2016年11月22日

2016年11月22日2:58am FDA和Aduro同意更改crs - 207年FDA已經解除了部分臨床試驗協議把它放置在試驗Aduro生物技術的crs - 207上個月癌症疫苗。決議清除Aduro恢複注冊在一個持續的I / II期臨床試驗和推進籌備一項研究測試crs - 207結合一種anti-PD-1化合物。crs - 207是由再造單核細胞增多性李斯特氏菌中性的細菌,使其表達mesothelin蛋白質。這個過程的目的是確保細菌不能導致李斯特菌,但引發抗癌免疫反應。Aduro障礙,是李斯特菌的兩例發生在350年之前治療的患者的起始部分臨床。這些病例相關的醫療設備端口,空間在細菌生物膜形成。伯克利分校總部Aduro下車從臨床下持有通過調整其試驗協議削減未來類似案件發生的風險,並確保在事件反應迅速。阻止生物膜的威脅,Aduro排除某些患者難以被去掉假crs - 207試驗的設備。的知識潛力crs - 207與假肢給人們造成麻煩回到年。Anza療法測試crs - 207在人類之前出售的資產在2009年Aduro。 The exclusion criteria for an Anza trial protocol filed late in 2007 bar patents with “artificial (prosthetic) joint or other artificial implant or devices that cannot be easily removed” from participating in the study. Aduro has gradually tweaked the wording of the line since starting its own clinical trials of CRS-207 in 2011. The first protocol included a near word-for-word copy of Anza’s line about prosthetics, adding only that “there are some exceptions.” A subsequent trial protocol listed “dental and breast implants and biliary stents and mediports” as the exceptions. In 2013, Aduro tweaked the exclusion criteria to allow patients with prosthetic heart valves and other previously-prohibited implants into its studies, provided the device was placed at least one year ago and hadn’t previously caused infections. The new wording of the exclusion criteria is yet to go live on ClinicalTrials.gov, but Aduro’s statement suggests it will place greater restrictions on the ability of people with prosthetic implants to join its studies. Aduro has also agreed with FDA to extend patient surveillance and give antibiotics to recipients of CRS-207 who may take immunosuppressive drugs. These changes prompted FDA to give Aduro the green light to resume enrolling patients in trials of CRS-207. Aduro plans to start a Phase II trial of CRS-207 in combination with an anti-PD-1 drug in mesothelioma patients in the first half of next year. Read more on