Pluristem Therapeutics (PSTI) PLX Cells IND Submitted to Korean FDA
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On the heels of announcing its strategic partnership agreement with Cha Bio&Diostech on June 26th, Pluristem Therapeutics Inc. (Nasdaq: PSTI) announced that Cha Bio&Diostech "Cha" 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 IND is for the use of PLX-PAD in the treatment of intermittent claudication (IC) and mirrors the clinical protocol implemented by Pluristem in its FDA supervised Phase II IC clinical trial in the United States.
"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," stated Zami Aberman, Chairman and CEO of Pluristem. "We anticipate working closely with Cha to initiate this Phase II trial in intermittent claudication as soon as possible."
Pluristem recently announced that under the terms of its agreement with Cha, Cha will perform and fund multiple clinical trials in South Korea for treating critical limb ischemia (CLI) and IC using PLX-PAD under the supervision of the KFDA. Upon the first regulatory approval for a PLX product in South Korea, Pluristem and Cha will establish a joint venture (JV) co-owned by the parties. The purpose of the JV will be to commercialize PLX cell products in South Korea. According to market research firm Clearstate, 1 million people in South Korea have PAD and the growth forecast for the number of people diagnosed and treated in the country is moderate-to-high.
"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," stated Zami Aberman, Chairman and CEO of Pluristem. "We anticipate working closely with Cha to initiate this Phase II trial in intermittent claudication as soon as possible."
Pluristem recently announced that under the terms of its agreement with Cha, Cha will perform and fund multiple clinical trials in South Korea for treating critical limb ischemia (CLI) and IC using PLX-PAD under the supervision of the KFDA. Upon the first regulatory approval for a PLX product in South Korea, Pluristem and Cha will establish a joint venture (JV) co-owned by the parties. The purpose of the JV will be to commercialize PLX cell products in South Korea. According to market research firm Clearstate, 1 million people in South Korea have PAD and the growth forecast for the number of people diagnosed and treated in the country is moderate-to-high.
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