Cardium Therapeutics has begun the ASPIRE Phase 3 registration study to assess the therapeutic effects of Cardium's Generx (Ad5FGF-4) in patients with myocardial ischemia.
Generx is a disease-modifying regenerative medicine biologic that is being developed to provide a one-time, non-surgical option to improve blood flow to the heart muscle in myocardial ischemia patients.
The ASPIRE study is a 100-patient, randomised, controlled, multi-centre trial designed to assess the safety and effectiveness of Generx, a DNA-based angiogenic product candidate in patients with myocardial ischemia due to coronary artery disease.
In the trial, the primary efficacy endpoint of the study will be the improvement in reversible perfusion defect size as measured by Single-Photon Emission Computed Tomography (SPECT) myocardial perfusion imaging, both at rest and under cardiovascular stress.
The Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory, US, will serve as the central core lab for the ASPIRE study and will be responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centres participating in the study.
Cardium chairman and chief executive officer Christopher Reinhard said the ASPIRE trial is the fifth clinical study under Generx's clinical development programme that when completed will have enrolled more than 750 patients at over 100 medical centres throughout the US, Canada, South America, Western Europe and Russia.
"With positive safety and efficacy data from this single registration study, a Generx clinical dossier would become eligible for submission for marketing and sales in the Russian Federation, and would also be expected to support 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," Reinhard added.
The ASPIRE study will also be used as part of efforts to optimise and broaden commercial development pathways in other industrialised countries such as Brazil, India, Europe and the US.
In Russia, Generx will be sold under the therapeutic drug trade name, Cardionovo, assigned by The Russian Health Authority.