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Biotech / Medical : Biotech Stock Picking for Charity - 2006
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To: rkrw who wrote (473)9/24/2006 9:15:19 PM
From: rkrw  Read Replies (1) of 592
 
Too bad wilder also has this one...:-)

Press Release Source: Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals Announces Positive Results of Satraplatin Pivotal Phase 3 Trial in Patients with Hormone-Refractory Prostate Cancer
Sunday September 24, 7:14 pm ET
- Highly statistically significant (p< 0.00001) results seen for PFS (progression free survival) endpoint in favor of satraplatin
- US Regulatory Submission (NDA) expected by year-end 2006, European filing in H1 2007
Conference call to be held Monday, September 25 at 12:00 PM ET (9:00 AM PT) (Tel: 1 866 578 5801 code: 62669828) or www.spectrumpharm.com

IRVINE, Calif., Sept. 24 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced positive results from the Phase 3 satraplatin pivotal registrational trial known as SPARC (Satraplatin and Prednisone Against Refractory Cancer). The trial is evaluating satraplatin, the first orally available platinum-based chemotherapy in advanced clinical development, plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). 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.
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