Antisoma's phase III trial of AS1413 completes patient enrolment
08:05 08.09.10
London, UK, and Cambridge, MA: 8 September 2010 - Cancer drug developer Antisoma
plc (LSE: ASM; USOTC: ATSMY) announces that the ACCEDE phase III trial of AS1413
(amonafide L-malate) in secondary acute myeloid leukaemia (secondary AML) is now
fully enrolled. Data from the trial are expected in the first half of 2011, with
filings for marketing authorisations to follow if these are positive.
ACCEDE is a single pivotal, randomised, controlled trial in which a regimen of
AS1413 and cytarabine is compared with standard AML remission-induction therapy
of daunorubicin and cytarabine ('7+3'). The primary endpoint of the study is the
rate of complete remission with or without recovery of normal blood counts.
Recruitment into the study has been rapid, especially over the past year.
Over 420 patients from 22 countries have been included, making it the largest
prospective trial ever conducted in patients with secondary AML.
Secondary AML is a significant subgroup of AML that develops from prior
myelodysplastic syndrome (MDS) or follows treatment of another cancer with
chemotherapy or radiotherapy. The disease is often multi-drug resistant and
responds poorly to currently available therapies. A key feature of AS1413, and a
potential advantage over many current AML treatments, is the drug's ability to
evade multi-drug resistance mechanisms.
Professor Richard Stone, MD, Director of the Adult Leukemia Program at the
Dana-Farber Cancer Institute, Boston, and one of the leading investigators in
the AS1413 phase III trial, said: "There is a great need for new treatment
options for patients with poor-risk AML, such as the secondary AML patients
included in the ACCEDE trial. It will be fascinating to see if AS1413 can
deliver on the promise suggested by earlier studies."
Glyn Edwards, CEO of Antisoma, said: "Completion of enrolment in the phase III
trial is a critical milestone in the development of AS1413, and puts us on track
to see the outcome in the near future. I would like to thank all the patients
and physicians who have joined with us in seeking to improve the treatment of
secondary AML."
AS1413 has orphan drug status in both the U.S. and the E.U. for the treatment of
AML and recently received Fast Track status from the U.S. FDA for the treatment
of secondary AML.
Enquiries:
Glyn Edwards, CEO
Daniel Elger, VP Marketing & Communications +44 (0)20 3249 2100
Antisoma plc
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
Buchanan Communications
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. The trial was designed to screen 450
patients in order to enrol 420 eligible patients. Enrolment is now completed.
Data are expected in the first half of 2011 after all patients have completed
treatment under the trial protocol and findings have been collated and analysed.
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.
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 U.K. and the U.S. Please visitwww.antisoma.com for further information
about Antisoma.
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