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Phase III of the double-blind, randomized Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial has shown a 40% reduction in the risk of disease progression in patients who received satraplatin plus prednisone.
Phase III of the double-blind, randomized Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial has shown a 40% reduction in the risk of prostate cancer progression in patients who received satraplatin plus prednisone.
The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as second-line treatment in 950 patients with hormone-refractory prostate cancer. Researchers reported that the results for progression-free survival were highly statistically significant (p<.00001).
Improvement seen in progression-free survival by patients treated with satraplatin and prednisone increased over time. Median progression-free survival demonstrated a 13% improvement in those in the satraplatin cohort (11 weeks) compared with those in the placebo group (9.7 weeks). This improvement was not affected by the type of prior chemotherapy; in particular, improvement was seen equally for patients who had received prior treatment with docetaxel (Taxotere), as well as those who received other types of chemotherapy treatments.
GPC Biotech AG and Pharmion Corp., the companies sponsoring the trial, expect to have final overall survival results in the third quarter of 2007.
“Based on the positive data, we will move forward as rapidly as possible with the FDA with the goal of completing the filing for marketing approval of satraplatin in the U.S. before the end of this year,” said Bernd R. Seizinger, MD, PhD, CEO of GPC Biotech.