和黃中國在美國啟動呋喹替尼（Fruquintinib）一期臨床試驗
關(guān)鍵詞：
和黃中國醫(yī)藥科技有限公司在美國啟動了呋喹替尼(Fruquintinib)一期臨床試驗。呋喹替尼是一種高選擇性強效口服血管內(nèi)皮生長因子受體(VEGFR)1,2及3的抑制劑,已經(jīng)在中國進行了一些II期和III期臨床試驗,用于治療結(jié)直腸癌、肺癌和胃癌,試驗達(dá)到主要終點。美國的臨床研究是一項多中心、開放性I期臨床研究,用于評估呋喹替尼在美國晚期實體瘤患者中的安全性、耐受性和藥代動力學(xué)。本月早些時候已開始第一個劑量的給藥。關(guān)于這項研究的其他細(xì)節(jié)可以在clinicaltrials.gov上找到,代號NCT03251378。
歡迎欣賞新聞稿！Chi-MedInitiatesFruquintinibU.S.ClinicalTrials
December15,201702:00AMEasternStandardTime
LONDON--(BUSINESSWIRE)--HutchisonChinaMediTechLimited(“Chi-Med”)(AIM/Nasdaq:HCM)hasinitiatedtheUnitedStatesPhaseIbridgingclinicaltrialoffruquintinib.Fruquintinibisahighlyselectiveandpotentoralinhibitorofvascularendothelialgrowthfactorreceptors(“VEGFR”)1,2and3,thathasmetitsprimaryendpointinseveralPhaseIIandIIIclinicaltrialsinChinaforthetreatmentofcolorectal,lungandgastriccancers.TheclinicalstudyintheU.S.isamulti-center,open-label,PhaseIclinicalstudytoevaluatethesafety,tolerabilityandpharmacokineticsoffruquintinibinU.S.patientswithadvancedsolidtumors.Thefirstdrugdosewasadministeredearlierthismonth.Additionaldetailsaboutthisstudymaybefoundatclinicaltrials.gov,usingidentifierNCT03251378.
AboutFruquintinibDevelopmentinChina
Colorectalcancer:TheChinaFoodandDrugAdministration(“CFDA”)acknowledgedacceptanceoftheNewDrugApplication(“NDA”)forfruquintinibforthetreatmentofpatientswithadvancedcolorectalcancer(“CRC”)inJune2017.Fruquintinibwassubsequentlyawardedpriorityreviewstatusinviewofitssignificantclinicalvalue,accordingtoaCFDAannouncementinSeptember2017.TheNDAissupportedbydatafromthesuccessfulFRESCOstudy,aPhaseIIIpivotalregistrationtrialoffruquintinibin416patientswithCRCinChina,whichwashighlightedinanoralpresentationattheAmericanSocietyofClinicalOncologyAnnualMeetingheldonJune5,2017(clinicaltrials.govidentifierNCT02314819).TheFRESCOstudyfollowedaninitialPhaseItrialin40solidtumorpatients,aPhaseIbstudyin62CRCpatients,andaPhaseIIclinicaltrialin71CRCpatients.
Lungcancer:FruquintinibisbeingstudiedinaPhaseIIIpivotaltrialinapproximately520third-linenon-smallcelllungcancer(“NSCLC”)patients,knownastheFALUCAstudy(clinicaltrials.govidentifierNCT02691299),followingaPhaseIIclinicaltrialin91third-lineNSCLCpatients.FruquintinibisconcurrentlybeingstudiedinaPhaseIIstudyincombinationwithIressa®(gefitinib)infirst-linesettingforpatientswithadvancedormetastaticNSCLC(clinicaltrials.govidentifierNCT02976116).
Gastriccancer:InOctober2017,Chi-MedinitiatedapivotalPhaseIIIclinicaltrialoffruquintinibincombinationwithTaxol®(paclitaxel),knownastheFRUTIGAstudy,forthetreatmentofover500patientswithadvancedgastricorgastroesophagealjunction(GEJ)adenocarcinoma(clinicaltrials.govidentifierNCT03223376).
InChina,fruquintinibisjointlydevelopedwithEliLillyandCompany.
AboutFruquintinib
Fruquintinib(HMPL-013)isahighlyselectivesmallmoleculedrugcandidatethathasbeenshowntoinhibitVEGFR24hoursadayviaanoraldose,withloweroff-targettoxicitiescomparedtoothertargetedtherapies.Itstolerability,alongwithitscleandrug-druginteractionprofiledemonstratedtodate,mayenablerationalcombinationwithothercancertherapiessuchaschemotherapyandothertargetedtherapies,whicharebeingstudiedinourongoingclinicaltrialsoffruquintinib.
Atanadvancedstage,tumorssecretelargeamountsofvascularendothelialgrowthfactor(“VEGF”),aproteinligand,tostimulateformationofexcessivevasculature(angiogenesis)aroundthetumortoprovidegreaterbloodflow,oxygen,andnutrientstothetumor.VEGFandVEGFRplaypivotalrolesintumor-relatedangiogenesis,andfruquintinibinhibitstheVEGF/VEGFRpathway.Thisrepresentsanimportanttherapeuticstrategyinblockingthedevelopmentofnewbloodvesselsessentialfortumorstogrowandinvade.
AboutChi-Med
Chi-Medisaninnovativebiopharmaceuticalcompanywhichresearches,develops,manufacturesandsellspharmaceuticalsandhealthcareproducts.ItsInnovationPlatform,HutchisonMediPharmaLimited,focusesondiscoveringanddevelopinginnovativetherapeuticsinoncologyandautoimmunediseasesfortheglobalmarket.ItsCommercialPlatformmanufactures,markets,anddistributesprescriptiondrugsandconsumerhealthproductsinChina.