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news.Nventa Biopharmaceuticals has completed enrollment and initiated dosing of the second cohort of patients in its Phase I dose escalation trial examining the safety of its lead candidate, HspE7, in patients with cervical dysplasia, a precursor to cervical cancer.
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In addition to safety and tolerability assessment, Nventa will also collect immunological data from these patients at the end of each cohort that may provide an early indication of potential efficacy of the compound. All patients will be typed for class I and II human leukocyte antigen (HLA) subtypes, and will be evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.
The trial is expected to dose up to 5 cohorts totaling twenty-four patients. Four cohorts will be administered 500 mcg of HspE7 and doses of 50, 500, 1,000, or 2,000 mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist. An additional cohort of six patients administered 1,000 mcg of HspE7 and 2,000 mcg of adjuvant may be added if deemed appropriate based on data from the previous four cohorts.
Following successful completion of this Phase I trial, the Company anticipates launching a Phase II clinical trial with new HspE7 in patients with high-grade cervical intraepithelial neoplasia (CIN 2/3). The company is also in discussions with clinical investigators regarding the design and implementation of a second Phase II trial with new HspE7 in patients that are HIV-positive with low-grade CIN.
Peter Emtage, vice president of research and development at Nventa,said: “With the majority of all study participants in the queue, we expect continued progress with enrollment in this Phase I study.”