|
Nventa initiates HspE7 Phase 1 Cervical Dysplasia Trial |
|
|
|
11 Sep 2007 |
Nventa Biopharmaceuticals Corporation today announced the initiation of its Phase 1 clinical trial to assess the safety and tolerability of new HspE7 in 24 patients with cervical intraepithelial neoplasia (CIN)
SAN DIEGO, CA, USA | September 10, 2007 | 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 cohorts. Patients will be immunized every 28 days for a period of 8 weeks (3 administrations). Post-treatment evaluations will begin four weeks after the last of the three injections. Patients enrolled with high-grade CIN (CIN 2/3) disease will be eligible to undergo clinically appropriate treatment of the cervix at the twelfth week of the study.
Nventa will also collect immunological data from these patients that may provide an early indication of potential efficacy of the compound. To determine if HspE7 plus adjuvant elicit T-cell and B-cell specific HPV-E7 immune responses, 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.
About HspE7, Lead Product Candidate:
HspE7 is a novel therapeutic vaccine candidate for the treatment of diseases caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. HspE7 is derived from Nventa’s proprietary CoVal™ fusion platform, which uses recombinant DNA technology to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune system responses. Heat shock proteins (Hsps), also known as stress proteins, are naturally present in the human body and play important roles in the immune system, including transporting substances within cells and activating cells of the immune system. Nventa is pursuing clinical development of HspE7 in combination with an adjuvant.
About Nventa Biopharmaceuticals Corporation:
Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus (HPV). The corporation is publicly traded on the Toronto Stock Exchange under the symbol NVN. For more information about Nventa, please visit www.nventacorp.com.
SOURCE: NVENTA |
