Haifa, Israel -- (SBWire) -- 07/09/2013 --On the heels of announcing its strategic partnership agreement with Cha Bio&Diostech on June 26th, Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that Cha Bio&Diostch “Cha” has filed its first investigational new drug (IND) application for Pluristem’s PLacental eXpanded (PLX) cells with the Korea Food and Drug Administration (FDA). This IND is for the use of PLX-PAD in the treatment of intermittent claudication (IC) and mirrors the clinical protocols implemented by Pluristem in its U.S. FDA 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.
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 Korea FDA. 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.
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 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, when we discuss the review process of IND applications by the Korean FDA, we are using forward-looking statements. 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.
Pluristem's South Korean Partner Files IND with Korean FDA for PLX Cells