Antisoma to amend ACCEDE phase III study of AS1413
(Thomson Reuters ONE) - London, UK, and Cambridge, MA: 08 October 2009 Antisoma announcesthat, following discussions with FDA and trial investigators, itplans to amend the primary endpoint in the ACCEDE study of AS1413.The ACCEDE study is an ongoing randomised, controlled phase III trialthat compares AS1413 plus cytarabine with daunorubicin pluscytarabine in patients newly diagnosed with secondary acute myeloidleukaemia (secondary AML).The primary endpoint of the trial will continue to be based onremission rate, defined as the proportion of patients who achievecomplete remission (CR) or complete remission with incomplete bloodcount recovery (CRi). However, the requirement for confirmation ofremission before further intervention will be removed. The revisedprimary endpoint will therefore be initial remission rate rather thanconfirmed remission rate. Confirmed remission rate will become asecondary endpoint, alongside duration of remission and overallsurvival.The primary endpoint is being changed because a number of trialinvestigators considered it inappropriate to perform additional bonemarrow sampling to confirm CR or CRi before instigatingpost-remission therapy. Where patients were proceeding rapidly topost-remission therapy, the need to confirm remission meant a secondinvasive procedure was required within days of the initial test forremission. FDA has recognised that trends in medical practice meanpost-remission therapy is now often started shortly after the initialachievement of remission.Antisoma's decision to change the primary endpoint will mean that theACCEDE study is no longer covered by a Special Protocol Assessment(SPA). FDA has confirmed, however, that the amendment will have noimpact on whether a New Drug Application (NDA) based on results fromACCEDE would be accepted for filing.Commenting on this development, Dr Robert Stuart of the MedicalUniversity of South Carolina, an investigator in the ACCEDE trial,said: "This amendment brings the AS1413 trial in line with currentmedical practice for treatment of AML and reduces the need to conductadditional invasive tests. It will therefore be welcomed byinvestigators and patients. The ACCEDE study is an important andrigorous evaluation of a novel agent for AML patients who don'tbenefit much from currently available drugs."Dr Ursula Ney, Chief Operating Officer of Antisoma, said: "The ACCEDEstudy is the first large, randomised trial to be conducted inpatients with secondary AML. It will provide comparative data on bothremission rates and longer term outcomes in patients receiving AS1413or standard therapy. Our planned amendment is designed to ensure thatwe deliver a well-powered study as well as the range of data neededto fully capture any benefit provided by AS1413. We believe this willput us in the best position to generate successful marketingapplications if the data are positive."Enrolment into the ACCEDE study is on track, with approximately onethird of the target of 450 patients now recruited. Key data,including those critical for regulatory filings, are expected to beavailable in late 2010 or early 2011.Antisoma plc +44 (0)7909 915 068Ursula Ney, Chief Operating OfficerDaniel Elger, VP, Marketing & CommunicationsBuchanan Communications +44 (0)20 7466 5000(All media enquiries)Mark Court, Lisa BaderoonThe Trout Group +1 617 583 1308(US investor enquiries)Seth LewisExcept for the historical information presented, certain mattersdiscussed in this statement are forward looking statements that aresubject to a number of risks and uncertainties that could causeactual results to differ materially from results, performance orachievements expressed or implied by such statements. These risks anduncertainties may be associated with product discovery anddevelopment, including statements regarding the Group's clinicaldevelopment programmes, the expected timing of clinical trials andregulatory filings. Such statements are based on management's currentexpectations, but actual results may differ materially.NotesAbout the AS1413 ACCEDE studyThe ACCEDE (AS1413 (Amonafide) Cytarabine Combination: EvaluatingDrug Efficacy) study is a 450-patient randomised controlled trialthat compares AS1413 plus cytarabine with daunorubicin pluscytarabine in patients with secondary AML (secondary acute myeloidleukaemia). This is a form of AML that evolves from myelodysplasticsyndromes or develops following treatment of other cancers withradiotherapy or chemotherapy. The study is enrolling patients in theUS, Europe, Asia, Latin America and Australia.About AMLAML is a type of cancer in which the bone marrow makes abnormal andimmature blood cells, eventually leading to bone marrow failure. TheAmerican Cancer Society estimates that there will be over 13,000 newcases of AML diagnosed this year in the US alone.About AS1413AS1413 (amonafide L-malate) was added to Antisoma's pipeline throughthe acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413is a DNA intercalator that induces apoptotic signalling by blockingTopoisomerase II binding to DNA. This differs from the actionof classical Topoisomerase II inhibitors, which induce apoptosis bycausing extensive DNA damage. A further distinctive feature of AS1413is its ability to evade Pgp and related transporters responsible formulti-drug resistance (MDR). A pivotal phase III trial is evaluatingAS1413 as a treatment for secondary AML. Patients with secondary AMLoften have multi-drug resistant disease. Antisoma is developingAS1413 independently and plans to commercialise the drug itself inthe US while seeking partnerships for commercialisation in otherterritories.About AntisomaAntisoma is a London Stock Exchange-listed biopharmaceutical companythat develops novel products for the treatment of cancer. The Companyhas operations in the UK and the US. Please visitwww.antisoma.com for further information about Antisoma.---END OF MESSAGE---This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 08.10.2009 - 08:01 Uhr
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