Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, has received the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA) approval for its 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.”
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.
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).
CHA Bio&Diostech Co., Ltd. is a leading biopharmaceutical company; 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.