Phase 2b results demonstrate significant and sustained efficacy in treating human papilloma virus and precancerous lesions of the cervix
Oslo, Norway, 4 November 2014: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the Phase 2b study of Cevira in patients with human papilloma virus (HPV) related disease of the cervix, has been published in the prestigious American Journal of Obstetrics and Gynecology.
Cevira, a novel and easy to use integrated drug-delivery device, demonstrated significant and sustained efficacy in the eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients as compared to placebo.
Kjetil Hestdal, President and CEO of Photocure, said: “There is a high unmet medical need for a therapeutic alternative for the large number of women globally who suffer from HPV infections. The easy to use technology, high patient and gynecologist acceptance will allow this treatment to be used widely. The publication of this data in such an esteemed journal is testament to the potential of Cevira as a promising new treatment option, and endorses our ongoing partnership discussions for Cevira’s development and commercialization.”
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, Head of Department of Gynecology and Obstetrics at the Medical University of Hannover, Germany and Principal Investigator, said: “The increased morbidity from surgical treatment of precancerous lesions of the cervix is well established. There is a need for well tolerated and convenient therapeutic alternatives. Cevira is a promising product as a potential treatment in the large group of women in need of cervix preserving treatments.”
The final study results were announced in April 2013. The Phase 2b trial was carried out in 262 patients with low to moderate grade cervical intraepithelial neoplasia (CIN1/2) caused by oncogenic Human papilloma virus (HPV) infections. It 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.
The publication, “A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia (CIN) 1/2" can be viewed at http://www.sciencedirect.com/science/article/pii/S0002937814021991
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
CFO Erik Dahl
Tel: +47 50 55 000, Email: ed@photocure.no
Hume Brophy
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44 20 3440 5653, Email: photocure@humebrophy.com
Notes to editors
About Photocure ASA
Photocure ASA, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology(TM) platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com
About Cevira®
Cervical HPV and precancerous lesions of the cervix are highly prevalent diseases affecting an estimated 260 million women worldwide. There is currently no medical therapeutic treatment option available. Cevira is being developed as the first novel therapeutic option for this large and growing patient population. Cevira can be easily administered by gynecologists, avoiding the potential morbidities associated with surgery.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)
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