Nventa Starts Cervical Dysplasia Trial With New HspE7
Nventa Biopharmaceuticals Corporation has completed enrollment of the first cohort in its Phase 1 clinical trial to assess the safety and tolerability of new HspE7 in patients with cervical intraepithelial neoplasia (CIN).
The trial is expected to dose up to 5 cohorts comprising twenty-four patients. Four cohorts will be administered 500 mcg of HspE7 and doses of 50, 500, 1,000, or 2,000 mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist. An additional cohort of six 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.
In addition to safety and tolerability assessment, Nventa will also collect immunological data from these patients at the end of each cohort that may provide an early indication of potential efficacy of the compound. 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.
Affiliations and investigators in this trial currently include the Montefiore Medical Center; William D. Kolton, M.D. of San Diego, California; Linda Roman, M.D. of the University of Southern California (USC); Michael L. Twede, M.D. of the Salt Lake Women's Center in Sandy, Utah; and Mark T. Saunders, M.D. at the Mt. Timpanogos Women's Healthcare/Physician's Research in Pleasant Grove, Utah.
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 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.