信源地址:http://ir.inovio.com/news/news-releases/news-releases-details/2017/Inovio-Begins-Phase-3-Clinical-Trial-of-VGX-3100-for-the-Treatment-of-HPV-Related-Cervical-Pre-Cancer/default.aspx
Adam在24日发布Twitter上称:“Inovio再一次成为“伟大的”试验。我们想一下,2期3100人的试验延期完成,现在3期试验又被FDA叫停。” 参考REFERENCE [1] Inovio Announces FDA Request for Additional Information For Phase III Program Trial Initiation Delayed (htt...
INOVIO公司将在美国阴道镜及宫颈病理学会(ASCCP)年会的网络会议环节发表此项研究结果,名为VGX-3100治疗HPV16/18导致的肛门HSIL的非盲、二期研究的初步结果(Preliminary Results of an Open-label Phase 2 Study of VGX-3100 for the Treatment of HPV16 and/or HPV-18 (HPV16/18) related Anal HSIL)。 肛门异...
我们无法保证在此评估后继续进行VGX-3100的临床开发。 如下是原文,具体位置是40页。 In connection with our proposal to the FDA to amend the protocol for our REVEAL 2 (HPV-303) Phase 3 clinical trial of VGX-3100 in women with HPV-16/18 cervical high-grade dysplasia (HSIL), to reflect a bio...
VGX-3100, now in a Phase 3 trial, is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 is designed to ...
Here we report the results of a Phase II study assessing the safety and efficacy of VGX-3100 in 167 women with biopsy-proven CIN 2/3 with concurrent HPV16/18 infection. The randomized, placebo-controlled, double-blind study evaluated cervical tissue changes after three 6 mg intramuscular doses...
Immunotherapy that significantly impacts the clinical status of advanced cervical intraepithelial neoplasia (CIN) has the potential to provide physicians an important alternative to surgery to treat CIN 2/3 disease. Our previous two Phase I studies of VGX3100, a highly optimised DNA immunotherapy for ...
Phase 2b results of HPV immunotherapy VGX-3100 announced
We have previously demonstrated the immunogenicity of VGX-3100, a multicomponent DNA immunotherapy for the treatment of Human Papillomavirus (HPV)16/18-positive CIN2/3 in a phase 1 clinical trial. Here, we report on the ability to boost immune responses with an additional dose of VGX-3100. ...
VGX-3100 drives regression of HPV16/18 CIN2/3 and robust cellular immune responses in blood and cervical tissue in a blinded, randomized, placebo controlled phase 2b studyObjectives: Assessment of the safety, efficacy and immunogenicity of VGX-3100 in women with biopsy-proven CIN2/3 withHPV16 ...