Abstracts

Activity of HspE7 in patients with anogenital warts

Abstract presented at American Society for Colon and Rectal Surgeons 2001 Annual Meeting  -  San Diego, CA  June 2-7, 2001 as printed in Dis Colon Rectum  2001  44(4): A5-A26

Goldstone SE(1), Palefsky JM(2), Winnett MT(3), Neefe JN(3)

(1) New York, NY
(2) San Francisco, CA
(3) Collegeville, PA

Purpose:  Human papillomavirus (HPV) causes anogenital squamous intraepithelial lesions (SIL), warts and cancer.  Treatment of SIL to prevent cancer often requires extensive surgery.  We tested an HPV-specific immunotherapy, HspE7, as a potential alternative. 

Methods: HspE7 was constructed by fusing heat shock protein Hsp65 from BCG to E7 protein from HPV16. Improvement in pathologic diagnosis of patients with persistent high grade SIL (HSL) was studied in an open label trial (HspE7 500 mcg monthly x3). Warts were not a study parameter, but a review of charts of patients enrolled at one study site (SEG) was undertaken to estimate the quality and frequency of responses of anogenital warts. Patients with warts by physical examination at baseline were scored at six months as to the % reduction in wart size.

Results: The first 22 patients enrolled at this site were reviewed. 14 of 22 patients had warts at baseline. Of these 14, at 6 months, 3 had complete resolution and 10 had warts reduced in size 70-95%. The remaining patient's warts increased in size. The reduction in size in most patients markedly diminished the procedure necessary for complete ablation. No serious or severe adverse events were related to HspE7. As reported elsewhere, 75% of patients had no HSIL at 6 months and this response was not HPV16 specific.

Conclusions: A retrospective chart review suggests that HspE7 is broadly active in anogenital warts as it is in anal HSIL. This activity crosses multiple HPV types. The warts improved substantially but usually did not disappear totally within six months. Follow-up continues. A new randomized trial will test these findings in rigorous fashion.