Antisoma AGM update and Interim Management Statement
(Thomson Reuters ONE) - London, UK, and Cambridge, MA: 10 November 2009 - Antisoma plc (LSE:ASM; USOTC: ATSMY) holds its AGM today and provides an update, whichalso serves as the Company's Interim Management Statement for theperiod from 1 July 2009 to 9 November 2009.Antisoma's CEO Glyn Edwards, said: "We are finishing 2009 in a strongposition, with two drugs well into pivotal phase III trials andsignificant cash resources. We are focused on completing key studiesof our late-stage drugs and preparing for their commercialisation,while also continuing to explore opportunities to add new assets toour business."ASA404 - a potential blockbusterASA404, our Tumour-Vascular Disrupting Agent, continues to make goodprogress in the capable hands of our partner, Novartis. In September,we announced that the ATTRACT-1 phase III trial had completed patientenrolment. This 1200-patient study is evaluating ASA404 incombination with standard chemotherapy as a first-line treatment fornon-small cell lung cancer. We expect data from the trial in late2010 or early 2011, with applications for marketing to follow during2011 if the data are positive.Novartis is also conducting ATTRACT-2, a 900-patient phase III trialtesting ASA404 as a second-line treatment for non-small cell lungcancer. Testing the drug in both the first- and second-line settingswill ensure that a broad spectrum of lung cancer patients could beeligible for treatment with the drug.Novartis also intends to develop ASA404 in another major indication,HER2-negative metastatic breast cancer. More details of the plans forthis indication will be available in the near future.Antisoma has the option to co-commercialise ASA404 with Novartis inthe US, which fits with Antisoma's plans to become directly involvedin the commercialisation of its products. The deal with Novartiscould yield substantial milestone payments based on the progress ofASA404 as well as royalties on all sales of the drug worldwide.AS1413 - second key phase III productAS1413 is a novel chemotherapy drug with promising potential as atreatment for blood cancers. A key property of AS1413 is its abilityto evade a variety of multi-drug resistance mechanisms, such as Pgp,MRP-1 and BCRP. These are molecular pumps used by cancer cells toexpel drugs, including some of the major chemotherapies in use today.By evading these mechanisms, AS1413 has the potential to work insettings where other treatments provide limited benefit.We are developing AS1413 initially as a treatment for secondary acutemyeloid leukaemia (secondary AML), a form of AML that evolves fromprior bone marrow disease or develops following radiotherapy orchemotherapy for other cancers. Patients with secondary AML oftenhave multi-drug resistant disease and there are no drugs approvedspecifically for this condition.We are enrolling patients into a pivotal, randomised phase III trialof AS1413 in secondary AML. This trial, called ACCEDE, comparesAS1413 plus cytarabine with daunorubicin plus cytarabine, the mostcommon initial treatment for AML. The ACCEDE study builds on positivedata from previous studies: from a phase I trial, just published inLeukemia Research, which highlighted the drug's potential in thissetting, and from a phase II trial that evaluated the drug in 88patients with secondary AML. Final follow-up data from the phase IItrial will be presented at this year's ASH meeting in December.Results from the ACCEDE trial are expected to be available in late2010 or early 2011. Should these be positive, we plan to market thedrug ourselves in the US while seeking partners for marketing inother territories. We believe that AS1413 could achieve worldwidesales running into hundreds of millions of dollars as a treatment forsecondary AML, and that there is also a wider opportunity for thedrug in other blood cancer settings.AS1411 - significant developments aheadEarlier this year we presented positive data from a phase II trial ofour aptamer drug, AS1411, in AML. The addition of 10 or 40 mg/kg/dayAS1411 to cytarabine chemotherapy increased the response rate withoutsignificantly increasing side-effects. We now plan to build on thesefindings by conducting a phase IIb trial, which is expected to beginearly next year.The new trial will include around 90 patients in three treatmentgroups: a control group will get chemotherapy alone while twocombination groups receive AS1411 together with chemotherapy. AS1411will be given at 40 or 80 mg/kg/day, so the highest dose tested willbe twice that used in the previous trial. The dose of cytarabinechemotherapy will also be slightly higher than that used previously.In addition, the patient population will be refined: the prior trialincluded patients who had proved unresponsive (refractory) toprevious therapy or who had suffered up to three relapses, whereasthe new trial will only include patients in first relapse orrefractory to one previous treatment. The phase IIb trial willcapture the initial response to treatment, how long patients remaindisease-free and how long they survive following treatment. The goalis to provide a data-set that allows us to make optimal plans for aregistration study.In parallel with the programme in AML, we have been running asingle-arm phase II trial in renal cancer. This completed patientenrolment in May, and is expected to report initial data before theend of 2009.As with AS1413, Antisoma currently retains all marketing andcommercialisation rights to AS1411. We plan to continue developmentthrough late-stage trials and to commercialise the product ourselvesin the US while seeking partners for other territories.Strong financial positionWe reported in our year-end financial results that we had GBP 67.0million at the end of June 2009, and indicated that these funds weresufficient to support all our priority programmes until mid-2011,beyond the time when data are expected from the key phase III studiesof ASA404 and AS1413.OutlookBefore the end of this year, we expect the first data from our phaseII trial of AS1411 in renal cancer and additional details ofNovartis' plans for developing ASA404 in breast cancer. We are movingforward with our plans to transition from a company focused ondeveloping cancer drugs into one that can also successfullycommercialise them. While our principal focus is the completion ofphase III trials on ASA404 and AS1413, we also continue to advancethe earlier stage products in our portfolio and to exploreopportunities to add new drugs to the pipeline.Enquiries:Antisoma plc +44 (0)203 249 2100/ + 44 (0) 7909 915068Glyn Edwards, Chief Executive OfficerDaniel Elger, VP, Marketing &CommunicationsAlison Saville, Senior Marketing &Communications ExecutiveBuchanan Communications +44 (0)20 7466 5000(All media enquiries)Mark Court, Lisa Baderoon, Catherine BreenThe 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.Background on 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 visit www.antisoma.comfor 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: 10.11.2009 - 08:01 Uhr
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