Cardium is expecting to initiate Generx clinical study in the second half of this year. The trial is expected to be a randomised, controlled, parallel-group, multicenter study to evaluate the safety and efficacy of Generx using adenosine Spect imaging of myocardial blood flow in patients with stable angina pectoris.
Cardium believes that Generx could potentially be developed as a cost effective front-line therapy for patients with coronary artery disease in the large markets of newly-industrialising countries who often do not have access to costly advanced care procedures such as coronary angioplasty and stenting, or cardiac bypass surgery.
Christopher Reinhard, chairman and CEO of Cardium, said: “Based on data indicating that Generx appears to safe and has the potential to substantially increase coronary blood flow in the context of heart disease, together with an independent 10-year study that underscored the significance of coronary circulation for long-term cardiac health, we believe that our Generx product candidate could be developed as a front-line therapy for coronary artery disease from a more global perspective.
“Additional data gained from our planned clinical study should also help support an expanded US registration dossier by providing additional safety data and potentially alternative efficacy measures. The more objective Spect imaging endpoint is designed to directly assess the ability of the heart to increase myocardial blood flow under conditions such as stress and is considered to be an important indicator of cardiac function and the ability of a patient’s heart to effectively handle routine exercise and daily activities, which can have a dramatic impact on a patient’s health and quality of life.”