http://www.ariva.de/..._III_trial_in_second_line_lung_cancer_n2862806
ASA404 enters pivotal phase III trial in second-line lung cancer
08:05 13.01.09
London, UK, and Cambridge, MA, 13 January 2009 - Antisoma plc
(LSE:ASM; USOTC: ATSMY) announces that 'ATTRACT-2', a phase III trial
testing ASA404 as a second-line treatment for non-small cell lung
cancer (NSCLC), is now underway. This is a single pivotal study
designed to support applications to market ASA404 for lung cancer
patients who have received one previous round of treatment. A
separate, ongoing pivotal trial, ATTRACT-1, is evaluating ASA404 in
patients receiving their first treatment for NSCLC.
Glyn Edwards, Antisoma's CEO, said: "We're delighted that our partner
Novartis has decided to explore the potential of ASA404 in previously
treated as well as newly diagnosed lung cancer patients. This will
help to ensure that a wide range of patients could benefit from the
drug."
About the ATTRACT-2 phase III trial
ATTRACT-2 (Anti-vascular Targeted Therapy: Researching ASA404 in
Cancer Treatment-2) is a randomised, double-blind,
placebo-controlled, multi-centre, multi-country phase III trial that
will include approximately 900 patients receiving their second
treatment for stage IIIb/IV NSCLC of either squamous or non-squamous
histology. It is open to patients who previously received only
chemotherapy and to patients who received chemotherapy plus
bevacizumab or cetuximab as their first-line treatment. Patients will
be randomly assigned to receive either ASA404 1800 mg/m2 plus
docetaxel or a placebo plus docetaxel. The primary endpoint of the
trial is overall survival. Before the final analysis there will be a
single interim look, which is expected to occur during 2010. The
study is expected to be completed in 2011.
About NSCLC
Lung cancer is the number one cause of cancer death for both men and
women worldwide, with 1.2 million new cases per year and around
920,000 deaths. Approximately 85-90% of all lung cancer cases are
NSCLC.
About ASA404
ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting
Agent (Tumour-VDA) which selectively targets the blood vessels that
nourish tumours. The drug was discovered by Professors Bruce Baguley
and William Denny and their teams at the Auckland Cancer Society
Research Centre, University of Auckland, New Zealand. It was
in-licensed by Antisoma from Cancer Research Ventures Limited (now
Cancer Research Technology), the development and commercialisation
company of the Cancer Research Campaign (now Cancer Research UK), in
August 2001. Worldwide rights to the drug were licensed to Novartis
AG in April 2007.
About ASA404 in NSCLC
ASA404 improved survival by 5 months in patients with NSCLC when
added to first-line carboplatin and paclitaxel chemotherapy in a
randomised phase II trial. A second, single-arm, phase II trial also
reported positive results with ASA404 in the same patient group. A
pivotal phase III trial, ATTRACT-1, is evaluating ASA404 in
combination with carboplatin and paclitaxel in the first-line
treatment of NSCLC. The ATTRACT-2 phase III trial is the first study
to investigate ASA404 as a second-line treatment for NSCLC. In this
trial, ASA404 is combined with docetaxel, which, like paclitaxel,
belongs to the taxane class of drugs, and which is widely used in the
second-line treatment of NSCLC.
About Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical company
that develops novel products for the treatment of cancer. The Company
has operations in the UK and the US. Please visit www.antisoma.com
for further information about Antisoma.
Enquiries:
Glyn Edwards, CEO
Daniel Elger, Director of Communications +44 (0)7909 915 068
Antisoma plc
Mark Court/Lisa Baderoon/Rebecca Skye +44 (0)20 7466 5000
Dietrich
Buchanan Communications
Brian Korb +1 646 378 2923
The Trout Group
Except for the historical information presented, certain matters
discussed in this statement are forward looking statements that are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from results, performance or
achievements expressed or implied by such statements. These risks and
uncertainties may be associated with product discovery and
development, including statements regarding the company's clinical
development programmes, the expected timing of clinical trials and
regulatory filings. Such statements are based on management's current
expectations, but actual results may differ materially. -----------
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