The evaluation by the safety review committee was performed once the first cohort reached five weeks of treatment (two doses plus one week of follow-up).
The safety data from new HspE7 were normal and met the limits prescribed in the trial protocol, thereby allowing progression to the second cohort of patients who will receive HspE7 with an escalated dose of adjuvant.
The trial is expected to dose up to five cohorts comprising 24 patients, with four cohorts administered 500mcg of HspE7 and doses of 50, 500, 1,000, or 2,000mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist. An additional cohort of six patients administered 1,000mcg of HspE7 and 2,000mcg of adjuvant may be added if deemed appropriate based on data from the previous four cohorts.
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 subtypes, and will be evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.