Ua hoʻolaha ʻo TC Biopharm (Holdings) PLC ua loaʻa iā MHRA a me Research Ethics Committee nā ʻae e hoʻomaka i ka gamma-delta T cell therapy clinical trials o OmnImmune® no ka mālama ʻana i ka Acute Myeloid Leukemia (AML).
ʻO OmnImmune® kahi allogeneic unmodified cell therapy i hoʻolaʻa ʻia a hoʻonui ʻia ka gamma delta T cell ua loaʻa i kahi inoa lāʻau keiki makua ʻole no ka mālama ʻana i nā poʻe maʻi e loaʻa ana i ke koko a me ka iwi iwi. E hoʻomaka ka hoʻāʻo ʻana o ka Phase 2/3 i ka hapa mua o 2022 ma UK me ka hoʻonui ʻana i ka US ma hope koke iho.
"ʻOliʻoli loa mākou i ka loaʻa ʻana o ka MHRA a me ka Research Ethics approvals, kahi e hōʻailona ai i ka hana hope loa i kā mākou protocol hoʻouna ʻana a hoʻomaka ma o ke kaʻina hoʻokolohua lapaʻau o kā mākou AML therapy proprietary," wahi a Bryan Kobel, Luna Nui o TC BioPharm. "Ma ke kuʻekuʻe wāwae o ka hoʻolaha ʻana i kā mākou Orphan Drug Dsignation mai ka FDA, ua hōʻike hou mākou i ko mākou hiki ke holo i nā kaʻina hana like no nā hoʻokolohua lapaʻau ma US a me UK / EU. ʻO nā hopena maikaʻi i hōʻike ʻia e OmnImmune® i ka Phase 1b/2a hoʻokolohua lapaʻau e paipai a hoʻoikaika i ko mākou manaʻoʻiʻo i kona hiki ke lilo i mea lapaʻau maikaʻi no ka Acute Myeloid Leukemia.
