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Cardium Therapeutics' (NYSE MKT: CXM) Generx® product candidate (alferminogene tadenovec, Ad5FGF-4) is a DNA-based angiogenic growth factor therapeutic being developed for the potential treatment of patients with advanced coronary artery disease. Generx is designed to stimulate the growth of supplemental collateral blood vessels in the heart in order to enhance myocardial blood flow in patients who have insufficient blood flow due to atherosclerotic plaque restricting flow in the coronary arteries that supply the heart. 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.
Generx is designed as a disease-modifying regenerative medicine therapeutic that can elicit structural and physiologic changes in the heart (the growth of new collateral blood vessels) following a one-time intracoronary administration from a standard cardiac infusion catheter. In contrast, traditional drug therapies such as nitrates and beta blockers provide transient symptomatic relief of anginal chest pain without changing the underlying disease. In the United States, anti-anginal drugs have traditionally been registered by the FDA based on improvements in exercise treadmill tolerance testing (ETT), which can confirm short-term symptomatic relief of angina. Based on the disease-modifying nature of Generx, Cardium believes that a more objective and appropriate measure to assess the effectiveness of angiogenic therapy is cardiac perfusion, the actual blood flow in the heart under stress using SPECT imaging (single photon emission computed tomography) or another advanced imaging technique. Cardiac perfusion directly shows and quantifies improvements in the underlying physiologic condition, i.e. insufficient blood flow under stress. Generx is currently being developed for international markets outside United States as a treatment alternative for patients who may not have access to or may not be candidates for costly and invasive surgical revascularization procedures, such as coronary artery bypass surgery and angioplasty/stents.
Learn more at: http://cardiumthx.com/generx.html