PHARMACODYNAMIC STUDY OF ORAL MIRTOSELECT IN PATIENTS WITH SUSPECTED COLORECTAL DISEASE

Primary objectives: The main primary objective is to assess levels of anthocyanins and their metabolites achieved in biomatrices from patients following a seven-day course of oral Mirtoselect. Specifically, the following detailed aims are to be achieved:
• To measure the levels of anthocyanins in normal and malignant colorectal tissues. • To compare concentrations of anthocyanins achieved in tissues after three different oral dose levels of Mirtoselect.• To assess the levels of anthocyanins and their metabolites in peripheral venous circulation, urine and stool.
Primary endpoints: Levels of anthocyanins and their metabolites achieved in colorectal tissue, urine and the perhipheral venous cirulation.
Levels of molecular biomarkers (including levels of oxidative DNA adduct M1dG, ii. levels of inducible COX-2, iii. levels of phosphorylated EGFR, iv. indicators of proliferation (e.g. Ki67), angiogenesis (e.g. CD 34) and apoptosis (e.g. caspase 3)).