Pluristem Therapeutics

Pluristem Receives Clearance from South Korea to Use PLX Cells Manufactured at Its New Facility in Its Advances Studies

CEO Zami Aberman to Present at BIO KOREA 2014 on May 29

 

Haifa, Israel -- (ReleaseWire) -- 05/23/2014 -- Pluristem Therapeutics Inc., 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.

About Pluristem's 3D Manufacturing
Pluristem's state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support late-phase clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem's manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration, the Paul-Ehrlich-Institute (PEI) of Germany, and European Union's Qualified Person.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit http://www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss our planned clinical trials for IC in South Korea or when we discuss receiving regulatory approval for PLX products in South Korea. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.