This Small Business Innovation Research (SBIR) Phase I project will study the preparation and characterization of polymer based biodegradable nanoparticles of novel inhibitors of cell proliferation. The development of polymer-based biodegradable nanoparticles is guided by the desire to improve overall survival and quality of life by increasing the bioavailability of drug to the site of disease, containing delivery to the cancerous tissues, increasing drug solubility, and minimizing systemic side effects. We have recently discovered novel anti-cell proliferative compounds with specific and unique properties that make them an ideal treatment for solid tumors. The main aim of this study is preparation and characterization of nanoparticle formulations of our compounds. The compounds studied in this project have a high chance of success during clinical development because of the drugs are administered locally, which has very little change of producing toxicity, but also the molecular targets of the compound are proven to be safe therapeutic targets. Development of such novel formulations will allow sustained delivery of novel inhibitors of cell proliferation in the tumor site. The broader impact/commercial potential of this project: Development of novel therapeutics that could be delivered locally into tumor site is critically needed for several types of human malignancies. Successful development of nanoparticle formulations of the compounds studies in this project will, if successful, reduce healthcare costs by reducing the cost of cancer therapy and by improving the survival and quality of life for many patients under cancer chemotherapy. The nanoparticle formulations developed under the proposed studies could replace several combination chemotherapy regimens that have numerous side effects in addition to being very expensive
