Isiguli sokuqala selashwe kusivivinyo se-cohort 2 SARTATE™ neuroblastoma therapy

I-Clarity Pharmaceuticals, inkampani ye-radiopharmaceutical yesiteji somtholampilo eyakha imikhiqizo yesizukulwane esilandelayo ukubhekana nezidingo ezikhulayo ku-oncology, imemezele ukuthi ilaphe ngempumelelo umhlanganyeli wayo wokuqala ku-cohort 2 ye-64Cu/67Cu SARTATE™ neuroblastoma therapy trial (CL04) ekwenyukeni kocwaningo. izinga lomthamo we-175MBq/kg isisindo somzimba.              

I-Clarity isanda kuthuthukela ku-cohort 2 yohlolo lwe-CL04 kulandela ukuqedwa kweqembu 1 lapho ababambiqhaza abathathu bathola ukwelashwa nge-67Cu SARTATE™ ngethamo lika-75MBq/kg isisindo somzimba. IKomidi Lokubuyekeza Ukuphepha lihlole idatha evela kuqembu 1 lapho kungekho ubuthi obukhawula umthamo obenzekile futhi lancoma ukuthi kuqhutshekwe nesivivinyo kuqoqo 2, ngaphandle kokuguqulwa, kukhushulwe umthamo ukuya ku-175MBq/kg isisindo somzimba.

USihlalo Ophethe we-Clarity, uDkt Alan Taylor, uphawule wathi, “Sijabule kakhulu ukunikeza isiguli sokuqala eqenjini lesi-2 ocwaningweni lwethu lwe-neuroblastoma therapy e-US, njengoba siqede ngempumelelo i-cohort 1 ngoJanuwari 2022. Ukwanda komsebenzi olawulwayo phakathi kweqembu 1 kanye I-2 ibalulekile esifweni esingazweli emisebeni, njenge-neuroblastoma, futhi iqoqo lesi-2 lizobona imisebenzi eqondiswayo engaphezu kokuphindwe kabili uma kuqhathaniswa neqembu 1. Sibheke phambili ekuqhubekeni nokuqashwa kweqembu lesi-2 kuzo zonke izizinda ezinhlanu zomtholampilo e-US, sakhela phezu kwe- ekhuthaza idatha yokuqala evela eqenjini 1 kanye nobunye ubufakazi obuqoqwe bezinzuzo zokuxilonga nezokwelashwa zomkhiqizo we-SARTATE™ wokwelapha izingane ezine-neuroblastoma.”

Uhlolo lwe-CL04 luyisivivinyo se-theranostic (ukuxilongwa kanye nokwelashwa) ezigulini zezingane ezine-neuroblastoma enobungozi obukhulu (NCT04023331). Iwukuhlolwa kwezikhungo eziningi, ukukhuphuka komthamo, ilebula evulekile, okungahleliwe, Isigaba 1/2a socwaningo lomtholampilo olunababambiqhaza abangafika kwabangu-34 olwenziwa ezindaweni ezinhlanu zomtholampilo e-US.

I-Neuroblastoma ivamise ukuvela ezinganeni ezingaphansi kweminyaka engu-5 ubudala futhi yethula lapho isimila sikhula futhi sibangele izimpawu. Iwuhlobo lomdlavuza oluvame ukutholakala onyakeni wokuqala wokuphila futhi lubangela cishe u-15% wokufa komdlavuza wezingane. I-neuroblastoma enobungozi obukhulu ibalelwa ku-45% wazo zonke izimo ze-neuroblastoma. Iziguli ezine-neuroblastoma esengozini enkulu zinezinga eliphansi kakhulu lokusinda leminyaka emi-5 ku-40% -50%.

Ngo-2020, i-US Food and Drug Administration (FDA) yaklomelisa nge-Clarity two Orphan Drug Designations (ODDs), eyodwa yama-64Cu SARTATE™ njenge-ejenti yokuxilonga yokuphathwa komtholampilo kwe-neuroblastoma kanye ne-67Cu SARTATE™ njengendlela yokwelapha i-neuroblastoma, njengoba kanye nama-Rare Pediatric Disease Designations (RPDD) amabili ale mikhiqizo. Uma Ukucaca kuphumelele ekufinyeleleni Izicelo Zezidakamizwa Ezintsha ze-US FDA zale mikhiqizo yomibili, ama-RPDD angase avumele Inkampani ukuthi ifinyelele isamba samaVousha Okubukeza Okubalulekile Okubili (ama-PRV) athengisekayo asanda kuhweba ngo-USD110M ngevawusha ngayinye.