London, UK, and Cambridge, MA: 13 October 2009 - Antisoma plc (LSE:
ASM; USOTC: ATSMY) announces that its aptamer drug 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.
Positive phase II data for AS1411 in AML were presented at the 2008
ASH and 2009 ASCO meetings. Addition of AS1411 to high-dose
cytarabine increased response rates without significantly increasing
side-effects in patients with relapsed or refractory AML. Phase IIb
trials are now planned: the first is expected to start in early 2010.
Should this yield positive findings, rapid progress into a
registration trial is anticipated.
AS1411 already has orphan drug status in both the US and the EU for
the treatment of renal cancer. A phase II trial in renal cancer is
ongoing, and expected to report initial data before the end of this
year.
Glyn Edwards, Antisoma's CEO, said: "Gaining orphan drug status in
AML further strengthens the exclusivity position of AS1411 in a
setting where we have positive phase II data. This is an exciting
time for AS1411, with phase II data in renal cancer coming soon and
our investigation of the compound in AML progressing to the next
stage."
Enquiries:
Antisoma plc
Glyn Edwards, CEO
Daniel Elger, VP Marketing & Communications +44 (0) 7909 915 068
Buchanan Communications (media enquiries)
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
The Trout Group (US investor
enquiries)
Seth Lewis +1 617 583 1308
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 AML (acute myeloid leukaemia)
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 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.
About orphan drug status
The US Orphan Drug Act and European Orphan legislation are designed
to stimulate the development of drugs for conditions affecting fewer
than a defined number of patients by providing additional incentives
to developers of such drugs. One of the most valuable of these
incentives is a period of market exclusivity. In the US, orphan drug
status confers a seven-year period of exclusivity after approval in
the given indication. In the EU, a ten-year period of exclusivity is
provided. Other incentives include regulatory guidance from the
competent authority, fee reductions and, in the US, tax credits.
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.
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