Clinical Trials Resource Center

New Medical Therapies™

Cervical Intraepithelial Neoplasia

August 4, 2014

Inovio Pharmaceuticals reported results of a randomized, double-blind, placebo-controlled phase II trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia 2/3 (CIN2/3) associated with human papilloma virus (HPV) types 16 or 18. Treatment was randomized 3:1 between the VGX-3100 and placebo groups, and was stratified by age and severity of CIN. Women in the active group received three 6 mg doses of VGX-3100 in a 1mL intramuscular injection followed by electroporation with Inovio’s CELLECTRA device at weeks zero, four and 12. Cervical tissue was examined before starting blinded treatment and nine months later. In the per protocol analysis, CIN2/3 resolved to CIN1 or no disease in 53 of 107 (49.5%) women treated with VGX-3100 compared to 11 of 36 (30.6%) who received placebo. This difference was statistically significant (p<0.025). Virological clearance of HPV 16 or 18 from the cervix in conjunction with histopathological regression of cervical dysplasia to CIN1 or no disease, a secondary endpoint of the trial, was observed in 43 of 107 (40.2%) VGX-3100 recipients compared to five of 35 (14.3%) placebo recipients (p<0.025). The treatment was generally well-tolerated, with only administration site redness occurring significantly more frequently in the VGX-3100 group compared to the placebo group in the seven and 28-day periods following treatment.

August 23, 2010

Advaxis issued positive interim results from a phase II trial of ADXS11-001 for cervical dysplasia. This single blind, placebo controlled, randomized comparison trial plans to enroll 120 female subjects with late stage cervical dysplasia requiring surgical intervention. The subjects received a three dose intravenous regimen of ADXS11-001 using 5x10(7), 3.3x10(8) or 1x10(9) colony forming units at 28 day intervals. At this time the three subjects in the low dose group had received all nine doses. No adverse events associated with the ADXS11-001 administration were observed.

March 31, 2008

Nventa released positive interim results from a phase I trial of HspE7 for the treatment of cervical intraepithelial neoplasia (CIN). This multi-center, nonrandomized, open-label study enrolled twenty four subjects who were placed in four cohorts. The reported data is from Cohort One, who received subcutaneous doses of 500 mcg of HspE7 and 50 mcg of adjuvant containing Poly-IC, and Cohort Two, who also received 500 mcg of HspE7 and 500 mcg of Poly-IC. The subjects were immunized every twenty-eight days for eight weeks. Four weeks after the last immunization, safety and tolerability as well as T-cell and B-cell specific human papillomavirus (HPV)-E7 immune responses were assessed. The cohort one dose level demonstrated anti-HspE7 antibody responses but limited T-cell responses. In cohort two, three out of four subjects showed anti-HspE7 antibody responses and HPV16 E7-specific T-cell responses. The doses administered in both study cohorts were found to be safe and well tolerated, with no serious adverse events being reported in either group. Based on the results, Nventa plans to commence a phase II study later in 2008.

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