Antisoma reports outcome of AS1413 phase III trial
London, UK, and Cambridge, MA: 31 January 2011 - Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the ACCEDE phase III trial of AS1413 (amonafide) in secondary acute myeloid leukaemia (secondary AML) did not meet its primary endpoint. Development of AS1413 will be discontinued.
Glyn Edwards, CEO of Antisoma, said: "We have not seen a benefit with AS1413. This is hugely disappointing for patients, investigators, investors and employees. We will now become smaller and focus on maximising the value of our other programmes."
Antisoma's pipeline of products comprises:
AS1411, a novel aptamer drug with potential in blood cancers and solid tumours; early data from the ongoing phase IIb trial in AML show this is likely to be inconclusive, so this trial will be terminated and development will be pursued through other approaches
DCAMs (dendritic cell autoimmune modulators), a programme of small-molecule kinase inhibitors in preclinical development with potential as oral therapeutics for autoimmune diseases, and
PPMID, a new and highly targeted approach to cancer treatment under preclinical development in a collaboration with The Institute of Cancer Research.
As at 31 December 2010, the Company had cash resources of approximately £23.4 million. Steps will be taken immediately to reduce expenditure significantly.
A conference call will be held today at 10 am UK time. This will be available afterwards as a recording on the Antisoma website at www.antisoma.com. Dial-in numbers for the call are as follows: + 44 (0) 20 3140 0693; UK Toll Free: 0800 368 1895; participant pin code: 927336#
Glyn Edwards, CEO
Daniel Elger, VP Marketing & Communications +44 (0)7909 915 068
All media enquiries
Mark Court/Jessica Fontaine
+44 (0)20 7466 5000
US investor enquiries
The Trout Group
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.
The ACCEDE phase III trial of AS1413
ACCEDE was a single pivotal, randomised, controlled trial in which a regimen of AS1413 and cytarabine was compared with standard AML remission-induction therapy of daunorubicin and cytarabine ('7+3') in patients with secondary AML (AML following MDS or chemotherapy/radiotherapy treatment of another cancer). The primary endpoint of the study was the rate of complete remission with or without recovery of normal blood counts.
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 visit www.antisoma.com for further information about Antisoma.