HAIFA, Israel, May 20, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced the latest advancement in its clinical and commercial development programs in South Korea. 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 U.S., Israel and Germany.
“South Korea is a large market in which we are very well positioned due to our 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,” stated Pluristem Chairman and CEO Zami Aberman.
Mr. Aberman will present at BIO KOREA 2014, which will take place in Goyang, South Korea on May 28th through May 30th. His presentation titled, “Cell Therapy – From the Bench to Multi-National Clinical Studies,” will take place during the “Stem Cell & Regenerative Medicine” track on May 29th at 2:50 pm. During the presentation, Mr. 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 (Kosdaq:CHA) 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 (JV) co-owned by the parties.
According to market research firm Clearstate, 1 million people in South Korea suffer from PAD and the growth forecast for the number of people diagnosed and treated in the country is moderate-to-high.
