August 11, 2014
Taxus Cardium Pharmaceuticals Group
reported results of a phase III study of Generx Ad5FGF-4 for myocardial ischemia due to coronary artery disease. The 100 subject, randomized, multi-center, controlled study has two parallel arms (Generx and control) being conducted at medical centers in the Russian Federation. At eight weeks, Generx treatment resulted in a 24% improvement in reversible perfusion defect size (RPDS), a statistically significant response compared to the control group (p=0.01, n=11). The observed improvement in RPDS with Generx in the ASPIRE trial is consistent with RPDS improvement previously reported in the Generx AGENT phase II clinical study (n=52). Furthermore, the improvements in RPDS reported in both the ASPIRE and AGENT clinical studies are similar in magnitude to large vessel revascularization procedures, either bypass surgery or angioplasty (PCI), involving the right coronary artery (RCA), the left anterior descending artery (LAD) and the left circumflex artery (LCx), as reported in patients undergoing these procedures.
April 9, 2012
Stemedica reported results from a phase II trial evaluating ischemic tolerant mesenchymal stem cells (itMSC) following myocardial infarction (heart attack). The trial enrolled 45 subjects who had experienced an acute myocardial infarct. The subjects underwent reperfusion by stent and were divided into a treatment and a control group. The treatment group received intravenous infusion of itMSCs on day seven; the control group received normal saline. The goal was to demonstrate an improvement in the pumping function of the left ventricle. At the end of three months, those in the treatment group experienced an 11 point improvement in the ejection fraction of the left ventricle compared to the control group. This level of improvement restored the treatment group's ejection fraction to normal levels. In comparison, the control group showed a level of improvement expected with standard of care; however, the ejection fraction remained below normal. The treatment group also had statistically significant improvements in two blood markers of inflammation; levels of C-reactive protein and BNP, as well as improvement in quality of life indicators. In addition, Magnetic Resonance Imaging performed day six and day 30 showed significant decreases in lesion size.
September 17, 2007
CV Therapeutics released positive results from a phase III trial of Ranexa for the treatment of Non-ST Elevation Acute Coronary Syndromes. This international, double-blind, randomized, placebo-controlled, parallel-group study was dubbed MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes). The trial enrolled 6,560 subjects who received intravenous Ranexa or placebo within 48 hours of the onset of angina due to ACS. This was followed by an out-patient treatment period with Ranexa extended-release tablets or placebo. All subjects received concurrent standard of care therapy. Results showed that the subjects receiving Ranexa had a 37% reduction in their relative risk of ventricular tachycardia lasting eight beats or more (p<0.001). In addition, there were fewer episodes of sudden cardiac death observed in the Ranexa group, with 56 deaths than in the placebo group, with 65 deaths. Based on positive phase III results, CV Therapeutics plans to file a sNDA with the FDA in the fall of 2007.