Ua hoʻolaha ʻo Direct Biologics i kēia lā ua ʻae ka FDA i ka hui e hoʻomau i kāna hoʻokolohua lapaʻau Phase 3 me ka hoʻohana ʻana i kāna lāʻau hoʻokolohua EV, ExoFlo, e mālama i ka Acute Respiratory Distress Syndrome (ARDS) ma muli o Covid-19. ʻO Direct Biologics ka hui EV mua loa a loaʻa ka ʻae ʻia ʻo FDA Phase 3 no kahi hōʻailona Investigational New Drug (IND) a hiki i kēia lā.
E mālama ʻia ka hoʻāʻo ʻana o ka Phase 3 ma lalo o ka mana o ka Regenerative Medicine Advanced Therapy (RMAT) ka inoa i ʻae ʻia e ka FDA no kahi lāʻau lapaʻau EV, e hana ana ʻo Direct Biologics i hoʻokahi o nā hui 70 wale nō i ka mōʻaukala o ka FDA i loaʻa i ka RMAT. . E like me ke ala wikiwiki a me ka hoʻolālā ʻana, ua hana ʻia ka RMAT e ka FDA e hoʻolalelale i ka ʻae ʻia no ka hoʻohiki ʻana i nā lāʻau lapaʻau e hōʻike ana i ka hiki ke mālama i nā maʻi weliweli i ke ola.
"ʻO ka loaʻa ʻana o ka ʻae FDA no ka Phase 3 he mea nui ia no Direct Biologics," wahi a Mark Adams, Co-Founder a me CEO. "I hui pū ʻia me ka hoʻolālā RMAT, aia mākou i kēia manawa ma ke ala wikiwiki i ka hoʻolaha ʻana me kahi lāʻau ola ola-ExoFlo. ʻO kēia hoʻokolohua Phase 3 i kapa ʻia ʻo "Extinguish Covid-19" he hoʻāʻo honua, multicenter, pālua-makapō, randomized, placebo-controlled Phase 3 hoʻāʻo. ʻO kā mākou pahuhopu ka hoʻopaʻa inoa ʻana i nā maʻi me ARDS ma nā kahua haukapila ma waena o US, Sepania, India, Jordan, Egypt, Lebanona, a me ʻApelika Hema, a e hōʻike i kahi hōʻemi nui o ka make ma hope o ka mālama ʻana me ExoFlo i hoʻohālikelike ʻia i ka mālama mālama wale nō. Ma ke ʻano he paionia ma ke kahua o nā lāʻau lapaʻau regenerative, ke hoʻololi nei mākou ma Direct Biologics i ka wā e hiki mai ana o ka lāʻau lapaʻau.
"Inā noho mau ʻo Covid-19 i kahi maʻi maʻi a i lilo paha i mea maʻi, hoʻokahi wahi o ka pono ʻole e hoʻomau ʻia: he therapeutic kūpono no ARDS. ʻO ka poʻe ma luna o 65 mau makahiki a me ka poʻe me nā comorbidities, i ka manawa i loaʻa i ka SARS-CoV-2, e maʻalahi mau i ka piʻi ʻana i ka maʻi koʻikoʻi a me ARDS, "wahi a Joe Schmidt, Co-Founder a me Pelekikena. "Ke hōʻike nei i ka palekana ikaika a me ka hoʻoemi ʻana o ka make ʻana o 60 mau lā, ua hōʻike kā mākou Phase 2 hoʻāʻo e hiki i ExoFlo ke hana i kahi ʻokoʻa hoʻopakele ola nui no nā poʻe maʻi i mālama ʻia me ARDS. ʻO ka loaʻa ʻana o ka ʻae FDA e hoʻomau i ka Phase 3 he mea koʻikoʻi koʻikoʻi no ka mea ʻaʻohe lāʻau lapaʻau i ʻike ʻia no ARDS. Ua kali lōʻihi nā kauka a me nā maʻi ma ka honua no kahi hopena. "
"ʻO ka hana ʻana i ka hoʻomohala ʻana i ExoFlo he kuleana ia," wahi a Kauka Vik Sengupta, Luna Kauka Nui. "Ke hōʻike nei ke kino ulu o ka ʻikepili lapaʻau he lāʻau lapaʻau ʻo ExoFlo e lawe mai i ka manaʻolana i ka mālama ʻana i kahi maʻi i hoʻomaikaʻi ʻole ʻia ke kūlana o ka mālama ʻana i nā makahiki. ʻO kēia manaʻolana ua hopu ʻia e nā moʻolelo o nā maʻi i loaʻa iā ExoFlo no ka mālama ʻana. ʻO ka pule i hala iho nei, ua hui hou ʻia kahi wahine ma Virginia me kāna mau keiki ma hope o ke kaumaha ʻana i ka ventilator mechanical no 2 mau mahina ma muli o ka hoʻomohala ʻana o ARDS i hoʻokomo ʻia e Covid-19. Akā i ka hoʻāʻo hope loa e hoʻopakele i ke ola o ka mea maʻi, ua noi nā kauka ICU e mālama iā ia me ExoFlo ma lalo o ka hoʻohana aloha, a ua hoʻōla hou ʻo ia. He mau miliona ka poʻe e like me ia ʻaʻole i puka i waho o ka haukapila. Makemake mākou e hoʻololi i kēlā moʻolelo ma ka hoʻokumu ʻana iā ExoFlo ma ke ʻano he lāʻau maʻamau gula no ARDS a hiki i nā mea maʻi i nā haukapila a puni ka honua.
He aha e lawe ʻia mai kēia ʻatikala:
- 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.
