Clinical Trials Resource Center

New Medical Therapies™

Cervical Dysplasia

September 20, 2010

Inovio reported positive results from a phase I trial of VGX-3100, a DNA vaccine to treat pre-cancerous cervical dysplasias and cancers caused by human papillomavirus (HPV) types 16 and 18. This US-based, open label, dose escalation study enrolled 18 female subjects previously treated for moderate or severe cervical intraepithelial neoplasia. The subjects received VGX-3100 0.6 mg, 2 mg or 6 mg delivered via electroporation. Each group received the respective dose at day 0, month one and month three. All dose groups developed significant antibody and T-cell immune responses; however the third and final dose group (6 mg) showed the strongest response. This cohort developed significant CTL responses, with average responses of 1362 SFU per million cells after three immunizations. This was a 118% increase compared to the intermediate dose cohort average of 626 SFU per million cells (four responders out of six) and a 174% increase compared to the low dose cohort average of 497 SFU per million cells (four responders out of six). Antibodies were also generated against all four antigens; in the third cohort antibody responses were observed in five of six subjects (83%). There were no vaccine-related serious adverse events.

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 28, 2005

Stressgen Biotechnologies reported positive results of a phase II trial of HspE7, for the treatment of high-grade cervical dysplasia. These results were announced at the Society of Gynecologic Oncologists Annual Meeting on Women's Cancer. Data indicated that the drug produced a complete pathologic response in 32% of patients (n=10), a partial response of greater-than-50% lesion regression in 39% of patients (n=12), and stable disease in 29% of patients (n=9). No patients receiving the drug experienced progressive disease. The drug was also observed to be well tolerated, with no serious adverse events and injection site reactions noted as the most frequent overall adverse event. This open-label study enrolled 31 women with confirmed cervical dysplasia, who received three subcutaneous injections of 500 mcg HspE7 over sixty-days, prior to all subjects undergoing a Loop Electrocautery Excision Procedure. The company announced that, based on these results, they planned to initiate additional trials of the drug to investigate whether complete pharmacologic response will allow patients to avoid surgical excision.

October 28, 2002

Lycos reported positive preliminary results of a phase IIb trial investigating ZYC101a in women with high-grade cervical dysplasia, caused by the human papilloma virus (HPV). The randomized, double blinded, placebo-controlled study of 161 women was conducted in 17 centers across the U.S. and in Europe. In a preselected cohort of younger subjects, high-grade cervical dysplasia was resolved in 70% treated with ZYC101a compared to only 23% of subjects treated with placebo. In the total population, high-grade cervical dysplasia was resolved in 43% of subjects treated with ZYC101a compared to 27% of subjects treated with placebo. The drug was shown to be safe and well tolerated.

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