Cha Bio&Diostech, a South Korean partner of Pluristem Therapeutics, has filed its first investigational new drug (IND) application for Pluristem’s PLacental eXpanded (PLX) cells with the Korean Food and Drug Administration (KFDA).
This announcement comes, following a strategic alliance inked on 26 June 2013 between Cha and Pluristem Therapeutics, which is a developer of placenta-based cell therapies.
As per the IND application, the PLX-PAD will be used in the treatment of intermittent claudication (IC) and it reflects the clinical protocol implemented by Pluristem in its FDA supervised Phase II IC clinical trial in the US.
Commenting on Cha's move, Pluristem chairman and CEO Zami Aberman said, "Having just concluded our alliance with Cha, we are very pleased with the pace at which our new partner is moving forward towards clinical trials in South Korea."
"We anticipate working closely with Cha to initiate this Phase II trial in intermittent claudication as soon as possible," Aberman added.
As per the terms of the agreement inked last month, the South Koran company will perform and fund multiple clinical trials in the country for treating critical limb ischemia (CLI) and IC using PLX-PAD under the supervision of the KFDA.
Following KFDA approval, both companies have agreed to set up a joint venture (JV) to commercialize PLX cell products in South Korea.