Prostate Cancer Prostate cancer is the second most common type of cancer in men in the United States, after skin cancer, and the third leading cause of cancer death in men. An estimated 218,890 new cases will occur in the United States in 2007, and about 1 in 35 men will die of the disease, according to the American Cancer Society. In Europe, there are approximately 225,000 prostate cancer cases and 83,000 deaths annually, according to the International Agency for Research on Cancer's GLOBOCAN 2002 database. Prostate tumors that have stopped responding to hormone therapy or are growing despite the use of active hormone treatment strategies are characterized as hormone-refractory. The next option to consider for these patients is chemotherapy. Docetaxel (Taxotere®), in combination with prednisone, was approved by the FDA in 2004 for the treatment of patients with hormone-refractory metastatic prostate cancer. The majority (more than 80 percent) of newly diagnosed stage IV patients who fail hormone therapy are currently treated with docetaxel with prednisone. Poniard's Phase 1 trial of picoplatin in chemotherapy-naïve hormone-refractory prostate cancer (HRPC) patients explored increasing doses of picoplatin in combination with 60 or 75 mg/m2 docetaxel administered every three weeks, with prednisone 10 mg daily. Previous safety data were confirmed, showing that the picoplatin and docetaxel combination was well tolerated with no evidence of the neurotoxicity or kidney toxicity observed with other platinum-based chemotherapies in use for other solid tumors. Myelosuppression was the dose limiting toxicity. A Phase 2 trial of intravenous picoplatin in combination with the taxane docetaxel (Taxotere®) and prednisone in patients with metastatic HRPC is currently under way. This proof-of-concept trial of approximately 30 patients is designed to demonstrate that picoplatin improves efficacy when combined with the recommended dose of docetaxel and prednisone in the first-line setting. This single-arm trial is examining 120 mg/m2 picoplatin in combination with 75 mg/m2 docetaxel administered once every three weeks with 10 mg prednisone daily. In addition to safety, the trial is evaluating overall survival, prostate specific antigen (PSA) response, tumor response, time to progression and progression free survival. The Company enrolled this trial at the end of 2007. The Company expects to present clinical data from the Phase 1 and Phase 2 HRPC trials at scientific meetings throughout 2008.