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Survival Data Presented From Phase II Study of Investigational Drug ZD4054 in Hormone-Resistant Prostate Cancer Patients
Date:9/25/2007

Wide-Ranging ZD4054 Phase III Development Program Announced

WILMINGTON, Del., Sept. 25 /PRNewswire-FirstCall/ -- The results from the randomized, double-blind, placebo-controlled, Phase II EPOC (Endothelin A Proof Of Concept) Study of ZD4054 -- a specific endothelin A (ETA) receptor antagonist -- were delivered today at the 14th European Congress of Clinical Oncology (ECCO, 23-27 September, Barcelona). The data presented today for ZD4054, an investigational compound in development for the treatment of men with hormone resistant prostate cancer (HRPC), showed no differences in progression free survival (PFS) but did report encouraging overall survival (OS) data.(1)

To further evaluate the potential of ZD4054, the Phase III trial program ENTHUSE (ENDOTHELIN A USE), consisting of three studies, will begin this year. The first of these trials is aimed at investigating the efficacy of ZD4054 in metastatic HRPC, while the second will look at its role in nonmetastatic HRPC patients. A third trial will study ZD4054 in combination with docetaxel (Taxotere(TM)) for the treatment of metastatic HRPC.

Nick James, Professor of Clinical Oncology, Institute for Cancer Studies, Birmingham, UK, and principal investigator of the EPOC study said: "Men with advanced prostate cancer are typically treated with hormonal therapies. Whilst these therapies can provide great benefits, most men will become resistant to them. Currently, the only licensed treatment option for metastatic patients shown to improve survival in men with HRPC is chemotherapy with docetaxel."

"The results from the EPOC study suggest that ZD4054 10 mg once daily may have the potential to increase the median overall survival time for men with asymptomatic or mildly symptomatic metastatic HRPC."

EPOC (Endothelin A Proof Of Concept) Phase II findings:

The primary endpoint of the study was progression free survival (PFS) and a secondary endpoint was Overall Survival (OS). The
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SOURCE AstraZeneca
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