AstraZeneca

New Study of VEGF Signalling Inhibitor AZD2171 Used in the First-Line Setting for Patients With Advanced NSCLC

    Alderley Park, England, November 23 (ots/PRNewswire) -

    - First patient enrolled into double-blind, randomised, placebo-controlled study to investigate overall survival in a broad NSCLC population

    AstraZeneca (NYSE: AZN) announced today the start of recruitment into a pivotal Phase II/III study of the novel Vascular Endothelial Growth Factor (VEGF) signalling inhibitor, AZD2171, in non-small cell lung cancer (NSCLC). The study is being coordinated by the National Cancer Institute of Canada (NCIC) Clinical Trials Group at Queen's University in Kingston, Ontario. Centres from Canada, as well as from around the world, are participating in the trial. This study is part of a wider ongoing AZD2171 collaboration between the NCIC Clinical Trials Group and AstraZeneca.

    Lung cancer is the most common malignancy worldwide; an estimated 1.2 million new cases are diagnosed each year and over 1 million deaths are attributed to this disease annually.(1) The study will investigate overall survival and tumour response rate in patients with advanced NSCLC by comparing the efficacy of 'doublet' chemotherapy (paclitaxel and carboplatin) plus either a once-daily AZD2171 tablet or once-daily placebo tablet.

    VEGF is a key factor implicated in tumour blood vessel formation (angiogenesis). AZD2171 is one of the most potent inhibitors of VEGF signalling.(1) In particular, the drug inhibits VEGFR-2 (also called KDR), which is the principal receptor through which VEGF exerts its effect on angiogenesis.(2) AZD2171 is a convenient, once-daily tablet; Phase I data show that AZD2171 has promising anti-cancer activity across a range of tumours.(3)

    The co-chairs of the study are Glen Goss and Scott Laurie, both based in Ottawa, Canada. Glen Goss MD, Head, Medical Oncology, Ottawa Hospital Regional Cancer Centre, commented, "AZD2171 is an exciting, novel drug. Based on preclinical experiments, AZD2171 appears to be highly potent at inhibiting the action of VEGF and suppressing angiogenesis, the process by which tumours hijack existing healthy blood vessels and use them to supply blood and nutrients to the tumour."

    NOTES TO EDITORS

    Background

    The study is a randomised, double-blind, placebo-controlled Phase II/III investigation of AZD2171 versus placebo given in combination with standard paclitaxel and carboplatin chemotherapy in a broad population of patients with first-line NSCLC. In the Phase II part of the study, patients will be recruited into the study from centres in Argentina, Australia, Brazil, Canada, New Zealand, Romania, Singapore and USA.

    AZD2171: a potent and selective inhibitor of predominant receptor that drives angiogenesis

    There are three VEGF receptors involved in mediating tumour angiogenesis: two, VEGFR-1 (also known as Flt-1) and VEGFR-2 (also known as 'Kinase inert Domain-containing receptor', KDR), are located on the cell lining (endothelium) of the vascular (blood) system. A third receptor, VEGFR-3 (also called Flt-4), is expressed on the endothelium of the lymphatic system. Current evidence from pre-clinical studies indicates that AZD2171 inhibits all three VEGF receptors. In particular AZD2171 is a potent inhibitor of VEGFR-2, the predominant receptor through which VEGF exerts its effect.(1)

    AZD2171 is an investigational agent in clinical development and has potential for activity in a wide range of tumours as well as for combining with other anti-cancer agents. Phase I data indicate that AZD2171 is generally well tolerated, with dosed related adverse events being diarrhoea, hoarseness, headache and hypertension.(3)

    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 over US$21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology, and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

    About the National Cancer Institute of Canada Clinical Trials Group

    The National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), funded by the Canadian Cancer Society and based at Queen's University in Kingston, Ontario, Canada, develops, conducts and analyses national and international trials of cancer therapy, including trials for new cancer drugs, cancer prevention and supportive care to improve quality of life for people with cancer. Since its inception in 1971, the NCIC CTG has enrolled more than 40,000 patients from Canada and around the world in over 300 clinical trials.

    References

    1. GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0. IARC CancerBase N0.5. Lyon, IARC Press 2001

    2. Wedge SR, Kendrew J, Hennequin LF, et al. Cancer Research 2005, 65: 4389-4400

    3. Drevs J, Medinger M, Mross K et al. Proceedings from ASCO 2005, Abs 3002

ots Originaltext: AstraZeneca
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Contact:
For further information, please contact: Peter Edwards, AstraZeneca,
Tel: +44-(0)1625-232685, Mobile: +44-(0)-7747-118-498,
Peter.s.edwards@astrazeneca.com Catherine Hartley, Shire Health
International, Tel: +44-(0)-20-7108-6500, Mobile:
+44-(0)-7789-008-047



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