Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Isotechnika Pharma Inc. announces that the results of the CONFIRM1 clinical trial conducted by its medical device partner, Atrium Medical Corporation, were presented by Glenn Van Langenhove, MD, PhD (Middelheim Hospital in Antwerp, Belgium), the principal investigator, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 Scientific Symposium in Washington, DC last week. The CONFIRM1 trial was conducted to evaluate Atrium's drug eluting coronary stent coated with voclosporin.

Dr. Van Langenhove stated that the drug coated stent was safe as it had no statistical difference in safety events compared to the bare metal stent. However, the drug coated stent did not demonstrate improved efficacy in terms of angiographic late lumen loss when compared to the bare metal control stent. Additional analyses of the intravascular ultrasound (IVUS) imaging suggested that there is a potentially important interaction of the voclosporin and Atrium's proprietary coating found in patients identified with unstable lipid pools within their coronary arteries. The imaging analysis, in some of these cases, is suggestive of a resolution of the lipid pools. Additional research would be required to elucidate these observations.

This finding is important in that there are large amounts of research ongoing in this controversial yet highly important field to understand ruptured fibrous capsules, vulnerable plaque, and lipid pools. It is believed that ruptured plaque from within these coronary vessels may be a leading cause of intracoronary thrombotic episodes and the root cause of heart attacks (acute myocardial infarctions).

Source: ISOTECHNIKA PHARMA INC.