Sabuwar haɗin gwiwar gwaji na asibiti don maganin ciwon daji na prostate

Clarity Pharmaceuticals ta sanar da cewa gwajin da aka fara bincike (IIT) zai fara ba da jimawa ba a Amurka yana binciken 64Cu SAR-bisPSMA a cikin ciwon gurguwar prostate (NCT05286840)[1}.

Gwajin binciken X-Cancer na SAR-bisPSMA a cikin sananne ko ake zargi da cutar kansar prostate (X-Calibur) shine Mataki na I / II IIT a cikin marasa lafiya 150 har zuwa 64 a Cibiyar Ciwon daji na Urology da Cibiyar Nazarin GU (GURN) a Omaha, Nebraska, Dr Luke Nordquist ya dauki nauyin. Za ta binciki ɗimbin nau'ikan ciwon daji na prostate ta hanyar yin hoto tare da 64Cu-SAR-bisPSMA a ranar gudanarwa da kuma a wasu lokuta. Gwajin X-Calibur za ta yi la'akari da amincin XNUMXCu SAR-bisPSMA da kuma kallon tasirin samfurin akan tsarawa da kula da asibiti na mahalarta tare da ciwon gurguwar prostate.

Shugaban zartarwa na Clarity, Dokta Alan Taylor, yayi sharhi, "Muna farin cikin tallafawa gwajin Dr Nordquist, wanda ya sami kwarewa ta farko tare da samfuranmu a cikin gwajin 64Cu/67Cu SAR-bisPSMA SECuRE (NCT04868604)[2]. Muna sa ran ci gaba da yin aiki tare don ci gaba da haɓaka ingantaccen wakilinmu na SAR-bisPSMA a cikin ciwon gurguwar prostate da kuma bincika yawancin fa'idodin wannan samfur a matsayin wani ɓangare na shirin Clarity's Target Copper Theranostics (TCT) don cimma burinmu na ƙarshe na inganta jiyya. sakamako ga masu ciwon daji."

Ciwon daji na prostate shine mabuɗin mayar da hankali na Clarity's Targeted Copper Theranostics (TCT), inda IIT a GURN shine gwaji na huɗu na asibiti ta amfani da wakilin SAR-bisPSMA a cikin ciwon gurguwar prostate. Gwajin maganin 64Cu/67Cu SAR-bisPSMA na tushen Amurka, SECuRE (NCT04868604) [2], ya sami nasarar yin hoton marasa lafiya da ciwon gurguwar ƙwayar cuta daga sa'o'i 1 zuwa 72 bayan allura. Gwajin gwaji na 64Cu SAR-bisPSMA a Ostiraliya, PROPELLER (NCT04839367) [3], yana ci gaba sosai, tare da sama da 50% na mahalarta da aka ɗauka a cikin waɗanda ba a kula da su ba, an tabbatar da masu cutar kansar prostate (watau pre-radical prostatectomy). Gwajin gwaji na 64Cu SAR-bisPSMA na baya-bayan nan a cikin Amurka, COBRA (NCT05249127) [4], ya karɓi Wasiƙar Ci gaba na Nazarin daga FDA a cikin Fabrairu 2022, tare da ɗaukar mahalarta tare da maimaita biochemical na ciwon gurguwar prostate da aka shirya farawa a cikin kwata na biyu na 2022. Clarity ya riga ya sami shawara daga FDA cewa shirin likitancin prostate bincike tare da 64Cu SAR-bisPSMA yana magance yawan masu haƙuri guda biyu masu dacewa don rajista: pre-prostatectomy / pre-definitive treatment da marasa lafiya da ake zargi da sake dawowa biochemical. .