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Cardium Announces Presentaton at The 2013 Cell & Gene Therapy Forum
Date:1/29/2013

ment in treadmill exercise time (ETT) to a more objective efficacy endpoint of reduction in reversible perfusion deficit based on SPECT myocardial perfusion imaging.  Similar to mechanical/surgical cardiac revascularization approaches, the goal of Generx treatment is to improve myocardial perfusion (blood flow).  SPECT myocardial perfusion imaging can be used to quantitatively evaluate Generx's effectiveness by measuring improved myocardial blood flow under stress, a key prognostic indicator that is associated with the regenerative process of new collateral vessel formation in and around the regions of ischemia.  While walking time during ETT has been a traditional efficacy measure of anti-anginal drugs, it is based on a subjective assessment of chest pain (angina pectoris), does not directly measure improvements in cardiac blood flow, and can be affected by other variables.  Positive results from the prior Phase 2a 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 the objective efficacy endpoint of SPECT imaging.  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.

ASPIRE Study

The ASPIRE study is a 100-patient, randomized and controlled multi-center study currently enrolling patients at up to eight leading cardiology centers in the Russian Federation.  The ASPIRE study is designed to further evaluate the safety and effectiveness of Cardium's Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S., <
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SOURCE Cardium Therapeutics
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