FDA Ivomereza Mayesero Ovuta Kwambiri Opumira Opumira

A GWIRITSANI KwaulereKutulutsidwa 5 | eTurboNews | | eTN
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Written by Linda Hohnholz

Direct Biologics yalengeza lero kuti FDA yavomereza kampaniyo kuti ipitilize kuyesa kwachipatala kwa Gawo 3 pogwiritsa ntchito mankhwala ake ofufuza a EV, ExoFlo, pochiza Acute Respiratory Distress Syndrome (ARDS) chifukwa cha Covid-19. Direct Biologics ndi kampani yoyamba komanso yokhayo ya EV kulandira chivomerezo cha FDA Phase 3 cha Investigational New Drug (IND) mpaka pano.  

Mlandu wa Phase 3 udzachitidwa mothandizidwa ndi dzina loyamba la Regenerative Medicine Advanced Therapy (RMAT) lovomerezedwa ndi FDA pamankhwala a EV, zomwe zimapangitsa Direct Biologics kukhala imodzi mwamakampani 70 okha m'mbiri ya FDA kuti apatsidwe mwalamulo RMAT. . Monga njira yofulumira komanso yodziwika bwino, RMAT idapangidwa ndi FDA kuti ifulumizitse kuvomereza kulonjeza kwamankhwala obwezeretsanso omwe amawonetsa kuthekera kochiza matenda oopsa omwe amawopseza moyo. 

"Kulandira chivomerezo cha FDA pa Gawo 3 ndilofunika kwambiri pa Direct Biologics," anatero Mark Adams, Co-Founder ndi CEO. "Kuphatikizana ndi dzina la RMAT, tsopano tili panjira yopita ku malonda ndi mankhwala opulumutsa moyo - ExoFlo. Muyeso wa Gawo 3 uwu wotchedwa "Zimitsani Covid-19" ndi kuyesa kwapadziko lonse lapansi, kosiyanasiyana, kopanda khungu, kosasinthika, koyendetsedwa ndi placebo koyendetsedwa ndi placebo. Cholinga chathu ndikulembetsa odwala omwe ali ndi ARDS m'zipatala ku US, Spain, India, Jordan, Egypt, Lebanon, ndi South Africa, ndikuwonetsa kuchepa kwakukulu kwa imfa potsatira chithandizo cha ExoFlo poyerekeza ndi chisamaliro chokhachokha. Monga apainiya pankhani yamankhwala ochiritsira, ife ku Direct Biologics tikusintha tsogolo lazamankhwala. ” 

"Kaya Covid-19 ikadali mliri kapena ikhala mliri, gawo limodzi losafunikira limakhalabe lofanana: chithandizo chothandizira cha ARDS. Anthu opitilira zaka 65 komanso omwe ali ndi zovuta zina, atadwala SARS-CoV-2, amakhala pachiwopsezo chotenga matenda oopsa komanso ARDS, "atero a Joe Schmidt, Co-Founder ndi Purezidenti. "Kuwulula chitetezo champhamvu komanso kuchepetsa kufa kwa masiku 60, kuyesa kwathu kwa Gawo 2 kunawonetsa kuti ExoFlo imatha kupulumutsa moyo kwa odwala omwe ali m'chipatala ndi ARDS. Kulandira chivomerezo cha FDA kuti mupite ku Gawo 3 ndichinthu chopambana chifukwa palibe chithandizo chodziwika cha ARDS. Madokotala ndi odwala padziko lonse lapansi akhala akuyembekezera yankho kwa nthawi yayitali. ”  

"Kugwira ntchito kuti mukhale ndi ExoFlo ndi mwayi," adatero Dr. Vik Sengupta, Chief Medical Officer. "Zomwe zikuchulukirachulukira zazachipatala zikuwonetsa kuti ExoFlo ndi mankhwala omwe amabweretsa chiyembekezo pakuchiza matenda omwe chisamaliro chawo sichinasinthe kwazaka zambiri. Chiyembekezochi chikukhudzidwa kwambiri ndi nkhani za odwala omwe adalandira chithandizo cha ExoFlo. Sabata yatha, mayi ku Virginia adalumikizananso ndi ana ake atatopa ndi makina olowera mpweya kwa miyezi iwiri chifukwa chopanga ARDS chifukwa cha Covid-2. Koma poyesera komaliza kupulumutsa moyo wa wodwalayo, madotolo a ICU adapempha kuti amuchiritse ndi ExoFlo mothandizidwa mwachifundo, ndipo adachira mozizwitsa. Pali miyandamiyanda ya anthu onga iye amene samatuluka m’chipatala. Tikufuna kusintha nkhaniyi pokhazikitsa ExoFlo ngati chithandizo chagolide cha ARDS ndikupangitsa kuti odwala azipatala padziko lonse lapansi azipezeka.

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Avatar ya Linda Hohnholz

Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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