HAIFA, Israel, Jan. 15, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-derived cell therapies, announced today that the Paul-Ehrlich-Institute (PEI), the medical regulatory body for biological medicinal products for the Federal Republic of Germany, has approved the company's request to initiate a Phase II study using PLX-PAD cells in patients suffering from Intermittent Claudication (IC). IC is a subset of Peripheral Artery Disease (PAD). According to The SAGE Group and HCUP 2007 Inpatient Data, the prevalence of IC in the United States is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the healthcare system.
"This approval is part of our previously announced strategy to conduct a multi-national study using our PLX-PAD cells in this disorder," said Zami Aberman, Chairman and CEO of Pluristem. "We are in the process of opening three clinical sites in Germany where the protocol will be same as the one used in the U.S. which has already begun enrolling and dosing patients. Additionally, we plan to expand into clinical sites in Israel, following regulatory approval."
About the StudyPluristem's IC Phase II is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is comprised of approximately 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).