trial of PLX-PAD for critical limb ischemia (CLI). Pluristem recently put protocols in place in the US and Europe with plans to initiate in the first half of 2017. Additionally, it continues to make progress in its intermittent claudication (IC) Phase II clinical trial, which was fully enrolled as of January 2017, with data expected in early 2018.
Ready to go for CLI
The medical authorities in the US, UK, and Germany have now signed off on Pluristem’s clinical trial protocol for CLI. This is significant, because as it is designed, the trial should allow for approval in all territories with a single 250-person study. The endpoint for the study will be improvement in time-to-event, which should improve the statistical analysis enabling the small trial size. The study should start in the first half of CY17.
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