Cardium Therapeutics has signed an agreement with bioRASI to evaluate the efficacy and safety of Generx (Ad5FGF-4) in a late-stage clinical study.
The two companies will also work together to commercialise the drug in international markets.
Generx is a DNA-based angiogenic growth factor therapeutic product candidate, which is expected to be used as a treatment for advanced coronary artery disease.
The Generx clinical study is expected to assess the drug using adenosine SPECT imaging of myocardial blood flow in patients with stable angina pectoris.
The primary endpoint of the study will be the change in reversible perfusion defect size, as measured by adenosine SPECT imaging.
A Phase IIa clinical study showed that Generx improved myocardial blood flow in the ischemic region of the human heart.
The study is expected to begin in the second half of 2010.