I-TC Biopharm (Holdings) PLC yamemezela ukuthi isithole izimvume ze-MHRA kanye neKomidi Lezimiso Zocwaningo ukuze kuqalwe izivivinyo zomtholampilo ze-gamma-delta T cell therapy ye-OmnImmune® yokwelashwa kwe-Acute Myeloid Leukemia (AML).
I-OmnImmune® i-allogeneic unmodified cell therapy ehlanganisa amaseli e-gamma delta T avuliwe futhi anwetshiwe isivele ithole igama lesidakamizwa esiyintandane sokwelapha iziguli ezinomdlavuza wegazi nomnkantsha. Izivivinyo zeSigaba 2/3 zizoqala ukubhaliswa engxenyeni yokuqala ka-2022 e-UK ngokunwetshwa e-US ngokulandelayo maduze nje.
"Sijabule kakhulu ukuthola izimvume ze-MHRA kanye Nezimiso Zokuziphatha Zocwaningo, okuphawula isinyathelo sokugcina ekuhambiseni kwethu iphrothokholi futhi siqale ngenqubo yokuhlolwa komtholampilo yokwelashwa kwethu kwe-AML," kusho uBryan Kobel, oyi-CEO ye-TC BioPharm. “Ezithendeni zokumemezela Ukukhishwa Kwezidakamizwa Zezintandane ku-FDA, manje sesiphinde sabonisa amandla ethu okuqhuba izinqubo ezifanayo zokuhlolwa kwemitholampilo e-US nase-UK/EU. Imiphumela emihle eboniswa yi-OmnImmune® esiGabeni 1b/2a sokuhlolwa kwemitholampilo iyakhuthaza futhi iqinisa inkolelo yethu emandleni ayo njengokwelapha okuphumelelayo kwe-Acute Myeloid Leukemia.”
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- I-OmnImmune® i-allogeneic unmodified cell therapy ehlanganisa amaseli e-gamma delta T avuliwe futhi anwetshiwe isivele ithole igama lesidakamizwa esiyintandane sokwelapha iziguli ezinomdlavuza wegazi nomnkantsha.
- Imiphumela emihle eboniswa i-OmnImmune® esiGabeni 1b/2a sokuhlolwa kwemitholampilo iyakhuthaza futhi iqinisa inkolelo yethu emandleni ayo njengokwelapha okusebenzayo kwe-Acute Myeloid Leukemia.
- I-TC Biopharm (Holdings) PLC yamemezela ukuthi isithole izimvume ze-MHRA kanye neKomidi Lezimiso Zocwaningo ukuze kuqalwe izivivinyo zomtholampilo ze-gamma-delta T cell therapy ye-OmnImmune® yokwelashwa kwe-Acute Myeloid Leukemia (AML).