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

ce-daily oral dosing.

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 PFS data did not show a statistically significant difference between ZD4054 and placebo treatment arms. However, preliminary survival data suggested an improvement in overall survival. The Phase II data presented today show that, at further follow-up, 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), translating into an improved median OS of 24.5 months with ZD4054 10mg once-daily compared with 17.3 months in the placebo arm.

Patients who received ZD4054 15mg once-daily experienced a 35 percent reduction in risk of death (HR 0.65; 80 percent CI 0.49, 0.86), again translating into an improved median OS of 23.5 months with ZD4054 15mg once-daily compared with 17.3 months in the placebo arm.

The OS results were as follows:

Intent-to-treat population ZD4054 15mg ZD4054 10mg Placebo
Number of patients 98 107 107
Number of deaths 34 33 51
Median overall survival (months) 23.5 24.5 17.3
Hazard ratio versus placebo 0.65 0.55
80 percent CI 0.49, 0.86 0.41, 0.73

It is usual to use PFS as an endpoint in Phase II studies, however it can be difficult to measure accurately in patients with metastatic HRPC. Overall survival is an unambiguous endpoint and clearly an important outcome for patients, commented Professor Nick James.

PFS in this study was measured through clinical or radiological evidence of disease worsening, or worsening of disease-related pain. However, patients with metastatic HRPC can typically have multiple bone metastases, making assessments of further changes in bone metastases difficult.

The EPOC data suggest that ZD4054 once-daily coul
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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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