Clarity Pharmaceuticals, kampani yachipatala ya radiopharmaceutical yomwe ikupanga mankhwala am'badwo wotsatira kuti athe kuthana ndi zosowa zomwe zikukula mu oncology, yalengeza kuti yathandiza bwino omwe adatenga nawo gawo pagulu 2 la 64Cu/67Cu SARTATE ™ neuroblastoma therapy trial (CL04) pakuwonjezeka. mlingo wa 175MBq/kg kulemera kwa thupi.

Kuwunikira kwapita patsogolo posachedwa ku cohort 2 ya mayeso a CL04 atamaliza gulu la 1 pomwe otenga nawo mbali atatu adalandira chithandizo ndi 67Cu SARTATE ™ pamlingo wa 75MBq/kg kulemera kwa thupi. Komiti Yoyang'anira Chitetezo inayesa deta kuchokera ku gulu la 1 pomwe palibe mankhwala oletsa mlingo wa poizoni omwe anachitika ndipo analimbikitsa kuti apititse patsogolo mayesero a gulu la 2, popanda kusinthidwa, kuonjezera mlingo mpaka 175MBq/kg kulemera kwa thupi.

Wapampando wamkulu wa Clarity, Dr Alan Taylor, adati, "Ndife okondwa kupereka wodwala woyamba mu gulu 2 mu mayeso athu a neuroblastoma ku US, titamaliza bwino gulu 1 mu Januware 2022. Kuwonjezeka kwa ntchito zoyendetsedwa pakati pa gulu loyamba ndi 1 ndi yofunika kwambiri mu matenda okhudzidwa ndi ma radiation, monga neuroblastoma, ndipo gulu la 2 lidzawona ntchito zoyendetsedwa mopitirira kawiri poyerekeza ndi gulu la 2. Tikuyembekezera kupitiriza kulembera anthu mu gulu la 1 pa malo onse asanu azachipatala ku US, kumanga pa kulimbikitsa zidziwitso zoyambirira kuchokera ku gulu 2 ndikusonkhanitsanso umboni wazamankhwala ndi mapindu a mankhwala a SARTATE ™ pochiza ana omwe ali ndi neuroblastoma. "

Mayesero a CL04 ndi mayeso a theranostic (kuzindikira ndi kuchiza) kwa odwala omwe ali ndi chiopsezo chachikulu cha neuroblastoma (NCT04023331). Ndi malo ambiri, kukwera kwa mlingo, zolemba zotseguka, zosasankhidwa mwachisawawa, Gawo 1/2a mayesero azachipatala omwe ali ndi anthu okwana 34 omwe amachitidwa m'malo asanu azachipatala ku US.

Neuroblastoma nthawi zambiri imapezeka mwa ana osakwana zaka 5 ndipo imapezeka pamene chotupacho chikukula ndikuyambitsa zizindikiro. Ndi khansa yodziwika kwambiri yomwe imapezeka m'chaka choyamba cha moyo ndipo imachititsa pafupifupi 15% ya imfa za khansa ya ana. Neuroblastoma yoopsa kwambiri imatenga pafupifupi 45% ya milandu yonse ya neuroblastoma. Odwala omwe ali pachiwopsezo chachikulu cha neuroblastoma amakhala ndi zotsika kwambiri zazaka 5 zopulumuka pa 40% -50%.

Mu 2020, US Food and Drug Administration (FDA) idapatsa Clarity awiri Orphan Drug Designations (ODDs), imodzi ya 64Cu SARTATE™ ngati njira yodziwira matenda a neuroblastoma ndi imodzi ya 67Cu SARTATE ™ ngati chithandizo cha neuroblastoma, monga komanso awiri a Rare Pediatric Disease Designations (RPDDs) pazogulitsa izi. Ngati Kumveka Kungakhale Bwino Kukwaniritsa Ma Applications Atsopano Amankhwala a US FDA pazinthu ziwirizi, ma RPDD atha kulola Kampani kupeza ma Voucha Awiri Oyang'anira Zofunika Kwambiri (PRVs) omwe agulitsidwa posachedwapa ndi USD110M pa voucha iliyonse.

ZOMWE MUNGACHITE PA NKHANIYI:

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, kampani yachipatala ya radiopharmaceutical yomwe ikupanga mankhwala am'badwo wotsatira kuti athe kuthana ndi zosowa zomwe zikukula mu oncology, yalengeza kuti yathandiza bwino omwe adatenga nawo gawo pagulu 2 la 64Cu/67Cu SARTATE ™ neuroblastoma therapy trial (CL04) pakuwonjezeka. mlingo wa 175MBq/kg kulemera kwa thupi.