Pluristem Announces Encouraging Six-Month Follow-Up Results of Its Phase I Critical Limb Ischemia Clinical Trials
HAIFA, Israel, Apr 13, 2011
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), today announced that following completion of three and six month clinical follow-up, data from its two open-label, dose-escalation, Phase I clinical trials conducted in the US and Germany suggests that Pluristem's 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). Among the 27 patients treated with PLX-PAD, only one 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%.
Full results of Pluristem's clinical trials are expected to be published in a peer-reviewed journal within the next few months.
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 unreconstructable disease, approximately 40% will require major amputation within 6 months of initial diagnosis.
"The results of these trials provide an indication that our PLX-PAD product, intended for the treatment of various stages of PAD, could help millions of patients around the world," said Zami Aberman, Chairman and CEO of Pluristem. "We look forward to conducting the next phase of testing PLX-PAD in the treatment of Intermittent Claudication (IC) and CLI and taking the next steps towards moving this cell therapy product candidate towards future approval as therapy for PAD patients." |
