Pluristem Moves Intermittent Claudication Indication Forward in Europe Through Collaboration With Cato Research
HAIFA, Israel, Aug. 13, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it has selected Cato Research as its contract research organization (CRO) for the German portion of the Company's Phase II trial in intermittent claudication (IC) under the auspices of the Paul-Ehrlich Institute (PEI). Cato will serve as Pluristem's applicant for its IC Clinical Trial Application to the PEI and to the ethics committees of the three study sites where the trials will be conducted. The trial will evaluate the safety and efficacy of Pluristem's PLacental eXpanded (PLX-PAD) cells in treating IC, a subset of peripheral artery disease (PAD). The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the healthcare system. (References: The SAGE Group and HCUP 2007 Inpatient Data)
Cato Research is a full-service contract research and development organization with international resources. Cato is dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in bringing new drugs, biologics, and medical devices to the people who need them.
In addition to Germany, Pluristem's multinational Phase II trial in IC will also include 11 sites in the United States and 2 sites in Israel with the US Food and Drug Administration (FDA) already approving the United States portion of this study. The trial will enroll 150 patients in a randomized, double blinded, placebo controlled study evaluating two doses of either 150 or 300 million PLX cells given intramuscularly three months apart. The primary endpoint of the trial will be maximum walking distance achieved on a treadmill at 12 months.
"Cato is a global organization with sixteen offices around the world, seven of which are in Europe. If we choose to open more clinical sites in the European Union, Cato has the resources to support us efficiently with the regulatory submission to the different regulatory agencies," stated Zami Aberman, Chairman and CEO of Pluristem. "IC afflicts approximately 14 million people in the United States alone. If we are successful in our trials, our proprietary 3D technology for manufacturing our PLX-PAD 'off-the-shelf' product will enable us to meet the demand to treat such a large population of patients across the world."
About Intermittent Claudication:
Intermittent Claudication (IC) is a subset of Peripheral Artery Disease (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 Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) 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 is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.
Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-RAD for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.
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