GPC Biotech AG (GPCB) said Tuesday that it has initiated a mid-stage trial to assess satraplatin in combination with the steroid, prednisone, in patients with metastatic hormone-refractory prostate cancer or HRPC, and previously treated with doxetaxal or Taxotere. The study seeks to determine if the presence of certain gene impacts patient outcome.
The Phase 2 trial is a single-arm study, in which the company plans to enroll 66 patients with metastatic HRPC, previously having undergone docetaxel therapy with no more than one other previous cytotoxic chemotherapy regimen.
The primary objective of the trial is to determine if the presence of certain variants of the gene, ERCC1, affects progression-free survival in this patient population. ERCC1 is involved in DNA damage repair. Similar to other platinum agents, Satraplatin has shown target the DNA in tumor cells.
The study is being sponsored by the U.S. National Cancer Institute.
Satraplatin is an oral compound that clinical trial patients are able to take from home. GPC Biotech is expecting approval from the European regulators to market satraplatin in combination with prednisone for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed by the second half of 2008.
GPCB is currently trading at $4.14, up 28 cents or 7.25%.
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