CHA Bio Will Conduct and Fund the Trial; PLX-PAD Cells Are the First Placental-Derived Allogeneic Cells Approved for Importation Into South Korea
Haifa, Israel -- (SBWIRE) -- 11/15/2013 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA), has approved Pluristem's Investigational New Drug (IND) Application to conduct a Phase II study using PLX-PAD cells for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).
The IND approved by the MFDS mirrors INDs already approved by regulators in the USA, Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech Co., Ltd., Pluristem's South Korean partner, will fund the trial and conduct it in its healthcare facilities.
"Pluristem's ability to extend our Phase II study of IC into South Korea is important for several reasons," commented Zami Aberman, Pluristem's Chairman and CEO. "Partnering with CHA Bio to conduct the clinical trial in their hospitals will accelerate the enrollment and strengthen our relationship with our South Korean partner. Additionally, Pluristem is proud of the fact that our PLX-PAD cells are the first placental-derived allogeneic cells allowed to be imported into South Korea. We at Pluristem believe this is a validation of Pluristem's expertise in cell therapy in general and PLX potential cell therapy in particular."
About the Study
Pluristem's Phase II study of IC is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two courses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol targets enrollment of 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.
The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
About Intermittent Claudication
IC is a subset of PAD caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue classically in the calf muscle, which occurs during exercise, such as walking, and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients and representing a cost of approximately $2.5 billion annually to the National Healthcare Bill (References:The SAGE Group and HCUP 2007 Inpatient Data).
About CHA Bio&Diostech
CHA Bio&Diostech Co., Ltd. is a leading biopharmaceutical company headquartered in South Korea; its R&D focuses on stem cells, cell therapeutics, medical device, and new drug development. The company is a member of CHA Health Systems Group, which is comprised of a medical university, medical centers and hospitals located in the US and Korea with in excess of two thousand beds under care, stem cell research centers, personal & preventive medicine, and bio venture divisions. CHA Bio&Diostech has multiple stem cell R&D pipelines in therapeutic areas including Stargardt's disease, age-related macular disease, Parkinson's disease, Alzheimer disease, Cerebral Palsy and glioblastoma in mid- to late-stages of development. With its extensive experience and research infra structure, CHA Bio&Diostech has built up multiple strategic relations with major research institutions in the fields of stem cell research and infertility. For more information visit www.chabio.com, the content of which is not part of this press release.
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, when we discuss the planned IC trial in South Korea, or when discuss our belief that the fact that PLX cells are the first placental-derived allogeneic cells allowed to be imported into South Korea validates Pluristem's expertise in cell therapy in general and PLX potential cell therapy in particular, 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.