Prostate Cancer
More than 2 million American men are currently living with prostate cancer, and it is the most common cancer, other than skin cancers, among men in the U.S. In 2009, an estimated 192,280 new cases of prostate cancer are expected to be diagnosed. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer, with an estimated 27,360 deaths in 2009.1 All patients with metastatic prostate cancer eventually become refractory to hormone treatment. To date, a docetaxel-containing regimen is the only treatment regimen proven to prolong the lives of patients with castration-resistant prostate cancer (CRPC).
Poniard presented final data from the Company's Phase 2 clinical trial of picoplatin in 32 men with metastatic CRPC during the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium. These data indicated that picoplatin, when added to the recommended first-line therapy of docetaxel and prednisone for CRPC, is active as demonstrated by overall survival (21.4 months) in 29 evaluable patients, progression-free survival (PFS) (7.4 months), and prostate specific antigen (PSA) response rate (78 percent). In contrast, data from published literature demonstrate an overall survival benefit of 18.9 months, and a PSA response of 45 percent for patients who received recommended doses of docetaxel and prednisone alone. The Phase 2 trial evaluated the efficacy and safety of intravenous picoplatin (120 mg/meter squared) administered every three weeks in combination with full doses of docetaxel (75 mg/meter squared) with daily prednisone (5 mg) as a first-line treatment in chemotherapy näive patients with metastatic CRPC. These results also showed that picoplatin can be safely administered with full doses of docetaxel and prednisone, without neurotoxicity being observed in these patients.
The Company will leverage insights gained from Phase 2 trial to develop a registration strategy for prostate cancer in collaboration with key opinion leaders and the FDA.
1American Cancer Society, Cancer Facts and Figures 2009
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