Trial reportThe Lancet. Respiratory medicine2025
PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial.
Trial report in The Lancet. Respiratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04724980 (A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
Who cites it
11 citing papers in PubMed.
- Trial
- Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP.The Laryngoscope · 2026Article
- Patient Perspectives on Systemic Bevacizumab Treatment for Recurrent Respiratory Papillomatosis.Laryngoscope investigative otolaryngology · 2026Article
- Comparison of COBioengineering (Basel, Switzerland) · 2026Article
- Therapeutic Vaccines for Chronic Viral Infections: From Immune Modulation to Clinical Translation.Vaccines · 2026Review
- A year in pharmacology: new drugs approved by the US food and drug administration in 2025.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Factors influencing HPV vaccination intention and uptake behaviors among medical students based on the health belief model and vaccine hesitancy theory: a cross-sectional study.Frontiers in public health · 2026Article
- Zopapogene Imadenovec: First Approval.Molecular diagnosis & therapy · 2026Review
- From surgery to immunotherapy: Papzimeos as the first FDA-approved therapy for recurrent respiratory papillomatosis (RRP).Annals of medicine and surgery (2012) · 2025Article
- DNA Immunotherapy (INO-3107) Results in Long-Term Surgery Reduction in RRP.The Laryngoscope · 2025Observational
- Disease Control and Voice Outcomes Following Treatment With PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis.Journal of voice : official journal of the Voice Foundation · 2025Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors.
Funding
Abstract
backgroundRecurrent respiratory papillomatosis (RRP) is a rare debilitating condition caused by chronic infection with human papillomavirus (HPV) type 6 or 11. Papillomas develop in the aerodigestive tract, leading to significant voice disturbance and airway obstruction. No systemic treatment currently exists. We aimed to assess the safety and clinical activity of PRGN-2012 in adult patients with RRP treated at the recommended phase 2 dose.
methodsThis was a single-centre, single-arm, phase 1/2 trial. Adult patients aged 18 years or older with RRP who required three or more interventions in the 1 year before treatment received adjuvant PRGN-2012 on day 1 following surgical debulking of disease, and on days 15, 43, and 85. Primary outcome measure was complete response rate, defined as the percentage of patients who did not require an intervention to control RRP in the 12 months after treatment. Safety outcomes included treatment-related adverse events. This study is registered ClinicalTrials.gov (NCT04724980).
findingsFrom March 16, 2021, to June 1, 2023, 38 patients were enrolled and received the 12-week treatment course. Among the 35 patients treated at the recommended phase 2 dose of 5×10
interpretationPRGN-2012 treatment resulted in complete response in 51% of the patients treated and was safe. Based on these positive pivotal study results, a biologics license application to the US Food and Drug Administration (FDA) is planned, positioning PRGN-2012 to be an FDA-approved medical treatment for adult patients with RRP.
fundingNational Institutes of Health.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.