AS1413 regimen yields high response rate and durable responses in
patients with secondary AML, a poo
(Thomson Reuters ONE) - London, UK, Cambridge, MA, and New Orleans, LA: 7 December 2009-Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that positive finaldata from a phase II trial of AS1413 in patients with secondary acutemyeloid leukaemia (secondary AML) were presented this weekend at theAmerican Society of Hematology (ASH) meeting in New Orleans.Follow-up of patients has now been completed, and full results areavailable: * Eighty-eight patients with secondary AML received the novel DNA intercalator AS1413 together with cytarabine as first-line (remission-induction) therapy * The remission rate was 42%, with 39% of patients achieving a complete remission and 3% a complete remission with incomplete bone marrow recovery * The median duration of remission was 9.4 months, and 30% of those who achieved remission were still alive 2 years after treatment * Clinical benefit was maintained in older patients, with patients over 60 achieving remission rates and remission durations similar to those of patients under 60 * Median survival for all patients was 6.6 months * The safety profile of the regimen was manageable and acceptable, and consistent with that expected for AML remission-induction therapyDr Harry P. Erba, Associate Professor of Internal Medicine at theUniversity of Michigan Health System, Principal Investigator in thetrial, and presenter of the data at ASH, said: "The phase II study ofAS1413 in secondary AML has produced encouraging data, with a 42%remission rate and a significant fraction of durable responses inthis very poor-risk population. Based on these promising findings, alarge, randomised phase III trial is evaluating AS1413 in patientswith secondary AML."Secondary AML is a well-characterised subset of AML that evolves froma prior myelodysplastic syndrome or develops following radiotherapyor chemotherapy treatment for other cancers. This contrasts with denovo AML, where there is no obvious history leading to the disease. Adiagnosis of secondary AML carries a worse prognosis than de novoAML. Moreover, secondary AML is often associated with other adverserisk factors. Dr Erba added: "Patients with secondary AML have a verypoor prognosis. In the AS1413 phase II study, most patients were over60 and almost half had leukaemic cell karyotypes associated withunfavourable outcome."One adverse risk factor that is common in secondary AML is multi-drugresistance (MDR). This can occur when leukaemic cells producemolecular pumps that expel chemotherapy drugs. MDR affects manydrugs, including the anthracyclines daunorubicin and idarubicin,which are commonly used alongside cytarabine as standardremission-induction treatment for AML. AS1413, by contrast, isunaffected by MDR, since it evades the major MDR mechanisms,including Pgp, MRP-1 and BCRP. AS1413 has been shown to retainactivity against MDR-positive leukaemia cells, and this could be areason for the observed difference in remission rates between theAS1413 phase II trial and previous trials that used anthracyclines insimilar patients, where complete remission rates of 24% and 26% werereported.Treatment regimens based on AS1413 may be preferable toanthracycline-based approaches in various settings where MDRcompromises anthracycline activity. The phase II trial reported atASH and the ongoing phase III trial of AS1413 have focused onpatients with secondary AML because this group represents asignificant unmet medical need, with a high prevalence of MDR andpoor outcome with standard, anthracycline-based regimens.The phase III ACCEDE trial compares AS1413-based andanthracycline-based regimens as remission-induction therapy forsecondary AML. It randomises 450 patients 1:1 to AS1413 pluscytarabine or daunorubicin plus cytarabine. Recruitment is proceedingrapidly, and data from the trial are expected in late 2010 or early2011.Bill Lundberg, MD, Project Leader for AS1413 at Antisoma, commented:"We're very pleased with the support from physicians and patientsaround the world for the ACCEDE study, which tests the idea ofreplacing the anthracycline daunorubicin with the novel DNAintercalator AS1413 as the partner for cytarabine inremission-induction treatment of secondary AML. We hope that thistrial will build on the positive findings from our phase II study andlead to the introduction of AS1413 as a new standard for thetreatment of secondary AML."Glyn Edwards, Antisoma's CEO, added: "AS1413 has distinctive featuresthat could translate into real benefits for patients. We lookforward to seeing the phase III data in secondary AML and believethat AS1413 could ultimately have potential in various blood cancersettings."An additional poster presentation given yesterday by Drs Ben Downieand James Foran of the University of Alabama at Birmingham consideredwhether certain karyotypes (different anomalies in the cancer cellchromosomes) were predictive of patients' outcomes in the phase IIstudy. A monosomal karyotype, which has recently been found topredict poor outcome in de novo AML patients, was found to have asimilar predictive value in the secondary AML patients studied in theAS1413 phase II trial.Copies of both posters are available on the Antisoma website athttp://www.antisoma.com/asm/products/as1413/Enquiries:Antisoma plc:Glyn Edwards, CEO +44 (0) 7909 915 068Daniel Elger, VP Marketing & CommunicationsMark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000Buchanan CommunicationsBrian Korb/Seth Lewis +1 646 378 2923The Trout GroupExcept 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 company'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.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 around 13,000new cases of AML diagnosed this year in the US alone. Antisomaestimates that 3,000-5,000 of these patients will have secondary AML(AML evolving from a myelodysplastic syndrome or followingchemotherapy or radiotherapy treatment for other cancers).About AS1413AS1413 (amonafide L-malate) was added to Antisoma's pipeline throughthe acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413is a novel DNA intercalator that induces apoptotic signalling byblocking topoisomerase II binding to DNA. This differs from theaction of classical topoisomerase II inhibitors, which induceapoptosis by causing extensive DNA damage. A further distinctivefeature of AS1413 is its ability to evade Pgp and relatedtransporters responsible for multi-drug resistance (MDR). A pivotalphase III trial is evaluating AS1413 as a treatment for secondaryAML, a condition often associated with MDR. This follows a phase IItrial in the same population, from which final data are reported hereand earlier data have been presented at conferences including the2008 ASCO and ASH meetings. Antisoma is developing AS1413independently and plans to commercialise the drug itself in the USwhile 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: 07.12.2009 - 08:01 Uhr
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