Generx DNA-Based Angiogenic Therapy Receives Clearance For Late-Stage Registration Clinical Study For Coronary Artery Disease

Cardium Therapeutics (NYSE Amex: CXM) today announced that it has received clearance from the Russian Ministry of Health and Social Development to commence a Phase 3 registration study for the Company's Generx™ (alferminogene tadenovec, Ad5FGF-4) biologic product candidate. Generx is a new and innovative DNA-based angiogenic therapy designed for the potential treatment of myocardial ischemia due to coronary artery disease. The Russian Health Authority has assigned Generx the therapeutic drug trade name of Cardionovo™ for marketing and sales in Russia. The new YouTube video "Cardium Generx Cardio-Chant" provides an overview of the Company's Generx product candidate, here.



This newly approved clinical study (ASPIRE) is a randomized, controlled, parallel group, multi-center study designed to evaluate the safety and efficacy of Cardium's Generx product candidate using SPECT imaging to measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx DNA-based angiogenic therapy. As designed, the ASPIRE clinical study is expected to enroll approximately 100 men and women with myocardial ischemia due to coronary artery disease at up to three leading medical centers in Moscow. The study's primary efficacy endpoint will be the improvement in reversible perfusion defect size as measured by SPECT imaging.



The ASPIRE study will represent the fifth clinical study under Generx's clinical development program that when completed will have enrolled more than 750 patients at over 100 medical centers throughout the U.S., Canada, South America, Western Europe and Russia. Based on the specified clearance for the Russian Health Authority, with positive safety and efficacy data from this single registration study, Cardium's Russian sponsor and development partner, Advanced Biosciences Research, an affiliate of the contract research organization bioRASI, would be in a position to consider the submission of an application for marketing and sales of Generx in the Russian Federation, and to advance forward with applications and submissions seeking approval for marketing and sales of Generx in certain other countries of the Commonwealth of Independent States, comprising former republics under the Soviet Union. The ASPIRE study could also provide additional clinical evidence regarding the safety and effectiveness of Generx that would be useful for optimizing and broadening commercial development pathways in other industrialized countries.



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 of 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 (pBuy Nizoral Without Prescription