The recruitment for Thrombologic's first clinical safety pilot study was completed in May 2011 and data analysis has now been completed.
The primary end-point was reached as no adverse safety signal was found with regards to bleeding when compared in the placebo and active groups, in patients undergoing a primary PCI (percutaneous coronary intervention) following administration of our combination product.
In addition to the safety data an endothelial marker showed a statistically significant difference at 48 h(p=0.0063) between the active and the placebo groups which could indicated that the active treatment induced a long-term protection of the endothelium that persisted even after ceasing the treatment (at 24h).
Thrombologic is moving forward and will conduct a small phase IIa study in critically ill patients, this study is expected to start in H2 2011.