Uvavanyo olutsha lweLandmark yeSigaba sesi-3 esiNxinzelela ngokuNxibelela ngokuNxinzelela ngokuPheleleyo

I-Direct Biologics ibhengeze namhlanje ukuba i-FDA ivume inkampani ukuba iqhubeke nolingo lwayo lwezonyango lweSigaba sesi-3 isebenzisa ichiza lophando le-EV, i-ExoFlo, ukunyanga i-Acute Respiratory Distress Syndrome (ARDS) ngenxa ye-Covid-19. I-Direct Biologics yinkampani yokuqala kunye ne-EV kuphela ukufumana imvume yeSigaba sesi-3 se-FDA kuPhando olutsha lweChiza (IND) olubonisayo ukuza kuthi ga ngoku.              

Ulingo lweSigaba se-3 luya kuqhutywa phantsi kwenkxaso yokuqala yonyango lwe-Regenerative Medicine Advanced (RMAT) evunywe yi-FDA yonyango lwe-EV, okwenza i-Direct Biologics ibe yinkampani ye-70 kuphela kwimbali ye-FDA ukuba inikezelwe ngokusemthethweni i-RMAT. . Njengomkhondo okhawulezayo kunye nokutyunjwa kwempumelelo, i-RMAT yadalwa yi-FDA ukukhawulezisa ukuvunywa kwamayeza athembisayo okuvuselela abonisa ukukwazi ukunyanga izifo ezinobungozi obunobomi.

"Ukufumana imvume ye-FDA kwiSigaba se-3 yinto ephambili kwi-Biologics eNgqongileyo," watsho uMark Adams, uMseki-Msebenzi kunye ne-CEO. “Idityaniswe negama le-RMAT, ngoku sikwindlela ekhawulezileyo eya ekurhwebeni ngechiza elinokusindisa ubomi—i-ExoFlo. Olu lingo lweSigaba sesi-3 olunesihloko esithi “Cima i-Covid-19” lulingo lweSigaba sesi-3 esilawulwa yi-placebo. Injongo yethu kukubhalisa izigulana ezine-ARDS kwiziza zezibhedlele kulo lonke elase-US, e-Spain, e-Indiya, e-Jordan, e-Egypt, e-Lebhanon naseMzantsi Afrika, kunye nokubonisa ukwehla okubonakalayo kokusweleka okulandela unyango nge-ExoFlo xa kuthelekiswa nomgangatho wokhathalelo lodwa. Njengoovulindlela kwicandelo lonyango oluhlaziyayo, thina kwi-Direct Biologics siyalitshintsha ikamva lamayeza. ”

"Nokuba i-Covid-19 ihlala ingubhubhani okanye iba ngubhubhani, enye indawo yemfuno engafezekiyo ihlala ifana: unyango olusebenzayo lwe-ARDS. Abantu abangaphezulu kweminyaka engama-65 kunye nabo bane-comorbidities, xa sele bosulelwe yi-SARS-CoV-2, baya kuhlala besengozini yokuqhubela phambili kusulelo oluqatha kunye ne-ARDS, utshilo uJoe Schmidt, uMseki kunye noMongameli. “Ebonisa ukhuseleko olomeleleyo kunye nokuncitshiswa kokusweleka kweentsuku ezingama-60, ulingo lwethu lweSigaba sesi-2 lubonise ukuba i-ExoFlo inokwenza umahluko omkhulu osindisa ubomi kwizigulana ezilaliswe esibhedlele nge-ARDS. Ukufumana imvume ye-FDA yokuqhubekeka kwiSigaba sesi-3 yimpumelelo enkulu kuba akukho nyango lwaziwayo lwe-ARDS. Oogqirha kunye nezigulana kwihlabathi liphela kudala belindele isisombululo. ”

"Ukusebenza ukuphuhlisa i-ExoFlo lilungelo," kusho uDkt Vik Sengupta, iGosa eliyiNtloko lezoNyango. “Ukwanda kwedatha yezonyango kubonisa ukuba i-ExoFlo lichiza elizisa ithemba kunyango lwesifo ubungaphucukanga umgangatho wokhathalelo lwaso kumashumi eminyaka. Eli themba libanjwe kabuhlungu ngamabali ezigulana ezifumene unyango lwe-ExoFlo. Kwiveki ephelileyo, inkosikazi yaseVirginia yaphinda yadityaniswa nabantwana bayo emva kokuphelelwa ngumoya kangangeenyanga ezi-2 ngenxa yophuhliso lwe-ARDS olubangelwa yi-Covid-19. Kodwa kwiinzame zokugqibela zokusindisa ubomi besigulana, oogqirha be-ICU bacela ukumnyanga nge-ExoFlo phantsi kovelwano, kwaye wachacha ngendlela engummangaliso. Kukho izigidi zabantu abafana naye abangaze baphume esibhedlele. Sifuna ukulitshintsha eli bali ngokuseka i-ExoFlo njengonyango olusemgangathweni lwe-ARDS kwaye siyenze ifikeleleke kwizigulana ezikwizibhedlele kwihlabathi jikelele.