London, UK, and Cambridge, MA, 15 August 2008 - Antisoma plc
(LSE:ASM; USOTC: ATSMY) today announced survival data from its phase
II study of ASA404 in hormone-refractory prostate cancer, in which
patients were randomised to receive either 1200 mg/m2 ASA404 plus the
chemotherapy drug docetaxel or a control treatment of docetaxel
The hazard ratio expressing the relative risk of death in the ASA404
and control groups favoured the ASA404 group (hazard ratio 0.8; 95%
confidence intervals 0.46-1.39). Median survival in the two groups
was similar at 17.0 and 17.2 months, respectively, while two-year
survival was 33% with ASA404 and 23% in the control group.
Previously reported findings from the same trial have shown higher
tumour response rates and markedly higher PSA response rates in
patients receiving ASA404.
Antisoma's partner Novartis is considering what the next steps should
be in prostate cancer as part of a wider analysis of potential
indications for development. A phase III development programme is
already ongoing in lung cancer, and plans for development in other
indications are being considered.
Glyn Edwards, Antisoma's CEO, said: "Following the very positive
phase II data in lung cancer, it does not surprise us to see further
evidence of ASA404's activity in prostate cancer. With its unique
mode of action as a tumour-vascular disrupting agent, ASA404 has
potential against a variety of solid tumours."
A webcast and conference call will be held today at 2pm BST/ 9am EDT.
The webcast can be accessed via Antisoma's website at
http://www.antisoma.com/ and the call by dialling +44 (0)20 8609 1435
(UK toll-free 0808 109 1498; US toll-free 1866 793 4279) and using
the participant PIN code 965983#. A recording will also be available
afterwards on the Antisoma website.
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
The Trout Group +1 646 378 2923
ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting Agent
(Tumour-VDA) 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.
Worldwide rights to the drug were licensed to Novartis AG in April
2007. ASA404 is currently being tested in a phase III pivotal study
in the first-line treatment of non-small cell lung cancer (NSCLC),
and will enter a second phase III pivotal study in the second-line
treatment of NSCLC later this year. ASA404 may have potential against
a number of solid tumours and is regarded as having the potential to
achieve blockbuster sales.
About the ASA404 trial in prostate cancer
Patients enrolled in the ASA404 prostate cancer phase II trial had
metastatic hormone-refractory prostate cancer. Seventy-four patients
were randomised to receive either docetaxel alone or docetaxel plus
ASA404. Endpoints in the study included PSA response rate (the
proportion of patients who showed a sustained 50% decline in the
level of prostate-specific antigen (PSA)), RECIST response rates
(proportion of patients who showed tumour reductions according to the
'Response Evaluation Criteria in Solid Tumours'), time to tumour
progression (TTP; the time before disease recurrence was apparent)
and median survival. Data on PSA response, RECIST response and TTP
have been reported previously, and were as follows in the ASA404 and
control groups, respectively: PSA response 59 vs 37%; RECIST response
23 vs 9%; TTP 7.3 vs 6.9 months. Survival findings are detailed
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.
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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