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# Inovio Pharma Phase 3 Trial on Clinical Hold
- URL: https://www.fdaweb.com/inovio-pharma-phase-3-trial-on-clinical-hold/
- Published: 2016-10-24T12:00:00.000Z
- Updated: 2026-09-14T21:41:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137146

FDA has placed a clinical hold on an Inovio Pharmaceuticals proposed Phase 3 clinical program for VGX-3100, requesting additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device. The company says it is working with the agency and expects that the requested data will be available before the end of the year. Inovio estimates that the start of the clinical study will be delayed until the first half of 2017.

VGX-3100 is an investigational DNA immunotherapy candidate designed to treat precancers and cancers caused by human papillomavirus. Intramuscular injection of the plasmid DNA immunotherapy is followed by electroporation using the company’s Cellectra delivery device. In a Phase 2 trial, VGX-3100 induced regression of precancerous cervical disease and cleared HPV infection with robust T cell responses, according to the company.