LONDON and CAMBRIDGE, MA--(Marketwire - December 02, 2010) - Antisoma plc (LSE: ASM; USOTC:
ATSMY) today provides an update on its blood cancer programmes and
announces
details of a presentation at the American Society of Hematology (ASH)
Annual
Meeting.
AS1413 phase III data in secondary AML expected Q1 2011
Antisoma announced this week that it expects results from the ACCEDE phase
III
trial of AS1413 in secondary acute myeloid leukaemia (secondary AML) during
the
first quarter of 2011.
Secondary AML represents a significant fraction of AML cases. This form of
the
disease evolves from myelodysplastic syndrome (MDS) or results from
chemotherapy
or radiotherapy treatment for other cancers. Patients respond particularly
poorly to current AML therapies.
Antisoma's ACCEDE trial compares a novel regimen of AS1413 plus cytarabine
with
a standard regimen of daunorubicin and cytarabine. Enrolment of over 420
patients was completed in September. If the trial yields positive data,
Antisoma
plans to file for marketing authorisations.
ASH presentation on secondary AML
A new analysis, to be presented on Sunday at the American Society of
Hematology
(ASH) Annual Meeting in Orlando, FL, will highlight the adverse risk
factors
associated with secondary AML and determinants of prognosis within this
patient
group.
Dr Mikkael Sekeres and collaborators from the Cleveland Clinic analysed a
combined data-set of 165 secondary AML patients, including patients treated
at
their own hospital and participants in the phase II trial of AS1413. Being
male,
over 60 or having adverse cytogenetics were factors particularly associated
with
a poor prognosis. The abstract can be found on the ASH website at
www.hematology.org (abstract no 2139); once presented, the poster will be
available at www.antisoma.com
AS1411 phase IIb trial in AML progressing
As well as AS1413, Antisoma is evaluating its DNA aptamer, AS1411, as a
potential treatment for leukaemias. A phase IIb trial combines AS1411 with
high-
dose cytarabine chemotherapy in patients with relapsed or refractory AML.
The
trial builds on positive data from an earlier trial in similar patients.
Headline findings are expected in the first half of 2011.
Except for the historical information presented, certain matters discussed
in
this announcement 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.
About AS1413 (amonafide L-malate)
AS1413 (amonafide L-malate) was added to Antisoma's pipeline through the
acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413 is a
novel DNA
intercalator that induces apoptotic signalling by blocking topoisomerase II
binding to DNA. This differs from the action of classical topoisomerase II
inhibitors, which induce apoptosis by causing extensive DNA damage. A
further
distinctive feature of AS1413 is its ability to evade Pgp and related
transporters responsible for multi-drug resistance (MDR).
A pivotal phase III trial (ACCEDE) is evaluating AS1413 as a treatment for
secondary AML, a condition often associated with MDR and in which outcomes
with
currently available treatments are poor. An earlier phase II trial showed a
complete remission rate of 39% in patients with secondary AML, a finding
that
compares favourably with data from two previous co-operative group studies
in
which similar patients were treated with standard anthracycline plus
cytarabine
regimens. AS1413 has FDA fast-track designation and orphan drug status for
the
treatment of AML in both the US and the EU.
About AS1411
AS1411 belongs to a new type of drug called aptamers. These drugs are short
pieces of DNA or RNA that fold into three-dimensional structures capable of
targeting particular proteins. AS1411 is a DNA aptamer that targets
nucleolin, a
protein found on the surface of cancer cells. AS1411 was originally
developed by
Dr Paula Bates, Dr John Trent and Prof. Donald Miller at the University of
Alabama and then at the University of Louisville. Antisoma added AS1411 to
its
pipeline when it acquired the Louisville-based company Aptamera Inc. in
2005. A
phase II trial reported higher remission rates and a lack of any
significant
additional toxicity when AS1411 was added to high-dose cytarabine
chemotherapy
as a treatment for relapsed or refractory AML. A phase IIb trial is now
further
evaluating AS1411 in similar patients. AS1411 has orphan drug status for
the
treatment of AML in both the US and the EU.
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 visit www.antisoma.com for further information
about
Antisoma.
[HUG#1467814]
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Source: Antisoma plc via Thomson Reuters ONE
