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Phase II study shows HRPC patients with bone metastases see improved survival with ZD4054
Date:9/25/2007

Macclesfield, UK, 25 September 2007. New Phase II data presented today suggest that ZD4054, a novel compound in development for the treatment of men with Hormone Resistant Prostate Cancer (HRPC), could offer a promising improvement in overall survival in men with metastatic HRPC who were asymptomatic or mildly symptomatic for pain.1 Patients who received ZD4054 10mg once-daily experienced a 45 percent reduction in the risk of death compared to placebo (HR 0.55; 80 percent CI 0.41, 0.73).1

To further evaluate ZD4054s potential, the Phase III trial programme 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 non-metastatic HRPC patients. A third trial will study ZD4054 in combination with docetaxel (TaxotereTM) for the treatment of metastatic HRPC.

The results from the randomised, 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).

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 promising results from the EPOC study suggest that ZD4054 10mg once-daily has the potential to increase the median overall survival time for men with asymptomatic or mildly symptomatic metastatic HRPC, with the benefit of a manageable side-effect profile and the convenience of on
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Contact: Aoife Gallagher
aoife_gallagher@uk.cohnwolfe.com
44-078-943-86422
Cohn & Wolfe Healthcare, London
Source:Eurekalert

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