Picoplatin for the Treatment of Small Cell Lung Cancer | ||
Complete discussions with the U.S. Food and Drug Administration (FDA) regarding a regulatory path forward for picoplatin in small cell lung cancer (SCLC). | ||
The Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial enrolled 401 patients and evaluated intravenous picoplatin in SCLC patients who failed or relapsed following first-line platinum therapy within six months following initial treatment with a platinum-based therapy. While the data analysis showed that the study did not meet the primary endpoint of overall survival, the data suggest a potential trend toward a survival advantage in SCLC patients treated with picoplatin and best supportive care compared to best supportive care alone. The intent-to-treat analysis was based on 321 patient deaths and showed a hazard ratio of 0.82 and a p value of 0.089. | ||
Submit SPEAR efficacy and safety data for potential presentation at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting taking place June 4-8, 2010 in Chicago. | ||
Picoplatin for the Treatment of Colorectal Cancer | ||
Present additional data from the Company's Phase 2 trial evaluating picoplatin as a neuropathy-sparing agent compared to oxaliplatin in the first-line treatment of patients with metastatic colorectal cancer (CRC) on Sunday, January 24, 2010 at the ASCO 2010 Gastrointestinal Cancers Symposium in Orlando, Fla. This randomized, controlled trial is being conducted with 101 metastatic CRC patients who have not received prior chemotherapy and is comparing the safety, including the incidence and severity of neuropathy, and efficacy, measured by overall survival, progression-free survival and disease control, of intravenous picoplatin in combination with 5-fluorouracil and leucovorin (the FOLPI regimen) to oxaliplatin given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen. | ||
Data to date have shown a statistically significant reduction in neurotoxicities with the use of picoplatin in the FOLPI regimen compared with the use of oxaliplatin in the FOLFOX regimen (p<0.0019). In addition, picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity as assessed by progression-free survival (PFS) and disease control. | ||
Picoplatin for the Treatment of Prostate Cancer | ||
Present additional data from the Company's Phase 2 trial of picoplatin in patients with metastatic castration-resistant prostate cancer (CRPC) at the ASCO 2010 Genitourinary Cancers Symposium on March 5, 2010 in San Francisco. This study is evaluating the efficacy and safety of picoplatin administered every three weeks in combination with full-dose docetaxel and daily prednisone as a first-line treatment in patients with metastatic CRPC who have not received prior chemotherapy. Prostate-specific antigen (PSA) response (defined as a PSA reduction of at least 50 percent from baseline for 4 weeks) is the primary endpoint of the study. Secondary endpoints include safety, disease control, time to progression and overall survival. | ||
Data to date indicate that picoplatin, in combination with docetaxel and prednisone, shows promising efficacy and is well tolerated as first-line therapy for metastatic CRPC. Efficacy is assessed by several endpoints, including reductions in PSA levels, disease control, and PFS. Safety data to date indicate that picoplatin can be administered every three weeks for up to 10 cycles concurrently with full doses of docetaxel and prednisone which is the current standard first-line treatment for metastatic CRPC. In addition, no neurotoxicity has been observed in this study to date. | ||
