Atlanta, Georgia, and London, UK: 4 June 2006 Antisoma announces the
presentation at ASCO of positive data from a phase II lung cancer
study of its vascular disrupting agent AS1404 (DMXAA). Patients
receiving AS1404 in addition to standard chemotherapy showed
increased tumour response rates, longer time to disease progression
and enhanced survival compared with patients receiving standard
chemotherapy alone.
Antisoma also announces that it has regained all rights to AS1404
from Roche, and plans to take the drug forward promptly into a phase
III trial in lung cancer. Extensive preparations have already been
made to allow seamless progression to the next stage of development.
Dr Mark McKeage of the University of Auckland, New Zealand, one of
the Principal Investigators in the AS1404 lung cancer study and the
presenter of the findings at ASCO, said: "These are undoubtedly some
of the most interesting data to emerge in lung cancer in recent
years, and I look forward to seeing the drug proceed rapidly into
phase III trials."
Antisoma's CEO Glyn Edwards said: "This is a great moment for
Antisoma and a credit to all those who have backed or collaborated
with us to achieve this success. AS1404 has shown proof of concept in
a robust study in lung cancer, which represents one of the largest
market opportunities in oncology, and is now firmly established as
the leading drug in the class of vascular disrupting agents. We are
excited by the potential of AS1404 to bring benefits to patients with
a variety of cancers and look forward to seeing further data from
trials in lung cancer and other tumour types. We are also delighted
to have regained full rights to the drug, and will endeavour to
maximise shareholder value by advancing AS1404 ourselves while also
considering the merits of any offers from new potential partners."
Details of the phase II results in lung cancer
The phase II data presented at ASCO are from a randomised controlled
four-nation trial which enrolled patients receiving first-line
chemotherapy treatment for stage IIIb or IV non-small cell lung
cancer. Seventy patients were evaluable for efficacy, 34 of whom
received AS1404 plus standard chemotherapy while 36 received standard
chemotherapy alone. Projected six-month survival rates are 82.0% for
patients receiving AS1404 and 54.8% for patients receiving standard
chemotherapy. Projected median survival is currently 12.0 months with
AS1404 and 7.6 months in the standard chemotherapy group. Data on
time to tumour progression and tumour responses also show an
advantage with AS1404, with median time to progression longer by 17
days (132 vs 115 days for the standard chemotherapy group) and a
higher tumour response rate (31.2% with AS1404 vs 22.2% with standard
chemotherapy).
Safety findings from the study show that addition of AS1404 to
chemotherapy was well tolerated and that there was no requirement to
lower doses of the chemotherapy agents. The study included patients
with both squamous and non-squamous tumour histologies; no
differences in safety were observed between these groups.
In parallel with preparations for phase III, Antisoma is conducting
an extension study in which additional lung cancer patients are being
treated with 1800 mg/m2 AS1404 (a higher dose than the 1200 mg/m2
dose that was standard in the phase II trial). Data from this study
will be presented at future scientific meetings, as will findings
from a phase II trial in prostate cancer and further data from a
phase II trial in ovarian cancer, from which initial findings have
also been presented at ASCO 2006 (see separate announcement).
According to the World Health Organisation, there are more than 1.2
million cases worldwide of lung and bronchial cancer each year,
causing approximately 1.1 million deaths. The American Cancer Society
(ACS) estimates that around 173,000 people will be diagnosed with
lung cancer in the United States in 2006. The US National Cancer
Institute reports that lung cancer is the single largest cause of
deaths from cancer in the US, responsible for nearly 30% of all
cancer deaths. Non-small cell lung cancer is the most common form of
the disease and accounts for more than 80% of all lung cancers.
The ASCO poster in which the lung cancer data were presented is
reproduced on the Antisoma website at www.antisoma.co.uk, along with
a webcast about the company's ASCO presentations.
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
Antisoma disclaimer
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.
Further details of the AS1404 phase II trial in lung cancer
The AS1404 lung cancer trial has been conducted at hospitals in
France, Germany, Australia and New Zealand. Half of the patients in
the study have received AS1404 plus chemotherapy (carboplatin and
paclitaxel) while the other half have received chemotherapy alone.
Promising preliminary response findings from the study were reported
in October 2005, while the ASCO presentation includes more mature
data covering multiple endpoints.
Endpoints in the study include:
* response rate, assessed using RECIST (Response Evaluation
Criteria In Solid Tumours). Possible outcomes include complete
response (disappearance of all tumours), partial response (more
than 30% but less than 100% reduction in the sum of the longest
diameters of 'target' tumour lesions), stable disease (between a
30% reduction and a 20% increase in the sum of lesion
measurements) and progressive disease (greater than 20% increase
in the sum of lesion sizes or appearance of new lesions);
response rates quoted in this release are derived from
independent assessment of patient scans by a reader blinded to
the treatment received; 2 patients in the AS1404 group and 9
patients in the standard chemotherapy group could not be
evaluated in the independent assessment of response.
* time to tumour progression, assessed as the time from the start
of treatment until the first recording of progressive disease
according to RECIST; the values quoted in this release are based
on independent assessment of scans and derive from an uncensored
analysis of time to progression data
* survival, defined as the time from the start of treatment until
death from any cause; follow up of patients is ongoing and
present survival projections have been made after a total of 21
deaths.
Background on AS1404
AS1404 (DMXAA) is a small-molecule vascular disrupting agent (VDA).
It is the first member of this class of drugs to report positive
efficacy data from a controlled study. AS1404 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 Technologies) in August 2001.
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.co.uk for further information about Antisoma.
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