Nventa Initiates Phase 1 HspE7 Safety Trial
Nventa Biopharmaceuticals Corporation has completed enrollment and initiated dosing of the second cohort of patients in its Phase 1 dose escalation trial examining the safety of its lead candidate, HspE7, in patients with cervical dysplasia, a precursor to cervical cancer. HspE7 is an investigational therapeutic vaccine targeting human papillomavirus (HPV)-related diseases. Patients in this cohort have received the first of three immunizations of 500 mcg of HspE7 with 500 mcg of adjuvant.
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.
"We are very pleased that patient enrollment in this study has accelerated," said Peter Emtage, Ph.D., Vice President of Research and Development at Nventa. "We believe this is in recognition of the enthusiasm and support from participating clinical trial sites. With the majority of all study participants in the queue, we expect continued progress with enrollment in this Phase 1 study."
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.
The trial is expected to dose up to 5 cohorts totaling 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.
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.