Antisoma Interim Management Statement
(Thomson Reuters ONE) -
London, UK, and Cambridge, MA: 17 May 2010 - Cancer drug developer Antisoma plc
(LSE: ASM; USOTC: ATSMY) today publishes its Interim Management Statement for
the period from 1 January to 16 May 2010.
Antisoma's CEO, Glyn Edwards, said: "We have two promising cancer drugs, AS1413
and AS1411, both of which we expect to report key trial data during the next
year. Having taken measures to reduce our costs, we expect our cash resources to
take us well past these trial results."
Joint Chairman and CEO's statement
We are determined to bounce back strongly from the recent disappointment over
ASA404, centred on the termination in March of a phase III trial evaluating the
drug as a first-line treatment for lung cancer. We recognise that ASA404 was
considered the Company's most significant asset, but we are confident that
Antisoma's strategy of investment in a diversified portfolio of products remains
sound. We have had to make tough decisions in light of the ASA404 result, but
believe that we have the product assets, people and financial resources to build
value for the future.
AS1413 - rapid recruitment continues in phase III trial
AS1413 is a novel chemotherapy treatment that we are testing in a large,
multi-country, randomised phase III trial in patients with secondary acute
myeloid leukaemia (secondary AML). The trial, known as ACCEDE, has now recruited
over 75% of its target of 450 patients, putting us on course to complete
enrolment this calendar year. Following collection and processing of data, we
expect to announce results of the study during the first half of 2011.
There is interest from potential licensing partners for AS1413. We have decided
to take a pragmatic stance to realising the value of this drug, and have
therefore widened our partnering discussions to include US rights, which we had
previously planned to retain. However, we will only strike a deal ahead of the
phase III data if the terms are sufficiently favourable.
We believe that AS1413 could ultimately find application in a number of blood
cancer settings, with potential sales running to hundreds of millions of dollars
annually. A presentation at the American Association of Cancer Research (AACR)
Annual Meeting during April reinforced the differentiation of AS1413 from
currently available leukaemia treatments and its potential to provide unique
benefits for patients. Three presentations with relevance to AS1413 will be made
at the American Society of Clinical Oncology (ASCO) Annual Meeting in June;
abstracts will be available on the ASCO website (www.asco.org
AS1411 - phase IIb trial now underway
AS1411 is the most advanced aptamer in trials for cancer. It is now in a
90-patient phase IIb study in patients with AML. This trial follows an earlier
randomised phase II trial in AML, which reported positive results at the 2009
ASCO meeting: in that study, two different doses of AS1411 in combination with
cytarabine chemotherapy produced response rates of around 20%, whereas the
response rate in patients receiving chemotherapy alone was 5%. Addition of
AS1411 to chemotherapy was not associated with any significant additional
side-effects. Headline data from the phase IIb study are expected in the first
half of next year.
Recent and forthcoming conference presentations highlight the broad potential of
AS1411. Non-clinical data presented at AACR in April showed activity in a model
of colorectal cancer and positive findings when AS1411 was combined with a
number of approved treatments for blood cancers. At the ASCO meeting we will
have three presentations on AS1411, including updated findings from the first
phase II clinical trial in AML and data from a phase II clinical trial in renal
cancer.
DCAM auto-immune programme progressing towards partnering
We have an important pre-clinical programme in auto-immune diseases. This
comprises a series of molecules collectively known as DCAMs (dendritic cell
auto-immune modulators). They are highly specific, small-molecule inhibitors of
wild-type Flt3, and are designed for oral treatment of various auto-immune
conditions. Positive results have already been achieved in animal models of
inflammatory bowel disease and rheumatoid arthritis, and we are now working
towards establishing a licensing partnership for further development of the
programme.
Cash conservation measures enacted
We are no longer anticipating further revenues from the ASA404 programme, and
have therefore taken steps to reduce our cash utilisation and ensure that our
funds take us comfortably through key clinical data on AS1413 and AS1411. We
announced on 29 March that our unaudited cash position as of the end of February
2010 was GBP 45.1 million.
Board and management changes
Regrettably, we have had to restructure the business and make headcount
reductions as part of our effort to conserve cash resources. As part of the
restructuring, our former Chief Operating Officer, Dr Ursula Ney, has left the
Company and the Antisoma Board. Ursula made a very significant contribution to
the development of Antisoma, and we wish her well with future ventures. Two
other members of the Senior Management Team, Julio Gagne and Kevin Kissane, have
also left the Company, and our total headcount has now been reduced to around
seventy-five.
Outlook
We look forward to a number of important clinical milestones in the near term,
notably phase III data on AS1413 and phase IIb data on AS1411, both of which we
expect during the next year.
Enquiries:
Glyn Edwards, CEO
Daniel Elger, VP, Marketing & Communications +44 (0) 7909 915068
Antisoma plc
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
Buchanan Communications
Seth Lewis +1 617 583 1308
The Trout Group
This Interim Management Statement is published in accordance with the UK Listing
Authority's Disclosure Rules and Transparency Rules, in respect of the period
from 1 January 2010 to 16 May 2010.
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
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 visitwww.antisoma.co
further information about Antisoma.
[HUG#1416003]
Unternehmensinformation / Kurzprofil:
Datum: 17.05.2010 - 08:00 Uhr
Sprache: Deutsch
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