Direct Biologics ua fa'ailoa mai i le aso ua fa'amaonia e le FDA le kamupani e fa'agasolo i lona Vaega 3 fa'ata'ita'iga fa'apitoa e fa'aaoga ai lana su'esu'ega EV vaila'au, ExoFlo, e togafitia ai le Acute Respiratory Distress Syndrome (ARDS) ona o le Covid-19. Direct Biologics o le kamupani muamua ma e na'o le EV na maua le faamaoniga a le FDA Phase 3 mo se fa'ailoga Investigational New Drug (IND) e o'o mai i le taimi nei.
O le fa'amasinoga o le Vaega 3 o le a faia i lalo o le fa'aulufalega o le ulua'i Regenerative Medicine Advanced Therapy (RMAT) fa'ailoga ua fa'atagaina e le FDA mo se fa'ata'ita'iga a le EV, ma avea ai le Direct Biologics o se tasi o kamupani e 70 i le tala fa'asolopito o le FDA ua tu'uina aloa'ia le RMAT. . E pei o le auala vave ma faʻailoga faʻapitoa, o le RMAT na faia e le FDA e faʻavaveina ai le faʻatagaina mo le folafolaina o vailaʻau faʻafouina e faʻaalia ai le mafai ona togafitia faʻamaʻi ogaoga e lamatia ai le ola.
"O le mauaina o le faamaoniga a le FDA mo le Vaega 3 o se mea taua tele mo Direct Biologics," o le tala lea a Mark Adams, Co-Founder ma Pule Sili. "Faʻatasi ma le igoa RMAT, ua tatou i ai nei i luga o se auala faʻavavevave agai atu i faʻatauga faʻatasi ma se vailaʻau faʻaola ola-ExoFlo. O lenei fa'ata'ita'iga o le Vaega 3 ua fa'aulutalaina "Toe Covid-19" ose fa'asalalauga fa'ava-o-malo, fa'ato'a-lua-tauaso, fa'ata'ita'i, fa'ata'ita'iina i le nofoaga 3 fa'ata'ita'iga. O la matou faʻamoemoe o le lesitalaina o tagata mamaʻi ma ARDS i nofoaga o falemaʻi i US, Sepania, Initia, Jordan, Aikupito, Lepanona, ma Aferika i Saute, ma faʻaalia se faʻaitiitiga taua o le tino pe a maeʻa togafitiga ma ExoFlo pe a faʻatusatusa i tulaga masani o le tausiga. I le avea ai ma paionia i le vaega o togafitiga faafomaʻi toe faʻafouina, o matou i Direct Biologics o loʻo suia le lumanaʻi o vailaʻau.
"Pe tumau pea le Covid-19 o se faʻamaʻi pe avea ma faʻamaʻi, o le tasi vaega o manaʻoga e leʻi faʻamalieina e tumau pea: o se togafitiga aoga mo ARDS. O tagata e sili atu i le 65 tausaga ma i latou e maua i faʻamaʻi faʻamaʻi, pe a aʻafia i le SARS-CoV-2, o le a masani ona faʻamaʻi i le alualu i luma i faʻamaʻi ogaoga ma ARDS, ”o le tala lea a Joe Schmidt, Co-Founder ma le Peresetene. "O le faʻaalia o le saogalemu ma le faʻaitiitia o le 60-aso faʻaola, o le matou Vaega 2 faʻataʻitaʻiga na faʻaalia ai e mafai e ExoFlo ona faia se eseesega faʻaola ola mo tagata mamaʻi ile falemaʻi ile ARDS. O le mauaina o le fa'atagaga a le FDA e fa'agasolo atu i le Vaega 3 ose tulaga mata'ina tele ona e leai se togafiti fa'apitoa mo ARDS. O fomaʻi ma gasegase i le salafa o le lalolagi ua leva ona faʻatali mo se fofo.
"O le galue e atiina ae ExoFlo o se avanoa," o le tala lea a Dr. Vik Sengupta, Ofisa Sili o Fomaʻi. "O le faʻatupulaia o le tino o faʻamaumauga faʻapitoa e faʻaalia ai o ExoFlo o se vailaʻau e aumaia ai le faʻamoemoe i le togafitiga o se faʻamaʻi e leʻi faʻaleleia le tulaga o le tausiga i le tele o tausaga. O lenei faʻamoemoe e sili ona puʻeina e tala o gasegase na maua ExoFlo mo togafitiga. I le vaiaso na teʻa nei, na toe feiloaʻi ai se fafine i Virginia ma lana fanau ina ua faʻavaivai i luga o le masini ventilator mo le 2 masina ona o le atinaʻeina o le ARDS na aʻafia e Covid-19. Ae i se taumafaiga mulimuli e laveai le ola o le tagata maʻi, na talosaga le fomaʻi o le ICU e togafitia o ia i le ExoFlo i lalo o le faʻaaogaina alofa, ma na ia toe faʻaleleia faavavega. E faitau miliona tagata e pei o ia e le mafai ona alu ese mai le falemaʻi. Matou te mananaʻo e suia lena tala e ala i le faʻavaeina o ExoFlo e avea ma togafitiga auro mo ARDS ma faʻafaigofie ona maua e tagata gasegase i falemaʻi i le lalolagi atoa.
OA MEA E AVEA MAI LENEI TUSI:
- The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the FDA for an EV therapeutic, making Direct Biologics one of only 70 companies in the history of the FDA to have been officially awarded RMAT.
- “The growing body of clinical data indicates that ExoFlo is a drug that brings hope to the treatment of a disease for which the standard of care has not improved in decades.
- Our objective is to enroll patients with ARDS in hospital sites across US, Spain, India, Jordan, Egypt, Lebanon, and South Africa, and to demonstrate a significant mortality reduction following treatment with ExoFlo compared to standard of care alone.
