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Cardium Reports on Presentation at American Heart Association Meeting Relating to Gene Delivery to the Heart and Generx Clinical Development

lferminogene tadenovec, Ad5FGF-4) is a DNA-based angiogenic growth factor therapeutic product candidate representing a new class of cardiovascular biologics as a treatment for patients with advanced coronary artery disease.  Generx is designed to stimulate and promote the growth of collateral vessels to enhance myocardial blood flow (perfusion) following a one-time intracoronary administration from a standard cardiac infusion catheter in patients who have insufficient blood flow due to atherosclerotic plaque build-up in the coronary arteries.  Generx has progressed through four randomized, placebo controlled clinical studies at over 100 medical centers in the United States and Western Europe that have enrolled over 650 patients.

In June 2010, Cardium announced that it had entered into a Master Services Agreement with bioRASI, an international contract research organization, to assist in the conduct of a late-stage clinical study (ASPIRE) designed to support regulatory approval and commercialization activities for Generx in Russia and affiliated jurisdictions, as well as in other newly industrializing markets.  The Generx clinical study will be conducted at three leading medical centers in Moscow and will be a randomized, controlled, parallel-group, multi-center study to evaluate the safety and efficacy of Generx using SPECT imaging of myocardial blood flow in patients with stable angina pectoris.  The primary endpoint will be the change in reversible perfusion defect size as measured by SPECT imaging, which is directly analogous to that successfully used in a Phase 2a clinical study of Generx in the United States.  

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 men and women following a single intracoronary infusion as measured by the objective efficacy endpoint o

SOURCE Cardium Therapeutics
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