Ọnwụnwa Landmark ọhụrụ maka Ọrịa Nsogbu iku ume nke Atọ nke 3

Direct Biologics kwuputara taa na FDA anabatala ụlọ ọrụ ahụ ka ọ gaa n'ihu na nnwale ụlọ ọgwụ ya nke 3 site na iji ọgwụ EV nyocha ya, ExoFlo, iji gwọọ Ọrịa Respiratory Distress Syndrome (ARDS) n'ihi Covid-19. Direct Biologics bụ ụlọ ọrụ EV mbụ na naanị nweta nkwado FDA Phase 3 maka ihe ngosi ọgwụ ọhụrụ nyocha (IND) ruo taa.              

A ga-eme nnwale nke usoro 3 n'okpuru nkwado nke mbụ Regenerative Medicine Advanced Therapy (RMAT) nke FDA kwadoro maka ọgwụgwọ EV, na-eme Direct Biologics otu n'ime naanị ụlọ ọrụ 70 na akụkọ ihe mere eme nke FDA ka enyere ya RMAT n'ihu ọha. . Dị ka usoro egwu ngwa ngwa na aha ọganihu, FDA mere RMAT iji mee ka nkwenye dị ngwa maka ọgwụ ndị na-emeghachi omume na-egosi ike ịgwọ ọrịa ndị na-eyi ndụ egwu.

"Ịnata nkwado FDA maka usoro nke 3 bụ isi ihe dị mkpa maka Direct Biologics," Mark Adams, Co-Founder na CEO kwuru. "N'ijikọta ya na aha RMAT, anyị nọ ugbu a n'ụzọ dị ngwa maka ịzụ ahịa yana ọgwụ nwere ike ịzọpụta ndụ-ExoFlo. Ọnwụnwa nke agba nke atọ a akpọrọ “Extinguish Covid-3” bụ ikpe mba ụwa, ọtụtụ etiti, kpuru ìsì abụọ, enweghị usoro, nnwale nke na-achịkwa placebo. Ebumnobi anyị bụ ịdebanye aha ndị ọrịa nwere ARDS na saịtị ụlọ ọgwụ n'ofe US, Spain, India, Jordan, Egypt, Lebanon, na South Africa, na igosipụta mbelata ọnwụ dị ukwuu na-eso ọgwụgwọ na ExoFlo ma e jiri ya tụnyere ọkọlọtọ nlekọta naanị. Dị ka ndị ọsụ ụzọ n'ihe gbasara ọgwụgwọ ọgwụgwọ na-emegharị ahụ, anyị na Direct Biologics na-agbanwe ọdịnihu nke ọgwụ. "

“Ma Covid-19 ka bụ ọrịa na-efe efe ma ọ bụ bụrụ ọrịa na-efe efe, otu mpaghara mkpa na-enweghị mkpa ka bụ otu: ọgwụgwọ dị irè maka ARDS. Ndị mmadụ gafere afọ 65 na ndị nwere ọrịa na-efe efe, ozugbo butere SARS-CoV-2, ga-adị mfe mgbe niile ka ọ bụrụ nnukwu ọrịa na ARDS, "Joe Schmidt, Onye nchoputa na Onye isi ala kwuru. “N'igosipụta nchekwa siri ike yana mbelata ọnwụ nke ụbọchị 60, nnwale anyị nke abụọ gosipụtara na ExoFlo nwere ike ime nnukwu mgbanwe na-azọpụta ndụ maka ndị ọrịa nọ n'ụlọ ọgwụ nwere ARDS. Ịnata nkwado FDA ka ọ gaa n'ihu na-agba nke 2 bụ nnukwu ihe ịga nke ọma n'ihi na ọ dịghị ọgwụgwọ a ma ama maka ARDS. Ndị dọkịta na ndị ọrịa n'ofe ụwa na-eche ogologo oge maka ngwọta. "

"Ịrụ ọrụ iji zụlite ExoFlo bụ ihe ùgwù," ka Dr. Vik Sengupta, Onye isi nlekọta ahụike kwuru. "Otu na-eto eto nke data ụlọ ọgwụ na-egosi na ExoFlo bụ ọgwụ na-eweta olileanya na ọgwụgwọ ọrịa nke ụkpụrụ nlekọta na-adịghị mma n'ime iri afọ. Olileanya a na-adọrọ mmasị nke ukwuu site na akụkọ banyere ndị ọrịa natara ExoFlo maka ọgwụgwọ. Naanị izu gara aga, otu nwanyị nọ na Virginia jikọtara ya na ụmụ ya mgbe ọ nwụsịrị na igwe ikuku ikuku maka ọnwa abụọ n'ihi mmepe ARDS sitere na Covid-2. Mana na mbọ ikpeazụ iji zọpụta ndụ onye ọrịa, ndị dibịa ICU rịọrọ ka e jiri ExoFlo gwọọ ya n'okpuru ọmịiko, ọ gbakere n'ụzọ ọrụ ebube. E nwere ọtụtụ nde ndị dị ka ya na-adịghị eme ka ọ pụta n'ụlọ ọgwụ. Anyị chọrọ ịgbanwe akụkọ ahụ site na iguzobe ExoFlo dị ka ọgwụgwọ ọkọlọtọ ọla edo maka ARDS na ime ka ndị ọrịa nweta ya n'ụlọ ọgwụ gburugburu ụwa.