PSTI’s meeting with the Paul Ehrlich Institute (NYSE:PEI), the German regulatory authority for advanced therapy products (ATP) allows designing 2 Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia (NYSE:CLI) and Moderate-severe Claudication.
PSTI has also received approval for a government grant in the amount of $2.5M from the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of Israel, as government participation in R&D expenses. This is the 5th consecutive year that Pluristem has received this grant.
2 Phase IIb studies will further evaluate the safety and efficacy of PLX-PAD in patients suffering from CLI, the end stage of peripheral artery disease (PAD), and Moderate-severe Claudication. In the US, there is a significant unmet medical need for an effective and economical treatment for both conditions, which have an estimated national cost of $14.3B annually, based on inpatient hospital bills.