Pluristem (PSTI) 6 Month Follow-Up Results of PI CLI Clinical Trials
PSTI completed 3 and 6 month clinical follow-up data from its 2 open-label, dose-escalation, PI clinical trials conducted in the US and Germany.
Among the 27 patients treated with PLX-PAD, only 1 amputation was recorded, representing a 3.7% amputation rate. This represents a 75% reduction in amputation rate compared to historical data, which varies from 20-40%.
- According to Hirsch et al., ACC/AHA Practice Guidelines, chronic CLI is associated with a 1 year mortality rate greater than 20%. Nearly half of the cases will require revascularization for limb salvage and among those who have un-reconstructable disease, approximately 40% will require major amputation within 6 months of initial diagnosis.
The Bottom Line: The data suggests that placenta-derived cell therapy, PLX-PAD, is safe, improves quality of life, and is potentially effective in treating patients and reducing amputations in those suffering from Critical Limb Ischemia (CLI), the end-stage of Peripheral Artery Disease (PAD). PSTI is initiating the next phase of testing PLX-PAD in the treatment of Intermittent Claudication (IC) and CLI. PSTI climbed (4/13/11) to the highest level in more than 2 months, up $0.25 (8.47%) to $3.20 in pre-markets. The shares advanced as much as 7.5% to 11.19 shekels, the highest since 2/7, and traded 4.9% higher at 10.92 shekels in Tel Aviv.
