SRC Sigmaroc Plc

 
TIDMASM 
 
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. 
 
 
[HUG#1443027] 
 
 
 
 
 
 
 
 
This announcement is distributed by Thomson Reuters on behalf of 
Thomson Reuters clients. The owner of this announcement warrants that: 
(i) the releases contained herein are protected by copyright and 
    other applicable laws; and 
(ii) they are solely responsible for the content, accuracy and 
     originality of the information contained therein. 
 
Source: Antisoma plc via Thomson Reuters ONE 
 

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