GPC Biotech Announces Phase 2 Study of Satraplatin in Metastatic Breast Cancer

GPC Biotech AG, a biopharmaceutical company, has announced the opening of a Phase 2 study of satraplatin, its lead drug candidate, in patients with metastatic breast cancer who have received no more than one prior chemotherapy treatment regimen. The study is being managed by US Oncology, a leading healthcare services network dedicated exclusively to cancer treatment and research.

This announcement highlights the ongoing efforts to develop new and effective therapies for breast cancer, a disease that is the leading cause of cancer-related death among women in Europe and the second most common cause in the US. The study aims to enroll 80 patients and is expected to provide valuable insights into the efficacy and safety of satraplatin in this patient population.

Key Takeaways:

• The Phase 2 study of satraplatin in metastatic breast cancer is an open-label, multicenter study managed by US Oncology, with 57 research sites in the US Oncology Network participating.
• The primary objective of the study is to determine the objective response rate of satraplatin in patients with metastatic breast cancer who have received no more than one prior chemotherapy treatment regimen.
• Satraplatin is an orally bioavailable platinum compound that is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment for hormone-refractory prostate cancer.
• The FDA has granted fast track designation to satraplatin for the treatment of hormone-refractory prostate cancer, and the Company has completed a Special Protocol Assessment with the FDA and received a Scientific Advice letter from the European Medicines Agency (EMEA).
• The study is notable for its potential to provide a new treatment option for patients with advanced breast cancer, a disease that is often resistant to existing therapies and has a poor prognosis.
• US Oncology has extensive experience in conducting clinical trials, having contributed to the development of 23 of the latest cancer-fighting drugs approved by the FDA for use.

Statistics:

• It is estimated that over 210,000 new cases of invasive breast cancer will be diagnosed in the US in 2005, with over 40,000 women expected to die from the disease.
• Breast cancer is the leading cause of cancer-related death among women in Europe, with an estimated 270,000 new cases diagnosed annually and 88,000 deaths.
• The 5-year relative survival rate for localized breast cancer in the US is 98%, while the figure for patients with distant metastases is 26%.

Sources:

• GPC Biotech AG press release, "GPC Biotech AG announces the start of a Phase 2 study of satraplatin in patients with metastatic breast cancer," November 2, 2005.
• US Oncology press release, "US Oncology Announces Collaboration with GPC Biotech AG to Develop Satraplatin in Metastatic Breast Cancer," November 2, 2005.
• GPC Biotech AG website, www.gpc-biotech.com.
• US Oncology website, www.usoncology.com.