CARDIOVASCULAR DISEASE
Our core DNA delivery technology may allow the targeted delivery of certain proteins with potential therapeutic value in the emerging field of angiogenesis, the goal of which is inducing the growth of new blood vessels to replace those blocked by disease. Angiogenesis has been shown to occur by the exogenous administration of angiogenic growth factors. We believe that the localized and sustained expression of these growth factors from plasmids will be both safe and effective. Although several attempts by others to intermittently deliver recombinant specific angiogenic growth factors directly have been unsuccessful, we believe our approach to deliver locally DNA segments that encode the desired growth factors is promising. Local delivery of angiogenic growth factor genes using our core technology is in advanced human trials, ranking these efforts among the most advanced DNA-based therapeutic protein applications.
Sanofi-aventis and AnGes MG have applied our technologies to the local and sustained delivery of genes that encode angiogenic growth factors which promote the growth of blood vessels. Patients suffering from peripheral vascular disease may avoid amputation of limbs succumbing to restricted blood flow.
AnGes stopped its Phase 3 trial in June 2007 after an interim analysis on the first 41 patients showed that the primary efficacy endpoint in the trial had been achieved with statistical significance and that there were no major safety concerns related to treatment. On the basis of these data, AnGes is preparing to file for marketing approval in Japan.
Sanofi-aventis started a 500-patient Phase 3 trial in late 2007 and expects to file for marketing approval in 2010.