ʻO ka mea maʻi mua i mālama ʻia i ka cohort 2 SARTATE™ neuroblastoma therapy hoʻāʻo

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Ua hoʻolaha ʻo Clarity Pharmaceuticals, kahi hui radiopharmaceutical clinical-stage e hoʻomohala ana i nā huahana e hiki mai ana e hoʻoponopono i nā pono e ulu ana i ka oncology, ua hoʻolaha maikaʻi ʻo ia i kāna mea komo mua i ka cohort 2 o ka 64Cu/67Cu SARTATE™ neuroblastoma therapy hoʻāʻo (CL04) i ka hoʻonui ʻia. pae kiʻekiʻe o 175MBq/kg paona kino.              

Ua holomua nei ʻo Clarity i ka cohort 2 o ka hoʻāʻo CL04 ma hope o ka pau ʻana o ka cohort 1 kahi i loaʻa ai i ʻekolu mau mea i ka lāʻau lapaʻau me 67Cu SARTATE ™ ma kahi maʻa o 75MBq/kg paona kino. Ua loiloi ke Kōmike Hōʻike Palekana i ka ʻikepili mai ka cohort 1 kahi i loaʻa ʻole ai ka palena palena i nā mea ʻawaʻawa a ʻōlelo ʻia e holomua i ka hoʻokolokolo i ka cohort 2, me ka ʻole o ka hoʻololi ʻana, e hoʻonui ana i ka nui i 175MBq / kg paona kino.

Ua ʻōlelo ka Luna Hoʻokele o Clarity, ʻo Dr Alan Taylor, "Ua hauʻoli nui mākou i ka hoʻopaʻa ʻana i ka mea maʻi mua ma ka cohort 2 i kā mākou hoʻokolohua neuroblastoma therapy ma US, me ka hoʻopau ʻana i ka cohort 1 i Ianuali 2022. He mea koʻikoʻi ka 1 i ka maʻi radiation-sensitive, e like me neuroblastoma, a ʻo ka cohort 2 e ʻike i nā hana lawelawe ʻoi aku ma mua o ka pālua i ka hoʻohālikelike ʻia me ka cohort 2. Ke kali nei mākou i ka hoʻomau ʻana i ka hoʻomaʻamaʻa ʻana i ka cohort 1 ma nā kahua lapaʻau ʻelima ma US, e kūkulu ana ma luna o ka ka paipai ʻana i ka ʻikepili mua mai ka cohort 2 a me ka hōʻiliʻili hou ʻana i nā hōʻike o nā pono diagnostic a me ka therapeutic o ka huahana SARTATE ™ no ka mālama ʻana i nā keiki me ka neuroblastoma.

ʻO ka ho'āʻo CL04 he hoʻokolohua theranostic (diagnosis and therapy) i nā maʻi pediatric me ka neuroblastoma kiʻekiʻe (NCT04023331). He multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a hoʻokolohua lapaʻau me 34 mau mea komo i mālama ʻia ma ʻelima mau kahua lapaʻau ma US.

Loaʻa pinepine ʻia ka neuroblastoma i nā keiki ʻoi aku ma mua o 5 mau makahiki a loaʻa i ka wā e ulu ai ka maʻi ʻaʻai a hōʻike i nā hōʻailona. ʻO ia ke ʻano maʻi maʻi maʻamau e ʻike ʻia i ka makahiki mua o ke ola a ma kahi o 15% o ka maʻi maʻi maʻi pediatric. Loaʻa ka neuroblastoma kiʻekiʻe ma kahi o 45% o nā hihia neuroblastoma āpau. ʻO ka poʻe maʻi me ka neuroblastoma kiʻekiʻe loa ka haʻahaʻa haʻahaʻa haʻahaʻa o 5 mau makahiki ola ma 40% -50%.

I ka makahiki 2020, ua hāʻawi ka US Food and Drug Administration (FDA) iā Clarity i ʻelua Orphan Drug Designations (ODDs), hoʻokahi no 64Cu SARTATE ™ ma ke ʻano he mea diagnostic no ka hoʻokele lapaʻau o neuroblastoma a hoʻokahi no 67Cu SARTATE ™ ma ke ʻano he lapaʻau o neuroblastoma, e like me a me ʻelua Rare Pediatric Disease Designations (RPDDs) no kēia mau huahana. Inā kūleʻa ʻo Clarity i ka loaʻa ʻana o US FDA New Drug Applications no kēia mau huahana ʻelua, hiki i nā RPDDs ke ʻae i ka Hui e komo i ka huina o ʻelua Priority Review Voucher (PRVs) i kūʻai hou ʻia ma USD110M no kēlā me kēia voucher.

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