I-TC Biopharm (Holdings) PLC ibhengeze ukuba ifumene imvume ye-MHRA kunye neKomiti yeeNdlela zokuziphatha zoPhando ukuze iqalise iimvavanyo zeklinikhi ze-gamma-delta T ye-OmnImmune® yonyango lwe-Acute Myeloid Leukemia (AML).
I-OmnImmune® i-allogeneic unmodified cell therapy ebandakanya iiseli ze-gamma delta T esele zifumene ukuchongwa kwechiza lenkedama kunyango lwezigulana ezinomhlaza wegazi kunye nomongo wethambo. Izilingo zeSigaba se-2/3 ziya kuqalisa ukubhaliswa kwisiqingatha sokuqala sika-2022 e-UK kunye nokwandiswa kwe-US elandelayo kamsinya emva koko.
"Siyavuya kakhulu ukufumana imvume ye-MHRA kunye neeNqobo zoPhando, ephawula inyathelo lokugqibela ekungenisweni kwethu kweprotocol kunye nokuqalisa ngenkqubo yovavanyo lwekliniki yonyango lwethu lwe-AML," utshilo uBryan Kobel, i-CEO ye-TC BioPharm. “Ezithendeni zokubhengeza ukunikezelwa kweziyobisi zethu zeNkedama kwi-FDA, ngoku siye sabonisa ngakumbi amandla ethu okuqhuba iinkqubo ezifanayo zolingo lwezonyango e-US nase-UK/EU. Iziphumo ezincumisayo eziboniswe yi-OmnImmune® kwiSigaba 1b/2a zolingo lwezonyango ziyakhuthaza kwaye zomeleza inkolelo yethu kunyango olusebenzayo lwe-Acute Myeloid Leukemia.”
INTO ONOKUYITHATHA KWELI NQAKU:
- OmnImmune® an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells has already received orphan drug designation for the treatment of patients suffering from the blood and bone marrow cancer.
- The positive results demonstrated by OmnImmune® in Phase 1b/2a clinical trials are encouraging and bolsters our belief in its potential as an effective therapy for Acute Myeloid Leukemia.
- I-TC Biopharm (Holdings) PLC ibhengeze ukuba ifumene imvume ye-MHRA kunye neKomiti yeeNdlela zokuziphatha zoPhando ukuze iqalise iimvavanyo zeklinikhi ze-gamma-delta T ye-OmnImmune® yonyango lwe-Acute Myeloid Leukemia (AML).
