GPC Biotech AG has received written confirmation from the FDA (U.S. Food and Drug Administration) that the Company may initiate a Phase 3 registrational trial with satraplatin plus prednisone in patients with hormone-refractory prostate cancer who have failed prior treatment with chemotherapy. This notification is the culmination of the Company's satisfactory completion of both a Special Protocol Assessment (SPA) and an "End of Phase 2" meeting with the FDA.
GPC Biotech requested a review of the Phase 3 clinical trial protocol under an SPA, part of procedures published by the FDA in 2002 to encourage a meaningful dialogue between the Agency and a drug developer prior to the initiation of registrational studies. Under this SPA program, the FDA evaluates whether the protocol for a clinical trial is adequate to meet scientific and regulatory requirements for marketing approval of the drug by the FDA. The satraplatin Phase 3 clinical trial protocol has now successfully completed this SPA process.
In addition, GPC Biotech held an "End of Phase 2" meeting with the FDA. The purposes of this type of meeting include: assessing the safety of the drug regimen to be tested in the Phase 3 trial, evaluating the Phase 3 plan, and identifying any additional information that will be needed to support a marketing application. The combination of this meeting and the SPA provided GPC Biotech the opportunity to hold comprehensive and meaningful discussions with the FDA about the many components that will eventually be part of its U.S. NDA (New Drug Application) filing.
The satraplatin registrational Phase 3 study will assess the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy regimen in patients with hormone-refractory prostate cancer (HRPC). This will be a multicenter, global, randomized study. It is modeled on the smaller Phase 3 trial successfully conducted by the EORTC (European Organization for Research and Treatment of Cancer). The GPC Biotech Phase 3 registrational trial will compare satraplatin plus prednisone versus prednisone alone. Prednisone is a synthetic hormone often used to treat advanced prostate cancer.
The primary endpoint of the registrational trial for accelerated approval will be the time to disease progression. The study's objectives also will include the evaluation of pain control and survival, as well as an assessment of drug safety in this patient population.