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.
February 13, 2012
Merck released results from a clinical trial of vorapaxar, under development for the prevention of thrombosis and the reduction of cardiovascular events. TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) was a secondary prevention study in 26,449 subjects with a heart attack, an ischemic stroke, or documented peripheral vascular disease. The subjects received vorapaxar plus standard of care or standard of care alone. The addition of vorapaxar to standard of care significantly reduced the risk of the primary endpoint of the composite of cardiovascular death, heart attack, stroke or urgent coronary revascularization compared to standard of care. There was a significant increase in bleeding, including intracranial hemorrhage, among subjects taking vorapaxar in addition to standard of care.
December 8, 2003
Genzyme reported positive results from two phase I trials investigating an HIF-1alpha gene therapy for the treatment of critical limb ischemia. Results showed that Ad2/HIF-1alpha/VP16 was safe, with no treatment-related serious adverse events reported. The randomized, double-blind, placebo controlled study trial enrolled 28 subjects with advanced critical limb ischemia. Preliminary results were also reported from a companion open-label dose escalation trial. Three placebo subjects from the main trial received Ad2/HIF-1alpha/VP16, and 10 new subjects received Ad2/HIF-1alpha/VP16. Data showed that complete ulcer healing was observed in three of the five treated subjects, assessed at one year. Results were reported at the American Heart Association's annual meeting in Orlando.
September 22, 2003
Boston Scientific reported positive results from a medical device trial investigating Taxus IV, a drug eluting stent for the treatment of restenosis. Results showed a target lesion revascularization (TLR) rate of 3.0% with Taxus compared with 11.3% in the control group. Data demonstrated an in-segment binary restenosis rate, defined as 50% or greater vessel re-occlusion, of 7.9% with Taxus compared with 26.6% in the control group. The randomized, double blind pivotal trial enrolled 1,326 subjects and was designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent system in reducing. Results were reported at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C.