The article reports on the approval given by the U.S. Food and Drug Administration to the investigational new drug application of VGX Pharmaceuticals for its deoxyribunucleic acid (DNA) vaccine for cervical cancer therapy, VGX-3100. VGX is planning to initiate the Phase I clinical study for ...
FDA还指出,REVORE 1治疗组的癌发病率更高,可能是由于试验设计而不是候选疫苗,需要进一步考虑VGX-3100与标准治疗相比的效益-风险情况,因此,FDA建议对REVEAL 2方案进行额外修改,以解决试验期间进展的可能性。 根据FDA的这一指导意见,我们计划修改并继续REVEAL 2试验直至完成,并将在分析REVEAL 2结果后评估VGX-3100项目...