Tokai Pharmaceuticals is focused on developing novel, proprietary therapies for prostate cancer and other hormonally-driven diseases. The company has initiated a pivotal clinical trial of its lead drug candidate, galeterone, in patients with metastatic castration resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC. This trial is the first precision medicine-based pivotal clinical trial in prostate cancer, and top-line data from the study are expected by the end of 2016.