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news.Nventa Biopharmaceuticals has reported positive final results from a Phase II clinical trial testing HspE7, its lead therapeutic vaccine for human papillomavirus (HPV)-related diseases.
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The study was designed to determine the effects of vaccination with HspE7 in women with high-grade cervical intraepithelial neoplasia (CIN II/III), a precursor to cervical cancer.
The results of the trial showed that 95% of the patients had disease regression or their disease remained stable. Seven of 20 women (35%) had complete regression of their CIN II/III, one (5%) had regression to low-grade CIN (CIN I), 11 (55%) had stable disease and one (5%) had progression due to enlargement of her lesion.
Immune responses were seen in 9 of the 17 (53%) women tested; 5 of the 7 (71%) complete responders had an immune response. Only 5 of 21 (23%) of the women had HPV-16 or -18 subtypes, suggesting that vaccination with HspE7 elicits cross-reactivity.
“HspE7, at this dose and schedule, clearly induced lesion regression in a substantial portion of women with high-grade cervical intraepithelial neoplasia,” said Jeffrey Weber, professor of interdisciplinary oncology at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. “The fact that regression was correlated with immune response suggests that enhancing the immunological effects of this vaccine may lead to improvement in the rate of lesion eradication.”