Prostate cancer health disparities studies have shown that African-American (AA) men are at higher risk for developing prostate cancer, as well as at higher risk of cancer specific death rates, as compared to Caucasian American (CA) men. Causes of disparities have been attributed to socioeconomic differences, environmental exposures and biological factors; however, the lack of relevant in vitro and in vivo models has limited biological and mechanistic studies. In the Phase I SBIR contract effort, we completed feasibility studies of establishing annotated, same donor cancer and normal prostate epithelial cell lines from an AA patient. We developed standard operating procedures and reagents for establishing cancer and normal prostate epithelial cell lines using conditional reprogramming cell (CRC) technology. In this Phase II SBIR contract application, we propose to establish prostate epithelial cancer cell lines from 50 AA patients to serve as the product for commercialization for use in health disparities research. Furthermore, a niche marketing assessment and negotiations with Propagenix, Inc. to license the CRC intellectual property supports the development of a commercialization plan for AA cell distribution and reagent marketing. Scope Prostate cancer and normal epithelial cell lines will be established from 50 African- American patients presenting with prostate cancer for use in health disparities research. This Phase II SBIR effort will complete tasks to meet four objectives to establish 50 prostate cancer cell lines for commercialization for health disparities research. Objective 1 is to establish 25 prostate paired epithelial cancer and normal cell lines from AA prostate surgical specimens and 25 prostate epithelial cancer cell lines from targeted needle biopsies (product#1). In objective 2, paired tumor/normal micro-arrays will be designed and manufactured (product#2). In objective 3, proprietary, supplemented conditioned medium will be manufactured for growing AA prostate cancer cells (product #3). In objective 4, a plan will be advanced to commercialize and market the AA derived prostate cancer cells and related products for health disparities research.
