Final data from Antisoma's AS1404 lung cancer trial show clear survival benefit
27/09/2006 8:01am
UK Regulatory
London, UK: 27 September 2006 - Cancer drug developer Antisoma plc
(LSE: ASM, US OTC: ATSMY) today announces final data from its phase
II trial of AS1404 in non-small cell lung cancer. These show a very
substantial survival benefit.
Patients who received AS1404 on top of standard chemotherapy had a
median survival of 14.0 months, compared with 8.8 months in patients
treated with chemotherapy alone. This 5.2-month difference is one of
the largest ever seen in a randomised controlled trial combining a
novel agent with first-line chemotherapy for lung cancer. Across the
duration of the trial, patients treated with AS1404 had a 27% lower
risk of dying than those receiving chemotherapy alone. Safety data
from the trial were also encouraging. The addition of AS1404 to
chemotherapy was well tolerated. These findings extend those
announced in June and strongly support Antisoma's plans for a phase
III trial in lung cancer.
The lung cancer study is one of three phase II trials of AS1404.
Positive PSA response data were recently announced from a trial in
prostate cancer and encouraging early data have been presented from
an ovarian cancer study. Antisoma is currently in talks with a number
of companies with a view to licensing AS1404.
Dr Mark McKeage of the University of Auckland, New Zealand, one of
the Principal Investigators in the AS1404 lung cancer study, said:
"It is great to see this large survival benefit with AS1404 in lung
cancer patients. This makes me feel very optimistic as we proceed
into phase III testing"
Commenting, Glyn Edwards, CEO of Antisoma, said: "Survival is the
gold standard by which cancer drugs are judged and this news is
therefore very exciting."
Enquiries:
Glyn Edwards, Chief Executive Officer
Daniel Elger, Director of Communications +44
(0)7909 915 068
Antisoma plc
Mark Court/Lisa Baderoon/Rebecca Skye Dietrich
Buchanan Communications
+44 (0)20 7466 5000
Antisoma disclaimer
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.
Details of the lung cancer study
The AS1404 phase II trial in lung cancer was a randomised controlled
trial which enrolled patients receiving first-line chemotherapy
treatment for stage IIIb or IV non-small cell lung cancer. Patients
were randomly assigned to receive either AS1404 plus standard
chemotherapy (carboplatin and paclitaxel) or standard chemotherapy
alone. Seventy patients were evaluable for efficacy, 34 of whom
received AS1404 plus chemotherapy while 36 received chemotherapy
alone. The trial was conducted at hospitals in France, Germany,
Australia and New Zealand.
Background on AS1404
AS1404 (DMXAA) is a small-molecule vascular disrupting agent which
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. CRUK had supported
two phase I studies in the UK and New Zealand.
Background on Antisoma
Based in London, UK, Antisoma is a biopharmaceutical company that
develops novel products for the treatment of cancer. Antisoma fills
its development pipeline by acquiring promising new product
candidates from internationally recognised academic or cancer
research institutions. Its core activity is the preclinical and
clinical development of these drug candidates. Please visit
www.antisoma.com for further information.
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