The Israeli Ministry of Health (IMH) has approved Pluristem Therapeutics’ request to start a Phase II trial using its PLacental eXpanded (PLX) cells in the treatment of intermittent claudication (IC).
IC is a subset of peripheral artery disease caused by atherosclerosis of the lower extremity arteries.
The randomized, placebo-controlled Phase II trial has been designed to assess the safety and efficacy of two doses of PLX-PAD cells compared to placebo, administered through intramuscular injections.
The company will follow the same protocol that has been approved and used in the US study for the new Phase II study in Israel. The protocol is comprised of around 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.
Change in the maximal walking distance from baseline during an exercise treadmill test will be the primary efficacy end point, while hemodynamic and quality of life measurements will be the secondary endpoints.
Pluristem Therapeutics chairman and CEO Zami Aberman noted the company is excited to receive the Ministry of Health approval for its clinical study in Israel.
"This also marks the first clinical study in Israel to use off-the-shelf allogeneic, placental-derived cells. Additionally, the professional review of this clinical trial application by the Israeli Ministry of Health will provide a solid foundation for Pluristem to conduct additional studies in Israel," Aberman added.
