December 17, 2010 – Data published in Circulation: Cardiovascular Interventions showed that a protein used with coronary stents significantly reduced two key biomarkers of cardiac damage in patients with acute coronary syndrome (ACS). VT-111, a protein produced by the myxoma virus, was used by Viron Therapeutics.
The protein is usually used by the virus to lower its host’s inflammatory response to infection.
Cardiovascular stents have dramatically improved the outcomes for patients with occlusive coronary artery disease, but studies show that the procedure can cause peri-procedural myocardial injury (PMI). In fact, a review in the European Heart Journal showed that 30 percent of patients sustain an injury to the heart tissue that’s caused by the procedure.
The company’s phase 2a trial showed that 2 key biomarkers for heart damage, CK-MB and Troponin I, are significantly reduced by the VT-111 protein.
Numerous studies have shown that a rise in CK-MB and Troponin I in the first 24 to 48 hours after placement of a stent is evidence of heart tissue damage. A therapy to reduce PMI would need to impact these biomarkers in that critical first 24 hours.
VT-111 also showed a strong trend towards reducing major adverse cardiac events (MACE) such as myocardial infarction, revascularization, coronary artery bypass graft (CABG) or death. In the study, the higher dose group had no MACE events at six months, compared to the placebo group, which had a 17 percent MACE rate.
"Reductions in these cardiac enzymes are very encouraging given the strong correlation between a rise early after the procedure and the probability that those patients will experience a subsequent clinical event," said Dr. Carl Pepine, past president of the American College of Cardiology. "These data are even more encouraging when you note that the high dose group saw no MACE compared to the 17 percent MACE rate seen in the placebo arm of the study. I am very interested to see a larger study of VT-111 in this patient population. It may also be possible for VT-111 to have an even greater impact if delivered in doses above the top dose of 15 micrograms per kilogram (µg/kg) tested in this trial."
The company plans to continue further clinical testing in 2011.
For more information: www.vironinc.com