I-Priothera Ltd. namhlanje ibhengeza ukuba i-US Food and Drug Administration (i-FDA) inike imvume yokuqhubeka nesicelo seNkampani yoPhando lweChiza eNtsha (IND) ukuqala isifundo sayo esibalulekileyo seSigaba se-2b / 3 se-mocravimod (ebizwa ngokuba yi-MO-TRANS).
I-Priothera iya kuqalisa i-MO-TRANS iSigaba se-2b / 3 sehlabathi jikelele isifundo eYurophu, e-US naseJapan, ukuvavanya ukusebenza kunye nokhuseleko lwe-mocravimod njengonyango oluncedisayo kunye nokugcinwa konyango kubantu abadala aba-Acute Myeloid Leukemia (AML) abafumana i-allogen hematopoietic stem cell transplant (HSCT) ). Uphononongo lwe-MO-TRANS kulindeleke ukuba luqale kwisiqingatha sesibini se-2022 kwaye idatha yokuqala evela kolu phononongo kulindeleke ukuba iphele ngo-2024.
I-Allogenic stem cell transplantation iyona ndlela yodwa enokuthi iphilise izigulane ze-AML, nangona kunjalo ukhetho lonyango lwangoku lusadibaniswa nenani eliphezulu lemiphumo emibi, kunye namazinga aphezulu okufa.
UFlorent Gros, uMseki-Msebenzi kunye ne-CEO ye-Priothera, wathi "Imvume ye-FDA IND ukuqalisa uphando lwe-MO-TRANS lokuhlola i-mocravimod kwizigulane ze-AML ezihamba nge-allogeneic HSCT yenye isiganeko esibalulekileyo se-Priothera. Sisendleleni yokuqalisa olu lingo lubalulekileyo lweSigaba se-2b/3 kwaye sijonge phambili ekusebenzeni kunye neqela elikhulu labaphandi abanomdla kulo lonke elase-US, iYurophu kunye ne-Asiya, esabelana nenjongo yethu yokuzisa i-mocravimod kwizigulane njengonyango olongezelelweyo kunye nokugcinwa. ye-AML kunye nezinye izinto ezinobungozi be-hematological."
INTO ONOKUYITHATHA KWELI NQAKU:
- Sisendleleni yokuqalisa olu lingo lubalulekileyo lweSigaba se-2b/3 kwaye sijonge phambili ekusebenzeni kunye neqela elikhulu labaphandi abanomdla kulo lonke elase-US, iYurophu kunye ne-Asiya, ababelana nenjongo yethu yokuzisa i-mocravimod kwizigulane njengonyango lokuncedisa kunye nokugcinwa. ngenxa ye-AML kunye nezinye izifo ze-hematological ezinokubakho.
- I-Priothera iya kuqalisa i-MO-TRANS iSigaba se-2b / 3 sehlabathi jikelele isifundo eYurophu, e-US naseJapan, ukuhlola ukusebenza kunye nokhuseleko lwe-mocravimod njengonyango oluncedisayo kunye nokugcinwa konyango kubantu abadala be-Acute Myeloid Leukemia (AML) izigulane eziphantsi kwe-allogen hematopoietic stem cell transplant (HSCT) ).
- Uphononongo lwe-MO-TRANS kulindeleke ukuba luqale kwisiqingatha sesibini se-2022 kwaye idatha yokuqala evela kolu phononongo kulindeleke ukuba iphele ngo-2024.