GPC Biotech AG (GPCB) and Pharmion (PHRM) Report Positive Trial Results
More News related to GPCB
- Notable Mergers and Acquisitions of the Day 2/18: GPCB
- GPC Biotech AG (GPCB) To Merge With Agennix
- GPC Biotech AG (GPCB) Reports That Marketing Authorization Application for Satraplatin is to Be Withdrawn
- Piper Jaffray Downgrades GPC Biotech (GPCB) to Underperform
- StreetInsider.com Pre-Open Movers 10/31
More News related to PHRM
- Pharmion (PHRM) Shareholders Approve Acquisition by Celgene (CELG)
- Cohen's SAC Capital Moves Out of Pharmion (PHRM)
- Cohen's SAC Capital Wants A Higher Bid for Pharmion (PHRM)
- Cohen's SAC Capital Boosts Stake in Pharmion (PHRM) to 8.3%
- Cohen's SAC Capital Discloses 7% Stake in Merger Stock Pharmion (PHRM)
More News related to FDA
- CombinatoRx (CRXX) Publishes Research Demonstrating Improved Selectivity Through Synergistic Combinations
- Spectrum Pharmac (SPPI) Receives Complete Response Letter from FDA for Zevalin
- Lilly (LLY) Receives Fourth FDA Approval for ALIMTA
- Protalix (PLX) Approached by the FDA to Consider Submitting a Treatment Protocol for the Use of prGCD
- ATS Medical (ATSI) Announces FDA Clearance of New ATS Simulus Semi-Rigid Annuloplasty Band
GPC Biotech AG (Nasdaq: GPCB) and Pharmion Corporation (Nasdaq: PHRM) announced positive topline results for the double-blinded, randomized satraplatin Phase 3 registrational trial.
The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer.
The study data show that the results for progression-free survival (PFS) are highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the U.S. and will also serve as the primary basis for a Marketing Authorization Application (MAA) in Europe.
Related Categories
FDAHot List
Stocks Mentioned
+0.00Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
