13/01/2009
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 Antisoma plc |
+44 (0)7909 915 068 |
| Mark Court/Lisa Baderoon/Rebecca Skye
Dietrich Buchanan Communications |
+ 44 (0)20 7466 5000 |
| Brian Korb The Trout Group |
+1 646 378 2923 |
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.