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Cardium Therapeutics, Inc. (CXM) Wins IP Protection for Cardiovascular Gene Therapy

Cardium Therapeutics, an asset-based health sciences and regenerative medicine company, today announced it was on the winning side of a patent decision made in Europe. This decision resolved a long-standing competition between Cardium and its licensor the University of California, and Boston Scientific (NYSE: 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. Cardium’s Generx® gene therapy candidate, which employs these key methods, is currently in late-stage clinical studies.

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.

The competing patent applications licensed by Boston Scientific Corporation had been the subject of opposition proceedings in Europe and interference proceedings in the United States, both of which were ultimately resolved in Cardium’s favor. After further examining Cardium’s case, the European Patent Office approved Cardium’s patent application for grant in Europe. Three corresponding U.S. Patents that had been challenged by Boston Scientific Corporation have been affirmed in the favor of Cardium.

Cardium has additional patents and patent applications involving its methods of cardiovascular gene therapy in the U.S., Europe, Russia, and in other parts of the world, and the company recently filed new patent applications involving 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. 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,” stated Dr. Tyler M. 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 (NASDAQ: 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.

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