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Pluristem (PSTI) 6 Month Follow-Up Results of PI CLI Clinical Trials

Apr. 13, 2011 12:32 PM ET
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Long/Short Equity, Special Situations, Contrarian

Seeking Alpha Analyst Since 2009

Editor and Publisher ... Henry enters his thirteen (13) year at RegMed Investors which aggregates, curates and creates bottom-line content of regenerative medicine - stem, gene and cell therapy news providing a "vetted" selection of relevant and high-impact synthesis. He was VP - Strategic Planning and Communication at Curis (2001-2002), HQCM focusing on healthcare investments (NYSE:HQH/HQL) from (1985-2001)and founded LifeScience Economics, a healthcare research and analytics firm with offices in Boston, MA and Palo Alto, CA. Past experiences include Thermo Scientific, SWEC following 5 years at the FBI. A former military officer, Henry has been an adjunct professor at Boston University and Golden Gate University where he taught courses in venture capital, corporate finance and strategic development in the universities' graduate business schools.
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.

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