Oslo, Norway, November 6, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announced today that data will be presented on Cevira, Photocure’s unique, non-invasive therapy for the treatment of oncogenic human papillomavirus (HPV) and pre-cancerous cervical abnormalities at the EUROGIN Congress in Florence, Italy on Wednesday 6th November. EUROGIN is the premier international organization focusing on current scientific developments in the field of cervical cancer and HPV related diseases.
Professor Peter Hillemanns, Head of Department of Gynecology and Obstetrics at the Medical University of Hannover, Germany will be presenting data on a placebo-controlled Phase IIb study of Cevira (hexaminolevulinate) photodynamic therapy in patients with CIN1 and CIN2 in the Advanced topics on colposcopy and treatment clinical session on Wednesday 6th November from 12.45pm to 14.30pm.
The Phase IIb trial was carried out in 262 patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2) and 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 the highest risk oncogenic HPV subtypes 16 and 18 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. Patients experienced only expected and self-limiting local events.
Oncogenic HPV infection is the most common sexually transmitted disease causing approx. 500,000 new cases of cervical cancer annually world-wide. CIN1 is a mild, low-grade lesion caused by persistent oncogenic HPV infections. High-grade lesions - CIN2, CIN3, or CIN2/3 - are more severe precancerous abnormalities that have a higher likelihood of progressing to cancer if left untreated. Standard treatment for CIN2/3 is surgical intervention which negatively impacts the function of the cervix leading to an increased risk of miscarriages and preterm births.
Professor Peter Hillemanns, commented on the results: “These data are encouraging and demonstrate that Cevira may become a novel, easy to use and safe tissue preserving treatment with sustained efficacy in CIN2 precancerous lesions and high risk oncogenic HPV infections. These results show that Cevira has the potential to be the first non-surgical alternative for the treatment of patients with HPV and precancerous lesions of the cervix. There is a high medical need for new non-invasive treatments in patients with high risk oncogenic HPV infections and precancerous lesions of the cervix, in whom current treatment options are limited to tedious watchful waiting and surgical procedures with a high degree of associated morbidity.”
Kjetil Hestdal, President and CEO of Photocure, said: “These encouraging Phase IIb data demonstrate the potential of Cevira as a promising new treatment option for the large number of women globally who suffer from HPV infections and related precancerous lesions of the cervix. These results support our ongoing partnership discussions for the further development and commercialization of Cevira.”
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 450 55 000, Email: email@example.com
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44 20 3440 5653, Email: firstname.lastname@example.org