Nventa Initiates HSPE7 Cervical Dysplasia Trial

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Nventa Biopharmaceuticals Corporation has completed enrollment and initiated dosing of the third 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 1,000 mcg of adjuvant.

"We are very pleased with the progress of this Phase 1 study," said Gregory M. McKee, President and Chief Executive Officer at Nventa. "We are also encouraged by the data collected and analyzed to date and look forward to utilizing the Phase 1 results in the design of our planned Phase 2 HspE7 trial."

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Immunological data from these patients will be collected at the end of each cohort. These data 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.

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.

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 comprising twenty-four patients. The first cohort of patients was administered 500 mcg of HspE7 and 50 mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist. The second cohort was administered 500 mcg of HspE7 and an escalated dose of 500 mcg of adjuvant. The third cohort was administered 500 mcg of HspE7 and 1,000 mcg of adjuvant, and the fourth cohort will be administered 500 mcg of HspE7 and 2,000 mcg of adjuvant. 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.

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