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PhotoCure ASA Announces Positive Final Results of Phase 2B Cevira Study


Wednesday, 10 Apr 2013 12:00pm EDT 

PhotoCure ASA announced positive final results of the phase 2b study of Cevira in patients with human papilloma virus (HPV) related disease of the cervix. Cevira, an integrated drug-delivery device, demonstrated significant and sustained efficacy in the eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients. HPV is the most common sexually transmitted disease causing approximately 500,000 cases of cervical cancer world-wide annually. CIN1 is mild, low-grade lesions caused by HPV infection. High-grade lesions - CIN2, CIN3, or CIN2/3 - are more severe abnormalities that have a higher likelihood of progressing to cancer if left untreated. The optimal dose of Cevira, 5%, demonstrated a statistically significant and sustained lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 62% respectively at six months, (p<0.02). This was further supported by high clearance of HPV subtypes 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83% vs 33% at six months. Additionally, high clearance of HPV 16 and 18 was also demonstrated in the overall CIN1/2 population, 62% vs. 33% as compared to placebo. Cevira was well tolerated and easy to use by both gynecologists and patients. No treatment related serious adverse events were reported in the study. Additionally, patients experienced only expected benign and self-limiting events. 

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