Tigris Pharmaceuticals has launched a multicenter, double-blind Phase II clinical trial with A-007 in 250 patients with high-grade cervical intraepithelial neoplasia (CIN).
The primary objective of the study is to determine the pathological response of A-007, a self-administered intravaginal gel, as compared to placebo in the treatment of high-grade CIN. Secondary objectives are evaluation of safety, human papillomavirus (HPV) eradication assessed via polymerase chain reaction (PCR) and Hybrid Capture II, and measurement of immunologic parameters. The trial is being conducted at 25 research centers in the U.S. Results from the trial are expected to be available in 2007.