Prostate Cancer Clinical Trials – AstraZeneca in Late Phases of Prostate Cancer Treatment Trials

AstraZeneca plc is a large Anglo-Swedish pharmaceutical company formed on 6 April 1999 by the remerger of Swedish Astra AB and British Zeneca Group plc. The company has been at the forefront of medical research ever since, with a scandal as recently as 2008 that included potential charges of corruption and cooption in order to win the Nobel Prize in Medicine for Cancer-related Research on the Human Papilloma Virus, by Harald zur Hausen.

In 2005 AstraZeneca announced an arrangement with Astex for the discovery, development and commercialization of novel small molecule inhibitors of Protein Kinase B for use as anti-cancer agents. It also announced an alliance with Schering AG for research and licensing in the area of selective glucocorticoid receptor agonists. And then only in 2007, they declared that they were going into phase III trials for their novel drug ZD4054 for patients with one of the worst kinds of prostate cancer that there is, hormone resistant or hormone refractory prostate cancer.

For a company that has experienced a run of failures of drugs in late-stage clinical trials, this is most certainly a big step. They lost in their trials of Galida for diabetes, Exanta to prevent thrombosis, NXY-059[23] for acute ischemic stroke, Iressa for lung cancer, and AGI-1067 for the prevention of atherosclerosis. Could there then be any reason why anyone should be excited about ZD4054? They have to be desperate at this time, no? With patents expiring on older drugs and the ensuing threat to future revenue growth, could it be that the drug is really ready?

The drug is an oral agent that has done promisingly well in phase II clinical trials. An endothelin A receptor antagonist which blocks cell activity thereby preventing the growth of cancer cells (in some sense); ZD4054 is considered to be some form of improvements for hormonal interventions for prostate cancer patients. The drug works by specific blockade of the ETA receptor, inhibiting tumor cell proliferation, tumor cell survival, tumor angiogenesis and the pathophysiology of bone metastases in prostate cancer patients.

Says John Patterson, AstraZeneca’s Executive Director for Development: “The mainstay treatment for prostate cancer – a cancer driven by naturally occurring male hormones – is hormonal therapy? 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.”

AstraZeneca has indeed done well in the past, with hormotherapeutic drugs ZOLADEX (goserelin) and CASODEX (bicalutamide), first launched in 1987 and 1995 respectively. Phase III studies are randomized controlled multicenter trials on large patient groups (300?3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is. They are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions like prostate cancer definitely is.

I suppose we need to give them a chance to prove themselves; for all we know ZD4054 may be it. Prostate cancer affects close two hundred thousand new men each year in the United States alone, and kills about twenty seven thousand. At the very least, we can afford better treatments for the carcinoma.

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