用于緩解嚴(yán)重花生過(guò)敏反應(yīng)的DNA疫苗ASP0892獲FDA快通道審批資格
發(fā)布時(shí)間:2018-03-12 21:15
本文選題:DNA疫苗ASP 切入點(diǎn):FDA 出處:《國(guó)際藥學(xué)研究雜志》2017年04期 論文類(lèi)型:期刊論文
【摘要】:正阿斯特拉藥業(yè)公司宣布DNA疫苗ASP0892獲FDA快通道審批資格,用于緩解嚴(yán)重的花生過(guò)敏反應(yīng)。該藥是應(yīng)用LAMP-Vax平臺(tái)生成的新DNA疫苗。Ⅰ期臨床試驗(yàn)評(píng)價(jià)其對(duì)花生過(guò)敏的免疫反應(yīng)、耐受性和安全性;ㄉ^(guò)敏是威脅生命的致命性過(guò)敏,微量暴露即可引起過(guò)敏反應(yīng)。目前尚無(wú)批準(zhǔn)的有效預(yù)防藥物,只有攜帶腎上腺素自動(dòng)注射器應(yīng)對(duì)意外發(fā)生的病例。LAMP-Vax平臺(tái)是突破性技術(shù),用于多種疾病疫苗研發(fā)。它包括編碼溶酶體有關(guān)的膜蛋白的短DNA序列,利用人體的自然生物化學(xué),產(chǎn)生更完全的免疫反應(yīng),包
[Abstract]:DNA vaccine ASP0892 has been approved by FDA Fast Channel for severe peanut allergies. The drug is a new DNA vaccine produced by the LAMP-Vax platform. Phase I clinical trials evaluated its immune response to peanut allergies. Tolerance and safety. Peanut allergies are life-threatening fatal allergies, which can be caused by exposure to small amounts. There is no approved effective prophylactic drug. Only automated epinephrine syringes for accidental cases. The LAMP-Vax platform is a breakthrough technology for developing vaccines for multiple diseases. It includes short DNA sequences that encode lysosomal membrane proteins, using the body's natural biochemistry. Produce a more complete immune response, package
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