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Exploratory Efficacy Analysis Conducted for Long-Term Extension Study in Patients With Prostate Cancer Treated With FIRMAGON® or Crossed Over to FIRMAGON From Leuprolide
Date:5/16/2011

WASHINGTON, May 16, 2011 /PRNewswire/ -- A poster entitled, "Time to Progression in Patients with Prostate Cancer: A Comparison of Continuous Degarelix versus Degarelix Following Leuprolide Treatment," is being presented at the American Urological Association 2011 meeting by E. David Crawford, MD, head of the Section of Urologic Oncology at the University of Colorado Health Sciences Center in Denver, and lead study investigator. The full manuscript has just been accepted and will be published in the September 2011 issue of the Journal of Urology.  Other investigators for the study, sponsored by Ferring Pharmaceuticals Inc., included J.W. Moul, N. Shore, E. van der Meulen, and B.E. Persson.

These latest PSA results were observed in the 5-year extension study portion (CS21A) of a pivotal one-year, open-label, randomized phase III trial (CS21)  that evaluated the efficacy of FIRMAGON, a gonadotropin-releasing hormone (GnRH) antagonist, and leuprolide, a luteinizing hormone-releasing hormone (LHRH) agonist, and formed the primary basis of the approval of FIRMAGON for advanced prostate cancer.    

After one year, 384 patients entered CS21A and 134 who had received leuprolide were re-randomized to receive FIRMAGON.  The purpose of the extension study was to evaluate the safety and tolerability during long-term treatment with once-monthly injections of FIRMAGON 80 mg in patients with prostate cancer.  Exploratory efficacy endpoints were evaluated and included: serum levels of PSA over time, cumulative probability of no PSA failure, serum levels of testosterone over time, cumulative probability of testosterone level maintained at less than or equal to 0.5 ng/dL from Day 28 in CS21 and onwards, and serum levels of testosterone, PSA, LH, and FSH from the time of switch from leuprolide to degarelix.

Both the cumulative probability of no PSA failure and the cumulative probability of testosterone levels below c
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SOURCE Ferring Pharmaceuticals Inc.
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