Biomaterial Database

Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy. 2011

Jean-Luc Brun, and Véronique Dalstein, and Jean Leveque, and Patrice Mathevet, and Patrick Raulic, and Jean-Jacques Baldauf, and Suzy Scholl, and Bernard Huynh, and Serge Douvier, and Didier Riethmuller, and Christine Clavel, and Philippe Birembaut, and Valérie Calenda, and Martine Baudin, and Jean-Paul Bory

Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Laboratory of Virology, University of Bordeaux, Bordeaux, France. jean-luc.brun@chu-bordeaux.fr

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.

UI	MeSH Term	Description	Entries
D007167	Immunotherapy	Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.	Immunotherapies
D002578	Uterine Cervical Dysplasia	Abnormal development of immature squamous EPITHELIAL CELLS of the UTERINE CERVIX, a term used to describe premalignant cytological changes in the cervical EPITHELIUM. These atypical cells do not penetrate the epithelial BASEMENT MEMBRANE.	Cervical Dysplasia,Cervical Intraepithelial Neoplasia,Cervix Dysplasia,Dysplasia of Cervix Uteri,Neoplasia, Cervical Intraepithelial,Cervical Intraepithelial Neoplasia, Grade III,Cervical Intraepithelial Neoplasms,Intraepithelial Neoplasia, Cervical,Cervical Dysplasia, Uterine,Cervical Dysplasias,Cervical Intraepithelial Neoplasm,Cervix Uteri Dysplasia,Cervix Uteri Dysplasias,Dysplasia, Cervical,Dysplasia, Cervix,Dysplasia, Uterine Cervical,Intraepithelial Neoplasm, Cervical,Intraepithelial Neoplasms, Cervical,Neoplasm, Cervical Intraepithelial,Neoplasms, Cervical Intraepithelial
D002583	Uterine Cervical Neoplasms	Tumors or cancer of the UTERINE CERVIX.	Cancer of Cervix,Cancer of the Cervix,Cancer of the Uterine Cervix,Cervical Cancer,Cervical Neoplasms,Cervix Cancer,Cervix Neoplasms,Neoplasms, Cervical,Neoplasms, Cervix,Uterine Cervical Cancer,Cancer, Cervical,Cancer, Cervix,Cancer, Uterine Cervical,Cervical Cancer, Uterine,Cervical Cancers,Cervical Neoplasm,Cervical Neoplasm, Uterine,Cervix Neoplasm,Neoplasm, Cervix,Neoplasm, Uterine Cervical,Uterine Cervical Cancers,Uterine Cervical Neoplasm
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014626	Vaginal Smears	Collection of pooled secretions of the posterior vaginal fornix for cytologic examination.	Cervical Smears,Cervical Smear,Smear, Cervical,Smear, Vaginal,Smears, Cervical,Smears, Vaginal,Vaginal Smear
D016896	Treatment Outcome	Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.	Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D019496	Cancer Vaccines	Vaccines or candidate vaccines designed to prevent or treat cancer. Vaccines are produced using the patient's own whole tumor cells as the source of antigens, or using tumor-specific antigens, often recombinantly produced.	Cancer Vaccine,Neoplasm Vaccines,Tumor Vaccine,Tumor Vaccines,Vaccines, Cancer,Vaccines, Neoplasm,Vaccines, Tumor,Vaccine, Cancer,Vaccine, Tumor