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Nventa Enrolls and Initiates Dosing of Final Cohort in HspE7 Phase 1 Cervical Dysplasia Trial
Date:3/11/2008

SAN DIEGO, March 11 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation (TSX: NVN) today announced that the Company has completed enrollment and initiated dosing of the fourth and final cohort of patients in its Phase 1 dose escalation trial. This study examines the safety of its lead candidate, new HspE7 (HspE7 + Poly-ICLC, a toll-like receptor-3, or TLR3 agonist), in patients with cervical intraepithelial neoplasia, or CIN, a precursor to cervical cancer. New HspE7 is an investigational therapeutic vaccine targeting human papillomavirus (HPV)-related diseases.

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"Conclusion of enrollment in this study is a significant milestone for Nventa," said Gregory M. McKee, President and Chief Executive Officer at Nventa. "We have spent considerable time analyzing the need for a fifth cohort in this study, and have determined that the fourth cohort dose level is likely optimal for future clinical trials. Following completion of this Phase 1 study, we anticipate launching a comprehensive Phase 2 program studying the safety and efficacy of new HspE7 in patients with CIN."

When complete, the Phase 1 trial will have dosed four cohorts totaling seventeen patients with a fixed dose of 500 mcg of HspE7 and either 50, 500, 1,000 or 2,000 mcg of the adjuvant, Poly-ICLC. In addition to safety data, immunological data are being collected pre-treatment, following each dose of new HspE7, and at the end of the study from all patients, which could provide an early indication of potential activity of new HspE7. All patients are also 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.

Affiliations and investigators in this trial currently have included the Montefiore Medical Center
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SOURCE Nventa Biopharmaceuticals Corporation
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