GPC Biotech AG announced the granting of a European Patent (EP 1 720 540 B1) related to satraplatin, a novel, oral platinum compound. The patent is entitled, "Satraplatin for treating resistant or refractory tumours" and covers certain uses of satraplatin related to the treatment of a cancer or tumour resistant or refractory to a taxane, including docetaxel (Taxotere) and paclitaxel (Taxol). The term of the patent extends up to 2025.
"Docetaxel is the standard of care for the first-line treatment of patients with hormone-refractory prostate cancer, or HRPC, and approximately half of the patients in the satraplatin Phase 3 SPARC trial in second-line HRPC were previously treated with docetaxel," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "With an active filing for satraplatin under review in Europe, we believe this patent will be of particular commercial importance, should satraplatin be approved for HRPC patients whose prior chemotherapy has failed."
The company conducted the SPARC Phase 3 trial evaluating satraplatin in combination with prednisone in the second-line treatment of patients with HRPC. Approximately, 50 per cent of patients recruited into the study had progressive disease following prior treatment with docetaxel. The SPARC trial results showed a statistically significant improvement in progression-free survival in the overall intent-to-treat (ITT) population, as well as in the group of patients who had progressed after receiving docetaxel. While the overall survival results in the overall ITT population did not show a difference between the two treatment arms, there was a positive trend toward improved survival observed in those patients whose disease had progressed after receiving docetaxel, when adjusting for the three significant prognostic factors in the SPARC trial.
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. A Marketing Authorization Application for satraplatin in combination with prednisone is currently under review in Europe for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. A decision on the filing by the European regulators is expected in the second half of 2008. Celgene Corporation is responsible for the regulatory filings for satraplatin and its development and commercialization for Europe and certain other territories.
GPC Biotech also has a license agreement with Yakult Honsha Co. Ltd. under which Yakult has exclusive commercialization rights to satraplatin for Japan and is taking the lead in developing the drug in that territory. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
GPC Biotech AG is a publicly traded biopharmaceutical company focused on new anticancer drugs. GPC Biotech's lead product candidate is satraplatin, an oral platinum compound.