Nventa Evaluation Complete for First Three Cohorts in HspE7 Phase 1 Cervical Dyspl...( - HspE7 Well Tolerated; Fourt...),Health

- HspE7 Well Tolerated; Fourth Cohort to be Dosed Shortly -

SAN DIEGO, March 3 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation (TSX: NVN) today announced the completion of the safety and tolerability assessment of its third cohort of patients in a Phase 1 clinical trial of new HspE7 (HspE7 + Poly-ICLC) in patients with cervical intraepithelial neoplasia (CIN). The safety data from the cohort were normal and met the limits prescribed in the trial protocol, allowing advancement to the fourth cohort of patients in the study.

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The evaluation by the Safety Review Committee was performed after the third cohort reached five weeks of treatment (two doses plus one week of follow-up). The dosing of the fourth cohort of patients is expected shortly.

At the end of each cohort, Nventa is also collecting immunological data that may provide an early indication of potential efficacy of the compound. All patients are being typed for class I and II human leukocyte antigen (HLA) subtypes, and are being evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.

The trial is expected to dose up to 5 cohorts comprising twenty-four patients. The first cohort of patients was administered 500 mcg of HspE7 and 50 mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist. The second cohort was administered 500 mcg of HspE7 and an escalated dose of 500 mcg of adjuvant. The third cohort was administered 500 mcg of HspE7 and 1,000 mcg of adjuvant. The fourth cohort will be administered 500 mcg of HspE7 and 2,000 mcg of adjuvant. An additional cohort of 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 th
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