Antisoma AGM update and Interim Management Statement
ASA404 phase III lung cancer trial to include broader range of
London, UK: 20 November 2007 - Cancer drug developer Antisoma plc
(LSE: ASM; USOTC: ATSMY) holds its AGM today. At the meeting, CEO
Glyn Edwards will provide an update on the Company's key pipeline
products and other corporate developments:
"We are making significant advances across our pipeline, and expect
to achieve further important milestones during 2008.
ASA404 - update on plans for phase III trial in lung cancer
Our licensing partner, Novartis, plans to start a pivotal phase III
trial of ASA404 in non-small cell lung cancer (NSCLC) in early 2008.
This trial will now include patients with both major types of NSCLC:
squamous and non-squamous. Previous guidance was that the pivotal
study would be limited to patients with squamous disease. Discussions
with regulatory authorities regarding the trial design are ongoing.
Because more patients are diagnosed with non-squamous than squamous
NSCLC, this change more than doubles the population of NSCLC patients
addressed directly by the phase III trial. Eligibility for the phase
III trial will now be similar to that in our phase II studies, where
we showed a substantial survival benefit with ASA404 in a broad
population of NSCLC patients.
If the phase III trial is successful, applications to market ASA404
for NSCLC will be filed in 2010 or 2011. The drug also has potential
in other cancers. These include prostate cancer, where Antisoma has
reported encouraging interim data from a phase II trial and expects
to report survival findings next year.
AS1411 - AML phase II trial underway, other trials planned
Our randomised phase II trial of AS1411 in AML (acute myeloid
leukaemia) is on track to report initial data in the first half of
The trial compares patients receiving the current standard therapy,
cytarabine, with patients receiving cytarabine plus AS1411. We are
evaluating two different doses of AS1411, 10 and 40 mg/kg/day. The
first report will compare 10 mg/kg/day AS1411 plus cytarabine with
cytarabine alone. The primary endpoint is the proportion of patients
achieving a complete response (disappearance of leukaemia cells)
We are also planning to conduct a phase II trial in renal cancer, an
indication where there was promising evidence of anti-cancer activity
in phase I. The phase II trial will not now start in the first half
of 2008, as previously expected, because we intend to complete
additional preclinical and toxicology work before finalising our
plans. This aims to identify a safe and optimal approach to repeat
dosing of AS1411 for use in the renal cancer trial and other
programmes where repeat dosing may be desirable. In parallel with
this work, we are making plans for a trial in a third cancer
indication, and expect to announce details early next year.
AS1402 and AS1409 - on track with development plans
AS1402 is on track to enter a randomised phase II trial in breast
cancer during 2008. Similarly, we expect to meet our objective of
initiating our phase I trial of AS1409 before the end of 2007.
United States operation established in Princeton
We have opened an office in Princeton, New Jersey, in order to
support our US clinical and regulatory activities. The new office is
headed by Dr Chris Smyth, Head of Clinical Operations, who was
formerly based at our London office. A number of new, experienced
staff have been recruited to meet the needs of our growing clinical
trials programme in the US.
Our pipeline continues to advance, with ASA404 poised to enter phase
III and the first phase II data on AS1411 expected soon. By the end
of 2007, we expect to have four drugs in clinical trials, and our
plans to bring in further drugs for development are progressing well.
With last-reported cash of over £60 million and a strong operational
base, we are well placed both to maximise the value of our existing
assets and to continue the growth of our business."
Glyn Edwards, CEO
Daniel Elger, Director of Communications +44 (0)20 8799 8200
Mark Court/Lisa Baderoon/Rebecca Skye +44 (0)20 7466 5000
Brian Korb +1 646 378 2923
The Trout Group
This Interim Management Statement is published in accordance with the
UK Listing Authority's Disclosure and Transparency Rules, in respect
of the period from 30 June 2007 to 20 November 2007.
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.
Background on Antisoma
Headquartered 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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