Onconova公司的抗癌药物rigosertib被设计用于治疗骨髓增生异常综合征

2015年2月4日讯/生物谷BIOON/--制药巨头百特公司最近表示将取消其对Onconova公司抗癌药物rigosertib欧洲临床研究的支持。这也意味着两家公司此前达成的价值5亿6千5百万美元的协议宣告打水漂。
Onconova公司的抗癌药物rigosertib被设计用于治疗骨髓增生异常综合征，这种骨髓异常紊乱疾病是一种常见的肿瘤药物治疗并发症。百特于2012年和Onconova公司签订协议，同意预付5千万美元外加高达5亿1千5百万美元的里程碑奖金交换rigosertib的欧洲市场版权。然而，两年过去了，经过一系列临床研究的失败，百特公司最终丧失耐性，决定放弃开展关于rigosertib的新研究以及申报rigosertib治疗低风险骨髓增生异常综合征的方案。
不过，Onconova公司透露，百特公司并不是彻底放弃了rigosertib。双方在rigosertib治疗高风险骨髓增生异常综合征和胰腺癌方面仍将保持密切合作。不过，去年Onconova公司在美国的一项关于治疗高风险骨髓增生异常综合征的临床研究中未能与对照组表现出显着性差异，使得投资者对rigosertib的预期再度走低不少。新年伊始，百特公司的这一决定对Onconova可谓是雪上加霜。
目前临床治疗肿瘤的各种疗法总存在着这样或那样的副作用或并发症。而骨髓增生异常综合征则是其中很常见的一种。然而，无论是美国市场还是欧洲市场，目前都缺少能够有效处理这种并发症的药物。Onconova公司CEORameshKumar今天表示公司将一如既往的致力于推动rigosertib的研发。不过，再获得FDA和欧洲医药管理部门点头同意之前，Onconova公司首先要解决的是从哪里找到一个新的合作伙伴来分担研发费用。
详细英文报道：
Baxter($BAX)isscalingbackitssupportofOnconovas($ONTX)leadcandidate,nixingplanstopayforEuropeantrialsandparingdownthepotentialofwhatcouldhavebeena$565milliondealforthebiotech.
Thedrug,rigosertib,isdesignedtotreatmyelodysplasticsyndrome,ararebonemarrowdisorderthatoftendevelopsaftercancertreatment.Baxterboughtintotheprogramin2012,paying$50millionupfrontandpromisingupto$515millionmoreinexchangefortheEuropeanrightstothedrug.However,afteraseriesofclinicalsetbacks,Baxterisnowcallingoffitsplansfornewstudiesandaneventualregulatorysubmissionforrigosertibinlow-riskMDS,newsthatsentOnconovassharesdownabout35%.
WhileBaxtersdecisionmakesOnconovaineligibleforsomeundisclosedmilestonepayments,themovedoesntaffectthepairsEuropeancollaborationonrigosertibinhigh-riskformsofMDSorinpancreaticcancer,thebiotechsaid.
Meanwhile,intheU.S.,Onconovaisworkingtopickupthepiecesofaclinicaltrialfailurethathasseverelydampenedrigosertibsprospects.
Lastyear,thedrugfailedtoachieveastatisticallysignificantimprovementinoverallsurvivalcomparedtostandardcareinhigh-riskMDS,butOnconovaisplanningtolaunchanotherPhaseIIItrialtargetingthesubgroupofpatientsthatrespondedwelltotheintravenoustreatment,anglingtomakerigosertibasecond-linetherapyforthosewhofailonhypomethylatingagents.
"TherehavebeennodrugapprovalsintheU.S.since2005toaddresstheunmetmedicalneedofthesepatients,"CEORameshKumarsaidinastatement."WeremaincommittedtodevelopingrigosertibIVtomeettheneedsofthisunderservedpatientpopulation."
First,OnconovawillneedtheblessingoftheFDAandtheEuropeanMedicinesAgencytogetanotherpivotaltrialrolling,andthecompanywouldhavetosecurewhatitcalls"appropriatefinancing"topayfortheeffort.
LeerinkanalystHowardLiang,forone,islessthanoptimisticaboutOnconovasodds,pointingoutinaninvestornotethat"whilethereappearstobeasignalincertainsubgroupsofthepreviousPhaseIIIstudyin(high-riskMDS)setting,wearegenerallynotabigfanofrelyingonsubgroupanalyses,especiallyinapossiblescenariothattheoutlookoftheentirecompanycouldbedependentonsuchananalysis."

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