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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

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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