Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Nventa Biopharmaceuticals has completed analysis of immunological data from all four cohorts of its Phase I clinical trial for HspE7, its lead product candidate for treatment of patients with cervical intraepithelial neoplasia or CIN, a precursor to cervical cancer.
Subscribe to our email newsletter
The purpose of the Phase I trial was to determine the safety, tolerability and immunogenicity of HspE7 plus escalating doses of adjuvant (50, 500, 1,000 and 2,000mcg of Poly-ICLC). All dose regimens were found to be safe and well tolerated. Immunogenicity analysis demonstrated that the adjuvant potently enhanced HPV16 E7-specific T-cell responses in subjects who demonstrated no or low responses at baseline.
Based on an analysis of HPV16 E7-specific T-cell responses across all cohorts, Nventa has identified a dose regimen of 500mcg of HspE7 and 1,000-2,000mcg of Poly-ICLC, a toll-like receptor 3 (TLR3) adjuvant, for subsequent Phase II trials.
Nventa has finalized its protocol for a multi-center, randomized, double-blind, placebo-controlled Phase II trial of HspE7 in patients with high-grade cervical dysplasia (CIN 2/3). Preparations have been made at approximately 40 clinical investigational sites in the US, Canada and Latin America.
The company has also designed a Phase II trial of HspE7 in patients with low-grade cervical dysplasia (CIN 1). The company intends to initiate one or both of these Phase II trials once it has secured necessary financing.