TIDMASM
London, UK, and Cambridge, MA: 08 October 2009 Antisoma announces
that, following discussions with FDA and trial investigators, it
plans to amend the primary endpoint in the ACCEDE study of AS1413.
The ACCEDE study is an ongoing randomised, controlled phase III trial
that compares AS1413 plus cytarabine with daunorubicin plus
cytarabine in patients newly diagnosed with secondary acute myeloid
leukaemia (secondary AML).
The primary endpoint of the trial will continue to be based on
remission rate, defined as the proportion of patients who achieve
complete remission (CR) or complete remission with incomplete blood
count recovery (CRi). However, the requirement for confirmation of
remission before further intervention will be removed. The revised
primary endpoint will therefore be initial remission rate rather than
confirmed remission rate. Confirmed remission rate will become a
secondary endpoint, alongside duration of remission and overall
survival.
The primary endpoint is being changed because a number of trial
investigators considered it inappropriate to perform additional bone
marrow sampling to confirm CR or CRi before instigating
post-remission therapy. Where patients were proceeding rapidly to
post-remission therapy, the need to confirm remission meant a second
invasive procedure was required within days of the initial test for
remission. FDA has recognised that trends in medical practice mean
post-remission therapy is now often started shortly after the initial
achievement of remission.
Antisoma's decision to change the primary endpoint will mean that the
ACCEDE study is no longer covered by a Special Protocol Assessment
(SPA). FDA has confirmed, however, that the amendment will have no
impact on whether a New Drug Application (NDA) based on results from
ACCEDE would be accepted for filing.
Commenting on this development, Dr Robert Stuart of the Medical
University of South Carolina, an investigator in the ACCEDE trial,
said: "This amendment brings the AS1413 trial in line with current
medical practice for treatment of AML and reduces the need to conduct
additional invasive tests. It will therefore be welcomed by
investigators and patients. The ACCEDE study is an important and
rigorous evaluation of a novel agent for AML patients who don't
benefit much from currently available drugs."
Dr Ursula Ney, Chief Operating Officer of Antisoma, said: "The ACCEDE
study is the first large, randomised trial to be conducted in
patients with secondary AML. It will provide comparative data on both
remission rates and longer term outcomes in patients receiving AS1413
or standard therapy. Our planned amendment is designed to ensure that
we deliver a well-powered study as well as the range of data needed
to fully capture any benefit provided by AS1413. We believe this will
put us in the best position to generate successful marketing
applications if the data are positive."
Enrolment into the ACCEDE study is on track, with approximately one
third of the target of 450 patients now recruited. Key data,
including those critical for regulatory filings, are expected to be
available in late 2010 or early 2011.
Antisoma plc +44 (0)7909 915 068
Ursula Ney, Chief Operating Officer
Daniel Elger, VP, Marketing & Communications
Buchanan Communications +44 (0)20 7466 5000
(All media enquiries)
Mark Court, Lisa Baderoon
The Trout Group +1 617 583 1308
(US investor enquiries)
Seth Lewis
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 Group'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.
Notes
About the AS1413 ACCEDE study
The ACCEDE (AS1413 (Amonafide) Cytarabine Combination: Evaluating
Drug Efficacy) study is a 450-patient randomised controlled trial
that compares AS1413 plus cytarabine with daunorubicin plus
cytarabine in patients with secondary AML (secondary acute myeloid
leukaemia). This is a form of AML that evolves from myelodysplastic
syndromes or develops following treatment of other cancers with
radiotherapy or chemotherapy. The study is enrolling patients in the
US, Europe, Asia, Latin America and Australia.
About AML
AML is a type of cancer in which the bone marrow makes abnormal and
immature blood cells, eventually leading to bone marrow failure. The
American Cancer Society estimates that there will be over 13,000 new
cases of AML diagnosed this year in the US alone.
About AS1413
AS1413 (amonafide L-malate) was added to Antisoma's pipeline through
the acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413
is a 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 is evaluating
AS1413 as a treatment for secondary AML. Patients with secondary AML
often have multi-drug resistant disease. Antisoma is developing
AS1413 independently and plans to commercialise the drug itself in
the US while seeking partnerships for commercialisation in other
territories.
About 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.
=--END OF MESSAGE---
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
|