-- Company Completes Enrollment in First Cohort --
SAN DIEGO, CA, Oct. 18 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation (TSX:NVN) today announced that the Company 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
|SOURCE Nventa Biopharmaceuticals Corporation|
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