title: Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy.
abstract: OBJECTIVE
  We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16-related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months.
  
  
  METHODS
  In all, 21 patients with HPV 16-related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy.
  
  
  RESULTS
  Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up.
  
  
  CONCLUSIONS
  These promising data warrant further development of TG4001 in CIN 2/3 treatment.
authors.affiliation: Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Laboratory of Virology, University of Bordeaux, Bordeaux, France. jean-luc.brun@chu-bordeaux.fr
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Brun
authors.forename: Véronique
authors.initials: V
authors.lastname: Dalstein
authors.forename: Jean
authors.initials: J
authors.lastname: Leveque
authors.forename: Patrice
authors.initials: P
authors.lastname: Mathevet
authors.forename: Patrick
authors.initials: P
authors.lastname: Raulic
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Baldauf
authors.forename: Suzy
authors.initials: S
authors.lastname: Scholl
authors.forename: Bernard
authors.initials: B
authors.lastname: Huynh
authors.forename: Serge
authors.initials: S
authors.lastname: Douvier
authors.forename: Didier
authors.initials: D
authors.lastname: Riethmuller
authors.forename: Christine
authors.initials: C
authors.lastname: Clavel
authors.forename: Philippe
authors.initials: P
authors.lastname: Birembaut
authors.forename: Valérie
authors.initials: V
authors.lastname: Calenda
authors.forename: Martine
authors.initials: M
authors.lastname: Baudin
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Bory
mesh_terms: D019496:Cancer Vaccines / Q000276:immunology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000276:immunology / Q000473:pathology / Q000628:therapy*
chemical_list: D019496:Cancer Vaccines; C556559:TG4001 vaccine