PhotoCure ASA to Present Positive Data from Phase 2b Trial with Cevira

PhotoCure ASA announced that initial three-month data from the Phase 2b trial with Cevira in patients with human papilloma virus (HPV) related disease of the cervix, will be presented on March 11, 2013 at the Society of Gynecologic Oncology's 44th Annual Meeting on Women's Cancer, in Los Angeles, California. The abstract is entitled: A double-blind randomized placebo-controlled trial of hexaminolevulinate (HAL) photodynamic therapy in patients with cervical intraepithelial neoplasia (CIN) 1&2. Initial three month results from the phase 2b study show that the optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01). This was further supported by clearance of HPV, including subtypes 16 and 18 which carry high oncogenic risk. The clinical benefit was underlined by a high patient acceptance with only minor local self-limiting adverse reactions. Photocure will announce final results which include six-month follow up data in the second quarter of 2013.