PSTI
HAIFA, Israel, June 04, 2018 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. ( PSTI) ( PSTI.TA), a leading developer of placenta-based cell therapy products, today announced that the top-line results of the company’s multinational Phase II clinical trial of PLX-PAD cells in the treatment of Intermittent Claudication (IC) will be released on June 12, 2018.
<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm" style="margin-bottom: 15px; margin-left: 0px; margin-right: 0px; margin-top: 0px;" type="text" data-reactid="12" content="Pluristem's Phase II IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo in 172 patients with IC, Rutherford category 2-3. Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea and Israel. Patients received either two courses of 150 ×106 PLX-PAD cells, two courses of 300 ×106 cells, two courses of placebo, or one course of 300 ×106 cells followed by placebo. In each of these study arms, the two courses were given intramuscularly, 3 months apart. The primary efficacy endpoint is the change in maximal walking distance one year after the first administration. Other endpoints include rate of revascularization and other hemodynamic and clinical parameters.">Pluristem's Phase II IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo in 172 patients with IC, Rutherford category 2-3. Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea and Israel. Patients received either two courses of 150 ×106 PLX-PAD cells, two courses of 300 ×106 cells, two courses of placebo, or one course of 300 ×106 cells followed by placebo. In each of these study arms, the two courses were given intramuscularly, 3 months apart. The primary efficacy endpoint is the change in maximal walking distance one year after the first administration. Other endpoints include rate of revascularization and other hemodynamic and clinical parameters.
IC is a subset of peripheral artery disease (PAD). It is caused by obstruction to arterial flow in the legs and is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. Almost fifth of the population over the age of 65 has IC and as a result of demographic changes in many developed countries, its prevalence in the general population is likely to rise dramatically over the next 20 years. PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities. |
