MULTIFUNCTIONAL DRUG-DELIVERY STENT WITH NANOPOROUS COAT

The overall long-term objective of this proposal is to develop a loco-regional multi-functional theranostic delivery system (MTDS) to treat lung cancer in patients with focal disease, as an adjunct to systemic therapy. The proposed MTDS, releases a clinically proven, cocktail of cancer chemotherapeutic drugs and a fluorescent dye. The cocktail is loaded on a tracheo-bronchial nitinol stent with a nano-porous, radio-opaque, Tantalum coat. It has multiple modes of action. The physical platform in addition to being radio-opaque, props open any obstruction, the combination drugs treat the cancer and the fluorescent dye lights up the tumor to allowing visualization and monitoring of the treatment. The MTDS is predicted to provide rapid relief of breathlessness symptoms in patients with airway obstruction, improve quality of life, reduce the chances of re-obstruction due to tumor re-growth and associated medical costs and, most importantly, may prolong survival. The MTDS is a platform technology and has the potential to treat other cancers such esophageal, colon, bile duct and other cancers. The specific aims of this proposal include: Demonstrating the feasibility of developing prototype MTDS with slow, and fast drug and dye release profile, developing test methods to evaluate performance, and testing the effectiveness of the lead prototype MTDS in a mouse tumor model. The research methods are expected to result in (a) identifying the technological limitations and conditions that provide maximum drug and dye loading capacity with desired release profiles (b) identifying the sensitivity and accuracy of the test methods (c) identifying a therapeutically effective dose window in the mouse tumor model (d) Projecting product profile for clinical testing.