- Conference Call on September 13 to Discuss Phase 1 Trial and Other Major
SAN DIEGO, CA, Sept. 10 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation (TSX:NVN) today announced the initiation of its Phase 1 clinical trial to assess the safety and tolerability of new HspE7 (HspE7 dosed with an adjuvant) in 24 patients with cervical intraepithelial neoplasia (CIN). In addition to the key objective of assessing safety and tolerability, a secondary objective of the study is to assess T-cell and B-cell specific human papillomavirus (HPV)-E7 immune responses.
"Advancing our lead therapeutic vaccine program back into human clinical trials represents a major milestone for Nventa," said Peter Emtage, Ph.D., Vice President, Research and Development at Nventa. "Based on the impressive preclinical data collected to date using HspE7 combined with multiple adjuvants, we expect this trial to produce invaluable safety, tolerability and immunological biomarker data of new HspE7 for use in designing future efficacy trials."
Following successful completion of this Phase 1 trial, the Company anticipates launching a Phase 2 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 2 trial with new HspE7 in patients that are HIV-positive with low-grade CIN.
HspE7 + Adjuvant Phase 1 Trial Design:
The trial is a multicenter, nonrandomized, open-label Phase 1 safety
study. The safety and tolerability of HspE7 and adjuvant administered
concomitantly will be assessed following subcutaneous doses of HspE7 (500
mcg/dose) plus graduated doses of adjuvant in patients with CIN. An
additional cohort administered a higher dose of HspE7 may be implemented if
deemed appropriate by data from previous co
|SOURCE Nventa Biopharmaceuticals Corporation|
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