Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia
(Thomson Reuters ONE) -
London, UK, and Cambridge, MA: 3 June 2010 - Cancer drug developer Antisoma plc
(LSE: ASM; USOTC: ATSMY) today announces that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to the Company's novel
DNA intercalator, AS1413 (amonafide L-malate), for the treatment of secondary
acute myeloid leukaemia (secondary AML).
The FDA's Fast Track programme is designed to facilitate the development of new
drugs that have shown the potential to address an unmet medical need in a
serious or life-threatening disease. Fast Track designated drugs ordinarily
qualify for Priority Review, an expedited review process available to drugs that
offer major advances in treatment or provide a treatment where no adequate
therapy exists.
Glyn Edwards, CEO of Antisoma, said "We're very pleased to have gained FDA Fast
Track status for AS1413. This drug could represent a major advance in the
options available to patients with secondary AML, and we look forward to
completing the ongoing phase III trial and sharing the data with FDA and other
regulators."
AS1413 already has orphan drug status in both the U.S. and the E.U. for the
treatment of 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 Communication
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. 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 UK and the US. Please visit www.antisoma.com
for further information about Antisoma.
[HUG#1421244]
Unternehmensinformation / Kurzprofil:
Datum: 03.06.2010 - 08:00 Uhr
Sprache: Deutsch
News-ID 21907
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