You are here
Satraplatin Phase III Trial Sponsors Receive Advice Letter From European Review Agency
WALTHAM/BOSTON, Mass. and PRINCETON, N.J., Feb. 3 /PRNewswire-FirstCall/ -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDax 30) today announced that it has received a Scientific Advice letter from the European Agency for the Evaluation of Medicinal Products (EMEA), enabling the Company to proceed with its registrational plans in Europe using the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial. The SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as a second-line chemotherapy regimen for treating patients with hormone-refractory prostate cancer (HRPC). The SPARC trial was initiated in the U.S. in September 2003, following successful completion of a Special Protocol Assessment and an "End of Phase 2" meeting with the U.S. Food and Drug Administration (FDA).
The provision of Scientific Advice is a process by which companies can gain advice from the EMEA regarding the conduct of various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products. Such advice is important for the success of registrational clinical trials in Europe and helps to establish a meaningful dialogue between the Agency and a Sponsor. Scientific Advice received from the EMEA is applicable throughout the European Union.
"We are very pleased to proceed with the SPARC trial in Europe," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development of GPC Biotech. "Our discussions with the EMEA have been very constructive and will allow us to use the same registrational trial in both Europe and the U.S. We will continue to work closely with the EMEA throughout the trial process."
Prostate cancer is the most common cancer among men in the U.S. Over 220,000 new U.S. cases were anticipated during 2003, and over 70,000 patients in the United States are currently estimated to have hormone-refractory prostate cancer. According to recent statistics, there were over 140,000 new cases of prostate cancer in Europe in one year, and approximately 60,000 men died from the disease. Thus, there exists an unmet medical need for additional treatment options for men with advanced prostate cancer in both Europe and the U.S.
In September 2003, GPC Biotech initiated in the U.S. what is now a multicenter, multi-national, randomized study - the SPARC trial - to evaluate satraplatin plus prednisone versus placebo plus prednisone as a second-line chemotherapy regimen for treating patients with HRPC. The primary endpoint of the trial is based upon disease progression. The study's objectives also include the evaluation of pain control and overall survival, as well as an assessment of drug safety in this patient population.
Satraplatin is a member of the platinum family of compounds, but unlike platinum compounds currently on the market, satraplatin is orally administered. A registrational Phase 3 trial - the SPARC trial - for satraplatin in HRPC has been initiated, following successful completion of a Special Protocol Assessment (SPA) by the FDA. The trial is now expanding in Europe following receipt of a Scientific Advice letter from the EMEA. In the U.S., the FDA has also granted fast track designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC. Positive results from a randomized, 50-patient study in HRPC were presented at the ASCO Annual Meeting in June 2003. These data demonstrated statistical significance in time to disease progression, doubling progression-free survival in the satraplatin-treated group versus the control group. Phase 2 trials have been successfully completed in HRPC, as well as in ovarian cancer and small-cell lung cancer. Further information on satraplatin can be found in the Drug Discovery and Development section of the Company's Web site at http://www.gpc-/ biotech.com.
Source: GPC Biotech AG