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Survival data presented from phase II study of hormone-resistant prostate cancer patients
Date:9/25/2007

cebo treatment arms. The updated Phase II data presented today show that, patients who received ZD4054 10 mg once daily had a median OS of 24.5 months, patients who received ZD4054 15 mg once daily had a median OS of 23.5 months and the placebo arm had a median OS of 17.3 months.

The side effect profile of ZD4054 in this study included headache, edema and nasal congestion.

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 Phase II EPOC study design: This study recruited a total of 312 asymptomatic or mildly symptomatic HRPC patients with bone metastases who were randomized into one of three treatment arms: 15 mg ZD4054 once daily; 10 mg ZD4054 once daily or a placebo tablet once daily. In addition to study treatment, all men randomized into the study received best supportive care.

Mode of action specific ETA receptor antagonism:

ZD4054 targets the ETA receptor. Inhibition of this receptor is thought to be related to multiple processes that drive tumour growth and spread, including tumour cell proliferation, tumour cell survival, angiogenesis, and the formation of bone metastases.


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Contact: Asa Josefsson
Asa.Josefsson@astrazeneca.com
302-885-4109
Edelman Public Relations
Source:Eurekalert

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