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06-03-2010, 04:19 AM
03/06/2010 (AIOAF/ATSMY) Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia
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 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. 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 (http://www.antisoma.com) for further information about Antisoma.
http://www.antisoma.com/asm/media/press/pr2010/2010-06-03/
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 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. 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 (http://www.antisoma.com) for further information about Antisoma.
http://www.antisoma.com/asm/media/press/pr2010/2010-06-03/