I-Clarity Pharmaceuticals, inkampani ye-radiopharmaceutical yenqanaba leklinikhi ephuhlisa iimveliso zesizukulwana esilandelayo ukujongana neemfuno ezikhulayo kwi-oncology, yabhengeza ukuba iye yaphatha ngempumelelo umthathi-nxaxheba wayo wokuqala kwi-2 ye-64Cu/67Cu SARTATE ™ neuroblastoma therapy trial (CL04) ekwandisweni kovavanyo. inqanaba lethamo le-175MBq/kg ubunzima bomzimba.
Ukucaca kutshanje kuye kwaqhubela phambili kwi-cohort ye-2 yolingo lwe-CL04 emva kokugqitywa kweqela le-1 apho abathathi-nxaxheba abathathu bafumana unyango nge-67Cu SARTATE™ kwi-dose ye-75MBq / kg ubunzima bomzimba. IKomiti yoPhononongo loKhuseleko ivavanye idatha evela kwiqela le-1 apho kungekho dosi yokunciphisa i-toxicity eyenzekileyo kwaye inconywa ukuba iqhubele phambili uvavanyo kwi-cohort 2, ngaphandle kokuguqulwa, ukwandisa umthamo ukuya kwi-175MBq / kg ubunzima bomzimba.
USihlalo oLawulayo weClarity, uGqr Alan Taylor, uthe, “Siyavuya kakhulu ukunika ithamo isigulana sokuqala kwiqela lesi-2 kulingo lwethu lonyango lwe-neuroblastoma e-US, sigqibe ngempumelelo iqela loku-1 ngoJanuwari 2022. Ukonyuka komsebenzi olawulwayo phakathi kweqela loku-1 kunye I-2 ibalulekile kwi-radiation-sensitive disease, njenge-neuroblastoma, kunye ne-2 cohort iya kubona imisebenzi elawulwayo ngaphezu kokuphindwe kabini xa kuthelekiswa neqela le-1. Sijonge phambili ekuqhubeni ukuqashwa kwi-cohort 2 kuzo zonke iisayithi ezintlanu zekliniki e-US, ukwakha phezu ukukhuthaza idatha yokuqala evela kwiqela loku-1 kunye nokuqokelela ngakumbi ubungqina boxilongo kunye nezibonelelo zonyango zemveliso ye-SARTATE ™ yonyango lwabantwana abane-neuroblastoma. "
Ulingo lwe-CL04 luvavanyo lwe-theranostic (ukuxilongwa kunye nonyango) kwizigulane zabantwana ezine-neuroblastoma ephezulu (NCT04023331). Ngamaziko amaninzi, ukunyuswa kwedosi, ileyibhile evulekileyo, i-non-randomised, iSigaba 1/2a solingo lwezonyango olunabathathi-nxaxheba abaya kuthi ga kwi-34 abaqhutywe kwiindawo ezintlanu zekliniki e-US.
I-Neuroblastoma idla ngokuvela kubantwana abangaphantsi kweminyaka emi-5 ubudala kwaye ibonisa xa i-tumor ikhula kwaye ibangele iimpawu. Lolona hlobo luqhelekileyo lomhlaza olufunyaniswayo kunyaka wokuqala wobomi kwaye lubalelwa kwi-15% yokusweleka komhlaza wabantwana. Umngcipheko ophezulu we-neuroblastoma ubalelwa malunga ne-45% yazo zonke iimeko ze-neuroblastoma. Izigulane ezinomngcipheko ophezulu we-neuroblastoma zinezinga eliphantsi le-5 leminyaka yokuphila kwi-40% -50%.
Ngo-2020, i-US Food and Drug Administration (FDA) yanika i-Clarity ezimbini zokutyunjwa kweziyobisi zeNkedama (ODDs), enye ye-64Cu SARTATE™ njenge-arhente yoxilongo kulawulo lwezonyango lwe-neuroblastoma kunye ne-67Cu SARTATE™ njengonyango lwe-neuroblastoma, njengoko kunye neZifo ezimbini eziNxibelekayo zaBantwana (RPDDs) kwezi mveliso. Ukuba Ingcaciso iphumelele ekufezekiseni i-US FDA iziCelo eziTsha zeChiza kwezi mveliso zimbini, ii-RPDDs zinokuvumela iNkampani ukuba ifikelele kwiiVawutsha ezimbini ezithengiswayo eziPhambili eziPhambili (PRVs) ezithe zathengiswa kutshanje nge-USD110M ngevawutsha nganye.
INTO ONOKUYITHATHA KWELI NQAKU:
- We look forward to continuing recruitment in cohort 2 at all five clinical sites in the US, building upon the encouraging initial data from cohort 1 and further gathering evidence of diagnostic and therapeutic benefits of the SARTATE™ product for the treatment of children with neuroblastoma.
- In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE™ as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE™ as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products.
- I-Clarity Pharmaceuticals, inkampani ye-radiopharmaceutical yenqanaba leklinikhi ephuhlisa iimveliso zesizukulwana esilandelayo ukujongana neemfuno ezikhulayo kwi-oncology, yabhengeza ukuba iye yaphatha ngempumelelo umthathi-nxaxheba wayo wokuqala kwi-2 ye-64Cu/67Cu SARTATE ™ neuroblastoma therapy trial (CL04) ekwandisweni kovavanyo. inqanaba lethamo le-175MBq/kg ubunzima bomzimba.
