Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermitte...( Trial Will Build on Pivotal Phase III...),Health

Trial Will Build on Pivotal Phase III Study for the Treatment of Advanced Prostate Cancer

PARSIPPANY, N.J., April 27 /PRNewswire/ -- Ferring Pharmaceuticals announced today the launch of a Phase IIIB clinical trial of degarelix for injection, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone sensitive advanced prostate cancer. The announcement was made at the 2009 American Urological Association Annual Meeting in Chicago, IL.

The Phase IIIB trial will investigate the use of degarelix for intermittent androgen deprivation therapy (IADT) in patients with advanced prostate cancer who have rising serum PSA levels after previous curative therapies. The study will compare IADT to continuous androgen deprivation therapy (ADT) for 14 months with either leuprolide or degarelix. The trial evaluates whether IADT minimizes the negative effects of ADT and maximizes quality of life, while maintaining tumor response as measured by PSA suppression.

"Intermittent androgen deprivation therapy is a commonly employed treatment for men with biochemical failure, however it needs to be evaluated in a randomized clinical trial," says Dr. E. David Crawford, Head Urologic Oncology, University of Colorado, Denver and a trial investigator. "There is potential value in combining the rapid, sustained suppression of testosterone that degarelix offers in this treatment. IADT appears to improve patient quality of life and that will also be evaluated."

Physicians interested in serving as trial investigators should call 1-973-796-1600 to speak with Ferring Pharmaceuticals' Medical Information office.

Degarelix Phase III Trials

Phase III pivotal studies showed that degarelix is as effective as leuprolide (Lupron Depot(R))(*)in reducing and sustaining castrate levels
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