International study extends FDA P2 trial that began in U.S.
PSTI’s Israeli Ministry of Health has approved the company’s request to initiate a Phase II study using its PLacental eXpanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). This approval is part of the company’s previously announced strategy to conduct a multi-national study for this indication. The protocol will be the same one used for the study previously approved in the U.S.
PSTI’s IC P2 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.
PSTI closed at $3.45 and is UP +$0.09 or +2.51% in the pre-market <but, can it last as news has a 1-2 day shelf life>. In the past weeks, PSTI has had a stagnant share price, alternating from $3.22 to a high of $3.48.
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).
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