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Nventa Announces Presentation of Positive HspE7 Data from,NCI-Sponsored Clinical Trial in Cervical Dysplasia

dging trial by mid-2007, pending submission of the final sections of an amendment to our original HspE7 Investigational New Drug application to the U.S. Food and Drug Administration."

Trial Design

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The trial presented today was a single-arm, open-label, Phase II study to establish the response rate and safety profile of HspE7 in women with biopsy-proven CIN III. The secondary aim was to correlate clinical responses to HspE7 vaccination in women infected with HPV 16 compared to women infected with other HPV types. Responses to HspE7 were determined by pathology of post-vaccination Loop Electrosurgical Excision Procedure (LEEP) specimens. (LEEP is a standard procedure for patients with high grade dysplasia to remove the affected areas.) A pathologic complete response (pCR) was defined as a specimen negative for CIN. A partial response (PR) was determined by a 50 percent or more reduction of lesion size post-vaccination.

Trial Results

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71 patients were registered, of whom 62 were eligible after screening. 58 patients completed the trial and were evaluable (31 in cohort 1, 27 in cohort 2). There were no significant HPV type differences between the 2 cohorts so responses were combined for analysis. Of the 58 patients, 13 (22.5 percent) had a pCR; 32 (55 percent) had a PR and 11 (19 percent) had stable disease. Two (3.5 percent) patients in cohort 2 had microinvasive disease and were defined as progressive disease. The overall response rate was 45/58 (78 percent). 33/58 (57 percent) of the patients were infected with HPV 16 prior to vaccination or in subsequent visits. There was no significant difference in regression in women infected with HPV 16 compared to those without HPV 16 infection (88 percent vs. 70 percent; p=0.12). Similar responses were seen in patients infected with multiple HPV types compared to those infected with one type (p=0.20). HspE7 showed efficacy in patients infected with HPV types o
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