Phase III data shows efficacy of Generx in Myocardial Ischemia- Taxus Cardium Pharma

Cardium Pharmaceuticals ( now Taxus Cardium Pharma Group) reports a pre-specified interim analysis from its international ASPIRE Phase III registration clinical study of Generx (Ad5FGF-4) angiogenic gene therapy product candidate for patients with Myocardial Ischemia due to Coronary Artery Disease. Data shows a positive safety and statistically significant efficacy from a randomized, multi-center, controlled study's primary registration endpoint of improvement in cardiac perfusion (blood flow) with Generx compared to the control group. Myocardial perfusion was measured by single-photon emission computed tomography (SPECT). Patients were randomized to receive Generx or standard treatment. Eight weeks following administration, the group of patients who received Generx were found to have significant improvements in myocardial blood flow under stress, as compared to the control group � and the degree of improvement in Generx patients was of a magnitude that is similar to that observed following coronary interventions such as bypass surgery or angioplasty and stenting. At eight weeks, Generx treatment resulted in a 24% improvement in reversible perfusion defect size , a statistically significant response compared to the control group.

The ASPIRE study's interim analysis shows that the Generx product candidate, together with Cardium's new catheter-based delivery protocol, appears to be safe and well tolerated. In addition, statistically significant improvement in myocardial perfusion was identified by the efficacy endpoint of SPECT imaging. Cardium has also conducted a pooled analysis of the SPECT results. This additional data analysis of the interim ASPIRE data with the AGENT Phase II study data shows that patients treated with Generx have a 25% improvement in RPDS that is also statistically significant compared to the pooled control groups. Data was presented at the 2014 BIO International Convention.