Nventa announces positive HspE7 data from NCI-sponsored clinical trial in HIV-positive patients

First Clinical Evidence that HspE7 May Have Activity in Immunocompromised Patients


Nventa Biopharmaceuticals Corporation announced results, recently published in the journal AIDS, from a clinical trial to test HspE7, an investigational therapeutic vaccine for human papillomavirus (HPV)-related diseases, on patients with high-grade anal intraepithelial neoplasia (AIN), or dysplasia, in HIV-positive individuals. The trial was conducted by the AIDS Malignancy Consortium at the University of California in San Francisco and was sponsored by the U.S. National Cancer Institute.

The Phase I/II trial tested HspE7 in three cohorts of five participants each assigned to receive variable doses of HspE7 through three injections at four-week intervals. Anal disease was assessed by pathology at 8, 12, 24 and 48 weeks, and 39 different types of HPV were measured, including types 16, 18 and 31. At 48 weeks, five of the fifteen participants in the trial (33 percent) responded to HspE7 and regressed to low-grade anal or no significant dysplasia. All participants had at least one oncogenic HPV type at baseline. Three of five (60 percent) of the participants who regressed to low-grade dysplasia or no significant dysplasia became HPV-negative, compared with none of the ten participants with no clinical response (p=0.02). Nventa is now working on a more potent version of HspE7 than was used in this trial.

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