INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
Summary
This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (HPV-11)-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) as defined by age at first diagnosis \<12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.
Timeline
- Start
- 2020-10-07
- Primary completion
- 2022-12-15
- Completion
- 2022-12-15
Outcome
Met primary endpoint
release “In the open-label, multicenter trial (NCT:04398433) , INO-3107 demonstrated statistical significance based on the clinical endpoint of a reduction in the number” inovio.com ↗
release “Treatment with INO-3107 resulted in 16 of 21 (76%) participants with a reduction in number of surgical interventions compared with previous year” inovio.com ↗
release “Overall, 81.3% (26/32) patients had a decrease in surgical interventions in the year after INO-3107 administration versus the prior year” inovio.com ↗
release “Treatment with INO-3107 achieved statistical significance based on clinical endpoint of reduction in overall number of surgical interventions compared with previous year” inovio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INO-3107 | Other / unclassified | 6.25 mg/ml | Intramuscular |