Pluristem receives South Korean clearance to use PLX in advances studies

The South Korean Ministry of Food and Drug Safety (MFDS) has recently cleared Pluristem’s upgraded manufacturing process in its new facility in Haifa, Israel. The cells produced at Pluristem new facility will be used by Korean sites joining the large Phase II study currently conducted by Pluristem in intermittent claudication (IC) patients. This Phase II IC study is currently ongoing in the US, Israel and Germany.

Pluristem chairman and CEO Zami Aberman said that South Korea is a large market in which the company is very well positioned due to its strategic partnership agreement with CHA Bio & Diostech.

"We believe that our PLX cells are the only allogeneic cellular therapy product approved for clinical trials in South Korea. With the MFDS’s clearance for our cell manufacturing processes, we are now pleased to move forward with our Phase II IC trial in Korea," Aberman added.

Aberman will present at BIO KOREA 2014, which will take place in Goyang, South Korea on 28 May through 30 May 2014. His presentation titled, ‘Cell Therapy – From the Bench to Multi-National Clinical Studies’, will take place during the ‘Stem Cell & Regenerative Medicine’ track on 29 May. During the presentation, Aberman will discuss the collaborative clinical and commercial development process jointly undertaken by Pluristem and CHA.

Pluristem is operating in the South Korean market through an exclusive out-license and strategic partnership agreement with CHA Bio & Diostech for the use of its Pluristem’s PLacental eXpanded (PLX) cells for peripheral artery disease (PAD), in South Korea.

Under the terms of the agreement, CHA will perform and fund multiple clinical trials in South Korea using Pluristem proprietary PLX cells. Upon the first regulatory approval for a PLX product in South Korea, Pluristem and CHA will establish a joint venture co-owned by the parties.