Survival Data Presented From Phase II Study of Investigational Drug ZD4054 in Hormone-Resistant Prostate Cance... (PFS data did notshow a statistically sig...)

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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

PFS data did not show a statistically significant difference between ZD4054 and placebo 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% 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. In
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Survival Data Presented From Phase II Study of Investigational Drug ZD4054 in Hormone-Resistant Prostate Cance...(PFS data did notshow a statistically sig...)