SBIR Phase I: Drug Eluting Stents to Treat Obstructed Tracheo-Bronchial Lumen Due to Lung Cancer

This Small Business Innovation Research (SBIR) Phase I research project will demonstrate the feasibility of developing a tracheobronchial drug eluting stent (DES) by coating a biodegradable polymeric formulation of Paclitaxel (PTX) on a stent. The stent will provide immediate palliative therapy and will also serve as a loco-regional delivery system for the polymeric PTX formulation. The proposed DES product is a multi-modal therapy to treat airway obstruction due to endobronchial, extrinsic and mixed tracheobronchial tumors. This is the first time report of a tracheo-bronchial drug eluting stent. Lung cancer is one of the major diseases causing airway obstruction and the single largest cause of cancer deaths in the United States (173,000 new cases diagnosed in 2004) with more than 160,000 people to of the disease each year. In spite of the monumental efforts in developing chemo and radiation therapies, little progress has been made towards curing lung cancer. Local tumor control with endobronchial intervention is an important adjunct to the multimodality management of advanced lung cancer. Commercially, the application is use as an adjunct treatment for cancer and, by virtue of targeting multiple processes (physical and biological/molecular); the Paclitaxel drug eluting stent (DES) has the potential of being superior to any single endobronchial intervention without the limitations of an uncoated stent. This DES product will provide rapid relief of symptoms, improved quality of life, and prolonged survival to many lung cancer patients. Even though prognosis for lung cancer patients is poor, the direct medical cost of lung cancer in the United States is over $5 billion per year. Furthermore, the United States spends more than $1 billion per year for the most common drug treatment for lung cancer that is minimally more effective than previous treatments that are 20% less costly. These market numbers show that insurance companies, Medicare, and society in general are willing to spend money to treat and manage lung cancer even if the chances of survival are low. The ability to give a person a few more months of living or a better quality of life for their last few months is priceless.