SAN DIEGO, Nov. 19, 2012 /PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today announced a winning patent decision in Europe and successful resolution of a long-standing competition between Cardium and its licensor the University of California, and Boston Scientific Corporation (BSX) and its licensor Arch Development, over rights to key methods for the application of cardiovascular gene therapy to the treatment of coronary heart disease, as is employed in Cardium's Generx gene therapy candidate currently in late-stage clinical studies. Following a decision by the European Patent Office, Cardium's patent portfolio now includes allowed and issued patents covering its gene therapy approach both in Europe and in the United States, with competing patent applications licensed and pursued by Boston Scientific having been successfully overcome in both Europe and the U.S.

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The competing patent applications licensed by Boston Scientific Corporation had been filed by Dr. Jeffrey Leiden et al., currently President & CEO of Vertex Pharmaceuticals, and had been the subject of opposition proceedings in Europe and interference proceedings in the United States, both of which were ultimately resolved in favor of Cardium. Following resolution of the opposition proceedings and further examination of Cardium's case, the European Patent Office has now approved Cardium's patent application for grant in Europe. Three corresponding U.S. Patents that had been challenged by Boston Scientific Corporation (in decisions that were appealed to the United States Court of Appeals for the Federal Circuit), have been affirmed in Cardium's favor.

Cardium has additional patents and patent applications directed to its methods of cardiovascular gene therapy in the U.S., Europe, Russia and elsewhere, and the company recently filed new patent applications directed to certain improved techniques for the treatment of heart disease that are currently the subject of a Phase 3 registration trial based in Moscow, which is designed to generate additional safety and effectiveness data for the Russian Federation and other jurisdictions. Generx (alferminogene tadenovec) is intended to stimulate the growth of collateral blood vessels to effectively bypass coronary artery atherosclerotic blockages without the need for surgical procedures or angioplasty and stents; and its safety and effectiveness have been the subject of clinical studies involving more than 650 patients in the U.S., Europe and elsewhere. Generx has been assigned the trade name Cardionovo for planned commercialization in the Russian Federation. Cardium believes that its Generx clinical database represents the largest and most complete gene therapy dossier and is directed to a major medical indication that is a leading cause of death throughout the developed world.

"The resolution of these important reviews of our gene therapy patents, and the consistent decisions in our favor including rulings by the U.S. courts of appeal, underscore the value of our patent portfolio, which we believe reflects a breakthrough approach to the treatment of coronary heart disease," said Dr.TylerM.Dylan-Hyde, Chief Business Officer and General Counsel of Cardium Therapeutics.

Recently-published findings demonstrate that Cardium's innovative technique employing transient cardiac ischemia can be used to dramatically enhance gene delivery and transfection efficiency after one-time intracoronary administration of adenovector in mammalian hearts. Two consecutive but brief periods of coronary artery occlusion combined with co-administration of nitroglycerin increased both adenovector presence (measured by PCR) and transgene expression (assessed by luciferase activity) by over two orders of magnitude (>100 fold) in the heart, as compared to prior intracoronary artery delivery methods.

The research results published in Human Gene Therapy Methods extend those findings and demonstrate that Cardium's new technique for adenovector gene delivery in the heart can be used to dramatically boost adenovector delivery. By enhancing uptake even in patients with less severe forms of disease and ischemia, it would be expected to reduce response variability and allow for the potential treatment of patients with a broader range of associated coronary artery disease. The new treatment protocols for Cardium's recently-initiated ASPIRE clinical study have been developed to use this improved knowledge about induced transient ischemia techniques to enhance the non-surgical, catheter-based delivery of Generx to the heart.

Cardium has also been actively advancing its Generx product candidate's engineering and process technology in preparation for commercialization. The Company successfully transferred a refined, improved and fully-validated manufacturing process to SAFC, the custom manufacturing and services business unit of Sigma-Aldrich Corporation (SIAL), a top global specialty chemicals and biologics supplier, located in Carlsbad, California. As a result of the rigorous technical transfer process, important process improvements were achieved enabling much higher manufacturing process yields. Generx's long-term product stability has been established at a minimum of six years making it possible to manufacture product in large, cost effective batch sizes. The dose preparation process for Generx has been simplified through the integration of a fully-validated, closed-system drug transfer process incorporating the use of PhaSeal System passive safety technology to streamline and simplify the cath-lab preparation and eliminating the need to prepare Generx in a sterile, biological safety hood. The Company has also developed a new and unique, fully-validated bio-activity release assay to measure and evaluate the pro-angiogenic potency of each newly manufactured batch of Generx.

The European Commission's recent approval of uniQure's Glybera (alipogene tiparvovec) the first gene therapy approval by a major health regulatory authority is considered to represent a significant milestone and validation for the gene therapy industry.

About Generx and the ASPIRE Study

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Cardium Announces Patent Award For Rights To Cardiovascular Gene Therapy For The Treatment Of Heart Disease

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