SAN DIEGO, CA, Sept. 10 /PRNewswire-FirstCall/ - Nventa BiopharmaceuticalsCorporation (TSX:NVN) today announced the initiation of its Phase 1 clinicaltrial to assess the safety and tolerability of new HspE7 (HspE7 dosed with anadjuvant) in 24 patients with cervical intraepithelial neoplasia (CIN). Inaddition to the key objective of assessing safety and tolerability, asecondary objective of the study is to assess T-cell and B-cell specific humanpapillomavirus (HPV)-E7 immune responses.
"Advancing our lead therapeutic vaccine program back into human clinicaltrials represents a major milestone for Nventa," said Peter Emtage, Ph.D.,Vice President, Research and Development at Nventa. "Based on the impressivepreclinical data collected to date using HspE7 combined with multipleadjuvants, we expect this trial to produce invaluable safety, tolerability andimmunological biomarker data of new HspE7 for use in designing future efficacytrials."
Following successful completion of this Phase 1 trial, the Companyanticipates launching a Phase 2 clinical trial with new HspE7 in patients withhigh-grade cervical intraepithelial neoplasia (CIN 2/3). The Company is alsoin discussions with clinical investigators regarding the design andimplementation of a second Phase 2 trial with new HspE7 in patients that areHIV-positive with low-grade CIN.
HspE7 + Adjuvant Phase 1 Trial Design:
The trial is a multicenter, nonrandomized, open-label Phase 1 safetystudy. The safety and tolerability of HspE7 and adjuvant administeredconcomitantly will be assessed following subcutaneous doses of HspE7 (500mcg/dose) plus graduated doses of adjuvant in patients with CIN. An additionalcohort administered a higher dose of HspE7 may be implemented if deemedappropriate by data from previous cohorts. Patients will be immunized every 28days for a period of 8 weeks (3 administrations). Post-treatment evaluationswill begin four weeks after the last of the three injections. Patientsenrolled with high-grade CIN (CIN 2/3) disease will be eligible to undergoclinically appropriate treatment of the cervix at the twelfth week of thestudy.
Nventa will also collect immunological data from these patients that mayprovide an early indication of potential efficacy of the compound. Todetermine if HspE7 plus adjuvant elicit T-cell and B-cell specific HPV-E7immune responses, all patients will be typed for class I and II humanleukocyte antigen (HLA) subtypes, and will be evaluated for cytokineresponses, anti-HspE7 antibodies and cellular (T-cell) immunology.
Nventa will hold a conference call on Thursday, September, 13, 2007, at9:00 am Eastern Time (6:00 am Pacific Time) to allow securities analysts andshareholders the opportunity to hear Management discuss an update on theprogress with HspE7 and other important milestones.
HspE7 is a novel therapeutic vaccine candidate for the treatment ofdiseases caused by the human papillomavirus (HPV), one of the most commonsexually transmitted diseases in the world. HspE7 is derived from Nventa'sproprietary CoVal(TM) fusion platform, which uses recombinant DNA technologyto covalently fuse stress proteins to target antigens, thereby stimulatingcellular immune system responses. Heat shock proteins (Hsps), also known asstress proteins, are naturally present in the human body and play importantroles in the immune system, including transporting substances within cells andactivating cells of the immune system. Nventa is pursuing clinical developmentof HspE7 in combination with an adjuvant.
About Nventa Corporation:
Nventa is developing innovative therapeutics for the treatment of viralinfections and cancer, with a focus on diseases caused by the humanpapillomavirus (HPV). The corporation is p