Capstone Therapeutics Announces Pre-Clinical Results With AZX100 in Radiation and Bleomycin Models of Pulmonary Fibrosis; Pulmonary Anti-Fibrotic Effect Demonstrated

Capstone Therapeutics CAPS today announced results from a pre-clinical study of AZX100 in a rodent model of radiation-induced pulmonary fibrosis. Using the TUNEL assay – an established method for detecting DNA fragments that are the hallmark of "programmed cell death" known as "apoptosis" – a significant decrease in apoptosis among all cell types was demonstrated with AZX100 treatment for 28 days compared to untreated lung (p = 0.00058). Importantly, the TUNEL assay also showed with AZX100 treatment a significant decrease in apoptotic epithelial cells (p = 0.003). This effect translated to a greater than 70% decrease in apoptotic epithelial cell count with AZX100 compared to the untreated cohort. Preservation of normal epithelial cells is required for proper lung function. Using the hydroxyproline assay for collagen assessment - a well-characterized and accepted method for biochemical evaluation of fibrosis - a trend toward decreased hydroxyproline content was observed after AZX100 treatment for 28 days (p = 0.067). These data provide additional pre-clinical evidence supporting an anti-fibrotic effect of aerosolized AZX100 in lung tissue. Earlier studies in the bleomycin-induced model of pulmonary fibrosis showed that AZX100 treatment significantly reduced soluble and tissue collagen (p = <0.05) and inflammation (shown via significant decreases in TNF-alpha and TGF-beta, p = <0.05) at a 1 mg/kg single daily dose for 18 days. Treatment with AZX100 was also shown to modulate several pulmonary metabolic pathways‚ including circadian rhythm and cytoskeletal remodeling. (Data from these studies were presented at the American Thoracic Society International Conference, May-2011- Denver, CO.)