SOURCE: Antisoma plc

September 08, 2010 02:11 ET

Antisoma's phase III trial of AS1413 completes patient enrolment

LONDON and CAMBRIDGE, MA--(Marketwire - September 8, 2010) - Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the ACCEDE phase III trial of AS1413 (amonafide L-malate) in secondary acute myeloid leukaemia (secondary AML) is now fully enrolled. Data from the trial are expected in the first half of 2011, with filings for marketing authorisations to follow if these are positive.

ACCEDE is a single pivotal, randomised, controlled trial in which a regimen of AS1413 and cytarabine is compared with standard AML remission-induction therapy of daunorubicin and cytarabine ('7+3'). The primary endpoint of the study is the rate of complete remission with or without recovery of normal blood counts.

Recruitment into the study has been rapid, especially over the past year. Over 420 patients from 22 countries have been included, making it the largest prospective trial ever conducted in patients with secondary AML.

Secondary AML is a significant subgroup of AML that develops from prior myelodysplastic syndrome (MDS) or follows treatment of another cancer with chemotherapy or radiotherapy. The disease is often multi-drug resistant and responds poorly to currently available therapies. A key feature of AS1413, and a potential advantage over many current AML treatments, is the drug's ability to evade multi-drug resistance mechanisms.

Professor Richard Stone, MD, Director of the Adult Leukemia Program at the Dana-Farber Cancer Institute, Boston, and one of the leading investigators in the AS1413 phase III trial, said: "There is a great need for new treatment options for patients with poor-risk AML, such as the secondary AML patients included in the ACCEDE trial. It will be fascinating to see if AS1413 can deliver on the promise suggested by earlier studies."

Glyn Edwards, CEO of Antisoma, said: "Completion of enrolment in the phase III trial is a critical milestone in the development of AS1413, and puts us on track to see the outcome in the near future. I would like to thank all the patients and physicians who have joined with us in seeking to improve the treatment of secondary AML."

AS1413 has orphan drug status in both the U.S. and the E.U. for the treatment of AML and recently received Fast Track status from the U.S. FDA for the treatment of secondary 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. The trial was designed to screen 450 patients in order to enrol 420 eligible patients. Enrolment is now completed. Data are expected in the first half of 2011 after all patients have completed treatment under the trial protocol and findings have been collated and analysed.

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 U.K. and the U.S. Please visit www.antisoma.com for further information about Antisoma.


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Source: Antisoma plc via Thomson Reuters ONE

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