I-Paradigm Biopharmaceuticals Ltd. ibike ukuba izifundo zokuqala ziye zahlanjululwa kunye ne-dose e-United States (US) kwi-PARA_OA_002 yolingo olubalulekileyo lweklinikhi, ukuvavanya injectable pentosan polysulfate sodium (PPS/Zilosul®) yonyango lweentlungu ezinxulumene ne-knee osteoarthritis (kOA). ). Isifundo sokuqala se-randomization saqinisekiswa kwiYunivesithi yaseNorthwestern, eChicago, nguPhando oPhambili, uDkt Thomas Schnitzer MD, Ph.D.
ISigaba se-III esibalulekileyo sehlabathi jikelele, i-PARA_OA_002, uphando ngoku luhlola kwaye lubhalisa izifundo kwiindawo ezisibhozo kulo lonke elase-Australia kunye ne-21 yeendawo ezikhethiweyo ze-56 kwi-US Clinical trial site activation ibe yingqwalasela ebalulekileyo kwiParadigm ukususela ekuqaleni konyaka wekhalenda ukuze Ichibi elikhulu labaviwa abanokubakho ukuba bachongwe kwiindawo zonke ezivuliweyo kwaye baqalise inkqubo yokuhlola. Ukuqaliswa kwesayithi e-US kuya kuqhubeka, kwaye iisayithi zase-UK kunye ne-EU nazo ziqaliswa kuyo yonke i-CY22.
“Ukuba nezifundo zethu zokuqala zingacwangciswanga e-US linyathelo elibalulekileyo kwinkqubo yezonyango ye-OA. Iqela leklinikhi yeParadigm liye lasebenza ngokuzikhandla ekuqaliseni nasekusebenzeni iisayithi kulo lonke elase-US, kwaye sibona inani elikhulu lezifundo ezingena kwisigaba sokuhlola kulo lonke elase-US Sijonge phambili ekuqhubeni umfutho oqinileyo kwinkqubo yeSigaba sesi-III kunye nokuxela ukuqashwa okubalulekileyo. Iziganeko ezibalulekileyo kubaninizabelo bethu,” utshilo uGqr. Donna Skerrett, iGosa eliyiNtloko lezoNyango leParadigm kunye ne-CEO yeThutyana.
INTO ONOKUYITHATHA KWELI NQAKU:
- Uphononongo olungundoqo lwehlabathi jikelele lweSigaba sesi-III, i-PARA_OA_002, ngoku luhlola kwaye lubhalisa izifundo kwiindawo ezisibhozo kulo lonke elase-Australia kunye nama-21 kumaziko angama-56 akhethiweyo eU.
- Ukusebenza kwendawo yovavanyo lweklinikhi kuye kwaba yingqwalasela ebalulekileyo yeParadigm ukususela ekuqaleni konyaka wekhalenda ukwenzela ukuba i-pool enkulu yabaviwa abanokuthi bachongwe kwiindawo ezisebenzayo kwaye baqale inkqubo yokuhlola.
- Iqela leklinikhi leParadigm belisebenza ngokuzimisela ukuqalisa nokwenza iisayithi zisebenze kulo lonke elaseU.