Pluristem Therapeutics Inc (PSTI)

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BREAKING NEWS ! ABSTRACT HAS JUST BEEN RELEASED !

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Saturday, 11/10/18 11:04:54 AM
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BREAKING NEWS ! ABSTRACT HAS JUST BEEN RELEASED !


http://www.abstractsonline.com/pp8/#!/4682/presentation/59958


Consultant/Advisory Board; Modest; AstraZeneca, Bayer, Janssen.AbstractBackground: Intermittent claudication (IC) due to peripheral arterial disease impairs function and quality of life. Limited non-invasive therapies exist. Previous angiogenesis trials to improve IC were negative. Intramuscular administration of placenta-derived adherent stromal (PLX-PAD) cells increased angiogenesis and blood flow in a murine hind-limb ischemia model, and was demonstrated to be safe in clinical phase I studies. The aim of this phase II study was to evaluate the optimal dosing regimen, efficacy and safety of intramuscular PLX-PAD cells in patients with IC, Rutherford categories 2-3, due to femoropopliteal disease (NCT01679990).
Study Design: This randomized, double-blind, placebo-controlled, multicenter study included 180 IC patients (65.6±8.6 years, 22.2% female), randomized into four arms, each treated twice, 3 months apart: 300×106 cells twice, 150×106 cells twice, 300×106 cells once followed by placebo once, and placebo twice. Each administration consisted of 30 injections into the thigh and calf musculature. Primary efficacy endpoint was Maximal Walking Distance (MWD) at week 52 compared to baseline, determined by a standardized treadmill test. Values were Log transformed to reduce deviation from the normal distribution. Key secondary endpoint was the ratio of week 52 MWD to baseline in patients treated with 2 doses of PLX-PAD cells originating from different placentae.
Results: Mean MWD at baseline was 293±138 sec. Patients treated per protocol with two administrations of 300×106 PLX-PAD cells showed a 44% improvement in MWD at 52 weeks compared to baseline (Table). Two administrations of 300×106 cells were significantly superior to a single administration. No arm showed a statistically significant difference from placebo. Patients treated with 2 doses of 300×106 cells originating from different placentae showed a statistically significant 42% difference in MWD at week 52 compared to patients receiving placebo, and also demonstrated a statistically significant 83% improvement in MWD at 52 weeks compared to baseline. Clinically driven revascularization hazard, in patients receiving 2 doses of 300×106 cells, was reduced by 49% at week 65, though not statistically significant compared to placebo. Intramuscular administration of PLX-PAD cells was concluded safe and well tolerated.
Conclusions: Following these results, a phase III clinical study will evaluate the effect on amputation free survival of two administrations of 300×106 PLX-PAD cells originating from different donors in patients with critical limb ischemia unsuitable for revascularization. $graphic_{51C1868E-E68A-4EDF-