- Overall survival results do not achieve statistical significance - GPC Biotech schedules conference call for Wednesday, October 31st, 8:30
AM ET/13:30 CET
BOULDER, Colo., MARTINSRIED, Germany, MUNICH, Germany and PRINCETON, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) and GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced topline overall survival results for the double-blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.
Based on the results announced today, GPC Biotech is re-evaluating its development plans for satraplatin, including SPERA, the Satraplatin Expanded Rapid Access protocol in the U.S.
"We are extremely disappointed with the findings we announced today,"
said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC
Biotech. "We are currently discussing with our partners, Pharmion and
Yakult, plans for the future development of satraplatin. I would like to
warmly thank and recognize the contributions of the investigators and
patients, as well as their families, who participated in the SPARC
|SOURCE Pharmion Corporation|
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