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Cardium Announces Cedars-Sinai Heart Institute as the SPECT Imaging Core Lab for the Recently Announced Generx® Phase 3 Clinical Registration Study in the Russian Federation
Date:6/22/2011

ta analysis of nuclear myocardial perfusion studies.  The Core Laboratory is led by Daniel S. Berman, M.D., who has been the head of Nuclear Cardiology at Cedars-Sinai Medical Center for over 30 years, and is the Associate Director for Cardiac Imaging at the Cedars-Sinai Heart Institute.  Dr. Berman is considered a leader in the field of SPECT myocardial perfusion imaging and has authored over 300 original peer-reviewed manuscripts dealing with non-invasive cardiac imaging.

SPECT imaging data from the ASPIRE clinical trial sites in Russia will be electronically sent by study investigators to the Cedars-Sinai Core Laboratory where the imaging data will be compiled and interpreted for Cardium, the US-based sponsor of the ASPIRE study.  Cedars-Sinai Core Laboratory was previously responsible for the data management, evaluation and interpretation of a successful Generx Phase 2 clinical study that also used SPECT myocardial perfusion imaging as the endpoint measure.  Positive results from this Phase 2 clinical study (Grines et al., J Am Coll Cardiol 2003; 42:1339-47) showed that Generx improved myocardial blood flow in the ischemic region of the hearts of patients following a single intracoronary infusion, as measured by SPECT imaging.  As noted in the publication, the mean change observed in Generx-treated patients was a 4.2% absolute reduction (which represents a 20% relative reduction) in the reversible perfusion defect size from baseline at eight weeks (p<0.001), while the placebo group showed only a 1.6% absolute reduction from baseline (not statistically significant) at eight weeks following treatment.  The observed treatment effect for patients receiving Generx was similar in magnitude to that reported in the literature for patients undergoing angioplasty/stent or revascularization procedures with reversible perfusion defects of comparable size at one year following these procedures.

Generx is a disease-modifying rege
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SOURCE Cardium Therapeutics
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