981 0 Kommentare Antisoma´s phase III trial of AS1413 completes patient enrolment

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.