London, UK, and Cambridge, MA: 18 March 2010 - Antisoma plc (LSE: ASM; USOTC:
ATSMY) announces that it has started a randomised, controlled, multi-territory,
phase IIb trial of AS1411 in patients with acute myeloid leukaemia (AML).
Dr Ursula Ney, Chief Operating Officer of Antisoma, said: "AML is a devastating
disease for which new treatment options are desperately needed. This phase IIb
trial builds on earlier positive phase II findings, and is designed to pave the
way for a registration trial of AS1411 in AML."
The phase IIb trial is enrolling patients with AML in first relapse or
refractory to one prior treatment. Around 90 patients are being randomised to
three treatment groups. A control group is receiving high-dose cytarabine, a
standard chemotherapy treatment for this patient population. The other two
groups are receiving high-dose cytarabine combined with AS1411 at 40 or 80
mg/kg/day. The trial will compare the three treatment groups with respect to
safety, response rates, period free of leukaemia and survival. Data are expected
next year.
The phase IIb trial follows a randomised phase II trial in AML, which reported
positive results at the 2009 Annual Meeting of the American Society of Clinical
Oncology (ASCO).
Enquiries:
Antisoma plc + 44 (0) 7909 915068
Glyn Edwards,Chief Executive Officer
Daniel Elger,VP, Marketing & Communications
Buchanan Communications +44 (0)20 7466 5000
(All media enquiries)
Mark Court, Lisa Baderoon, Catherine Breen
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.
About the AS1411 trials in AML
The phase IIb trial of AS1411 builds on data
from an earlier phase II study reported at ASCO 2009. It evaluates a higher
maximum dose of AS1411 (80 vs 40 mg/kg/day), uses a higher dose of cytarabine (4
vs 3 g/day) and is testing the drug in a refined patient population (patients in
first relapse or refractory to one prior treatment vs all relapsed or refractory
patients). The new trial is intended to identify the optimal dose of AS1411 for
a pivotal AML trial and to provide a more detailed assessment of the benefit
that could be achieved by adding AS1411 to standard chemotherapy in this
setting. This is important in determining the number of patients to be included
in a phase III registration trial and the design of such a study.
In the earlier phase II trial, patients were randomised to one of three
treatment groups: high-dose cytarabine, high-dose cytarabine plus 10 mg/kg/day
AS1411 or high-dose cytarabine plus 40 mg/kg/day AS1411. Response rates in the
three treatment groups were 5% (1/19 patients), 21% (4/19 patients) and 19%
(4/21 patients), respectively. Addition of AS1411 to high-dose cytarabine was
well tolerated at both the 10 and 40 mg/kg/day doses, with most side-effects
observed being those typically associated with cytarabine treatment.
About AS1411
AS1411 belongs to a new type of drug called aptamers. These drugs
are short pieces of DNA or RNA that fold into three-dimensional structures
capable of targeting particular proteins. AS1411 is a DNA aptamer that targets
nucleolin, a protein found on the surface of cancer cells.
AS1411 was originally developed by Dr Paula Bates, Dr John Trent and Prof.
Donald Miller at the University of Alabama and then at the University of
Louisville. Antisoma added AS1411 to its pipeline when it acquired the
Louisville-based company Aptamera Inc. in 2005.
AS1411 has been granted orphan drug status in both the United States and the
European Union for the treatment of acute myeloid leukaemia (AML). The grants
will provide seven years of market exclusivity in the US and ten years of
exclusivity in the EU if AS1411 is approved for use in AML.
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. It has two drugs in phase III trials:
ASA404, a tumour-vascular disrupting agent, which is partnered with Novartis and
which is under development for lung and breast cancers; and AS1413, a novel DNA
intercalator being evaluated in secondary AML. Please visit www.antisoma.com
for further information about Antisoma.
HUG¿1395089
