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Astrazeneca To Start Phase III Trials With ZD4054 - A Novel Treatment For Patients With Hormone Resistant Prostate Cancer

June 25, 2017

AstraZeneca announced it will be moving its novel, oral agent ZD4054 into Phase III development in men with hormone resistant prostate cancer - a disease which affects approximately 60,000 new patients in the US alone each year.[i] The Phase III trial programme will begin before the end of 2007.

The company's decision is based on promising survival data from a randomised Phase II study of ZD4054, its specific endothelin A (ETA) receptor antagonist. Data from the EPOC (Endothelin A Proof Of Concept) study will be presented at the 14th European Congress of Clinical Oncology (ECCO 14, 23-27 September, Barcelona).

"The mainstay treatment for prostate cancer - a cancer driven by naturally occurring male hormones - is hormonal therapy," says John Patterson, AstraZeneca's Executive Director for Development. "Whilst such therapy provides great benefit for many men, the majority of patients eventually become resistant to hormonal treatments. For these men there are currently few proven options apart from chemotherapy, and the prognosis is often poor. ZD4054 offers a novel potential treatment."

The ZD4054 Phase III trial programme will investigate the compound's role as monotherapy in patients with metastatic and non-metastatic hormone resistant prostate cancer. The development programme will also examine ZD4054 in combination with docetaxel (TaxotereTM) in patients with hormone resistant metastatic prostate cancer.

ZD4054 works by specific blockade of the ETA receptor, which may lead to the inhibition of multiple processes in cancer such as tumour cell proliferation, tumour cell survival, tumour angiogenesis and the pathophysiology of bone metastases.[ii] It does so without blocking the ETB receptor, which may provide beneficial biological effects in terms of encouraging apoptosis, the death of unhealthy cells.

AstraZeneca has a well-established prostate cancer franchise based on its leading hormonal treatments ZOLADEX (goserelin), first launched in 1987, and CASODEX (bicalutamide), first launched in 1995.

About Prostate Cancer

Prostate cancer primarily affects men over the age of 50.[iii] 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 males. Prostate cancer is the second most common cancer in men after lung cancer.[iv]

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.475 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

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References:

[i]DaVinci Cancer!MPact 2006
[ii] CD Morris et al - Specific inhibition of the endothelin A receptor with ZD4054: clinical and pre-clinical evidence, British Journal of Cancer (2005) 92
[iii] Kirby RS et al. Prostate cancer and sexual function. Prostate Cancer and Prostatic Diseases 1998:1:179-184
[iv] Cancer Research UK, Prostate Cancer Incidence statistics infoncerresearchuk/cancerstats/types/prostate/incidence/

View drug information on Zoladex.