Ua hoʻolaha ʻo Isofol Medical AB i kēia lā i ka hoʻomaka ʻana o ka ʻikepili ʻikepili o ka multi-center, global Phase III AGENT Study e noiʻi ana i ka arfolitixorin i hui pū ʻia me 5-FU, oxaliplatin a me bevacizumab i ka holomua, metastatic colorectal cancer (mCRC). ʻO ka hoʻomaka ʻana o ke kaʻina heluhelu ʻana ma hope o nā kūkākūkā me ka US Food and Drug Administration (FDA) e pili ana i nā lula censoring a me ka helu o nā hanana PFS i koi ʻia e hoʻomaka i ka hōʻiliʻili ʻikepili a me ka nānā ʻana. E hoʻoholo ʻo Isofol i ka helu o nā hanana PFS no ka ʻoki ʻana, a laila e noʻonoʻo ʻia e ka FDA i ka wā o ka loiloi NDA.
ʻO ka loiloi ikaika o nā koho no kahi SAP i hoʻoponopono hou ʻia i alakaʻi i nā noʻonoʻo hou no ka nānā ʻana i ka ʻikepili. E hoʻouna ʻo Isofol i nā loiloi o ke aʻo ʻana e pili ana i nā maʻi 490 i kākau inoa ʻia i loko o ke aʻo ʻana (nā maʻi Iapana i hoʻohui ʻia ma mua i hoʻohui ʻia i ka noiʻi nui) a e hoʻokomo ʻia nā lula censoring kumu a me nā mea hou i loko o ka New Drug Application (NDA). Ke hoʻomau nei ka kūpaʻa o ka AGENT Study. Hoʻopili paʻa ʻia ʻo Isofol i kahi loiloi piha a manaʻo ʻia ʻelua a ʻehā mau mahina mai ka hoʻomaka ʻana o ka loiloi ma mua o ka hiki ke haʻi ʻia nā hopena kiʻekiʻe.
ʻO ka maʻi maʻi colorectal ke kolu o ke kumu nui o ka maʻi kanesa ma ka honua a ʻo ka lua o ke kumu nui o ka make maʻi kanesa me ka aneane hoʻokahi miliona mau make ma 2020. nā papa hana chemotherapy no nā hopena koʻikoʻi i ka wā o ka mālama ʻana. 'O ia ho'i, aneane loa'a i nā po'e ma'i mua o ka mCRC ka folate i loa'a ka regimen ma ke 'ano o ka mālama ma'amau.
"Aia kahi hemahema nui ʻole i ka maʻi kanesa colorectal metastatic, akā ke aʻo ʻia nei nā lāʻau lapaʻau e pono ai ka hapa nui o nā maʻi me nā pahuhopu kikoʻī," wahi a Ulf Jungnelius, Luna Nui o Isofol. "Ma Isofol, ua hoʻokaʻawale mākou i ka ʻike ʻana i kahi maʻalahi a ʻoi aku ka maikaʻi o ka hoʻoponopono ʻana i ka maʻamau o ka mālama ʻana e hōʻemi i ke kaumaha o ka maʻi maʻi a hoʻonui i ke ola o nā mea maʻi."
No nā makahiki he 40 i hala iho nei, ua lawelawe ʻia ʻo 5-FU i ʻoi aku ma mua o 70 ka nui o nā maʻi me ka mCRC i hui pū me ka leucovorin/levoleucovorin a me nā cytostatics ʻē aʻe. ʻOiai ʻo kēia mau hui pū ʻana, hiki i kahi hapa liʻiliʻi o nā mea maʻi ke koho ʻia no ka ʻoki ʻana (ʻoi aku ka kiʻekiʻe o ka maʻi i kaupalena ʻia i ka ate), kahi ala kūpono e loaʻa ai nā hopena hoʻomau. A he 10 pakeneka wale nō o ka poʻe e noho ana me ka mCRC e ola i ʻelima mau makahiki ma hope o ka hōʻoia ʻana. ʻO Arfolitixorin ka mua a ʻo ka folate ikaika wale nō e hoʻoikaika i ka 5-FU, e hoʻonui ai i ka hopena o ka pepehi kanaka.
He aha e lawe ʻia mai kēia ʻatikala:
- Isofol will now submit analyses of the study based on 490 patients enrolled in the study (Japanese patients previously in addendum added to main study) and both the original and new censoring rules will be included in the New Drug Application (NDA).
- Colorectal cancer is the third leading cause of cancer in the world and the second leading cause of cancer mortality with almost one million deaths in 2020.
- Isofol is firmly focused on a comprehensive analysis and expects it will take two – four months from the start of the analysis before top-line results can be communicated.
