Clarity Pharmaceuticals, perusahaan radiopharmaceutical tahap klinis sing ngembangake produk generasi sabanjure kanggo ngatasi kebutuhan onkologi sing saya tambah akeh, ngumumake yen wis sukses nambani peserta pisanan ing kelompok 2 saka uji coba terapi neuroblastoma 64Cu/67Cu SARTATE™ (CL04) kanthi tambah. tingkat dosis 175MBq/kg bobot awak.

Clarity bubar maju menyang kohort 2 saka uji coba CL04 sawise rampung kohort 1 ing ngendi telung peserta nampa terapi karo 67Cu SARTATE ™ kanthi dosis 75MBq / kg bobot awak. Komite Review Safety ngevaluasi data saka kohort 1 ing ngendi ora ana keracunan sing mbatesi dosis lan dianjurake kanggo nerusake uji coba menyang kohort 2, tanpa modifikasi, nambah dosis dadi 175MBq / kg bobot awak.

Ketua Eksekutif Clarity, Dr Alan Taylor, menehi komentar, "Kita bungah banget kanggo dosis pasien pertama ing kohort 2 ing uji coba terapi neuroblastoma ing AS, sawise kasil ngrampungake kohort 1 ing Januari 2022. Tambah ing kegiatan administrasi antarane kohort 1 lan 2 pinunjul ing penyakit sing sensitif radiasi, kayata neuroblastoma, lan kohort 2 bakal ndeleng aktivitas sing ditindakake luwih saka kaping pindho dibandhingake karo kohort 1. nyengkuyung data awal saka kohort 2 lan luwih akeh ngumpulake bukti keuntungan diagnostik lan terapeutik saka produk SARTATE ™ kanggo perawatan bocah-bocah kanthi neuroblastoma.

Uji coba CL04 minangka uji coba theranostic (diagnosis lan terapi) ing pasien pediatrik kanthi neuroblastoma berisiko tinggi (NCT04023331). Iki minangka uji klinis multi-pusat, eskalasi dosis, label terbuka, non-acak, Fase 1/2a kanthi nganti 34 peserta sing ditindakake ing limang situs klinis ing AS.

Neuroblastoma paling asring dumadi ing bocah-bocah sing umure luwih enom saka 5 taun lan muncul nalika tumor tuwuh lan nyebabake gejala. Iki minangka jinis kanker sing paling umum sing didiagnosa ing taun pisanan urip lan kira-kira 15% saka kematian kanker pediatrik. Neuroblastoma beresiko dhuwur kira-kira 45% saka kabeh kasus neuroblastoma. Pasien karo neuroblastoma beresiko dhuwur duwe tingkat kaslametan 5 taun paling murah ing 40% -50%.

Ing 2020, US Food and Drug Administration (FDA) menehi Clarity loro Orphan Drug Designations (ODDs), siji kanggo 64Cu SARTATE™ minangka agen diagnostik kanggo manajemen klinis neuroblastoma lan siji kanggo 67Cu SARTATE™ minangka terapi neuroblastoma, minangka uga loro Rare Pediatric Disease Designations (RPDDs) kanggo produk kasebut. Yen Clarity sukses nggayuh Aplikasi Obat Anyar FDA AS kanggo rong produk kasebut, RPDD bisa uga ngidini Perusahaan ngakses total rong Voucher Prioritas Review (PRV) sing bisa didagang sing paling anyar didagang ing USD110M saben voucer.

APA sing kudu dijupuk saka ARTIKEL INI:

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.
Clarity Pharmaceuticals, perusahaan radiopharmaceutical tahap klinis sing ngembangake produk generasi sabanjure kanggo ngatasi kebutuhan onkologi sing saya tambah akeh, ngumumake yen wis sukses nambani peserta pisanan ing kelompok 2 saka uji coba terapi neuroblastoma 64Cu/67Cu SARTATE™ (CL04) kanthi tambah. tingkat dosis 175MBq/kg bobot awak.