ASTRAZENECA HALTS PHASE III TRIAL OF ZIBOTENTAN IN NON-METASTATIC CASTRATE RESISTANT PROSTATE CANCER

ASTRAZENECA HALTS PHASE III TRIAL OF ZIBOTENTAN IN NON-METASTATIC
CASTRATE RESISTANT PROSTATE CANCER

 

AstraZeneca today announced that the phase III ENTHUSE Study 15,
studying zibotentan monotherapy in patients with non-metastatic castrate
resistant prostate cancer (CRPC), will be stopped following the results
of an early efficacy review by the Independent Data Monitoring Committee
(IDMC).  The decision was made after this review indicated that
zibotentan monotherapy was unlikely to meet its primary efficacy
endpoints (progression free survival and overall survival) and therefore
unlikely to benefit patients with non-metastatic CRPC.

AstraZeneca felt it was prudent to take an early view on the progress of
Study 15 following the announcement in September 2010 that ENTHUSE Study
14, evaluating zibotentan monotherapy, did not show a significant
improvement in the primary endpoint of overall survival in patients with
metastatic CRPC.

Study 15 is part of the Phase III clinical trial programme, ENTHUSE,
which was developed to evaluate the efficacy and safety of zibotentan in
extending survival in men with CRPC. The discontinuation of Study 15
concludes the zibotentan monotherapy programme in CRPC. The full data
from Study 15 will be published in due course.

ENTHUSE Study 33 is a trial using zibotentan in combination with
standard chemotherapy in a more advanced metastatic CRPC setting. This
trial will continue and full results are expected in the second half of
2011.

- ENDS -

NOTES TO EDITORS

About zibotentan and the Phase III study programme
Zibotentan is a novel once daily tablet and works by blocking the
endothelin pathway. As prostate cancer advances, this pathway becomes
uncontrolled, which then drives the spread of cancer growth. By blocking
the endothelin A receptor in this pathway, zibotentan can slow tumour
growth and the spread of cancer cells.

The ENTHUSE (Endothelin A Use) clinical trial programme, consists of
thee Phase III clinical studies which were developed to evaluate
zibotentan's efficacy and safety in extending survival in men with CRPC.
With the discontinuation of the monotherapy studies 14 and 15, there is
one remaining study in the ENTHUSE trial programme.

Study 33 will evaluate zibotentan plus chemotherapy, versus chemotherapy
alone, in men whose disease has metastasised and who have been
prescribed treatment with chemotherapy

Prostate Cancer and CRPC
Prostate cancer primarily affects men over the age of 50. It is the most
commonly diagnosed male cancer in many western countries and its
incidence is increasing. Worldwide, more than 670,000 men are diagnosed
with prostate cancer every year, accounting for one in nine of all new
cancers in men. Prostate cancer is the second most common cancer in men
after lung cancer and 1 in 5 men with prostate cancer will develop CRPC.
CRPC is prostate cancer that is no longer responding to treatments that
block the action of testosterone, the naturally occurring hormone that
drives cancer growth. Whilst therapies that block testosterone
(collectively known as hormonal treatments) provide great benefit for
many men, the majority of patients eventually become resistant to
hormonal treatments and develop CRPC.

 

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