Oslo, Norway, April 10, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces positive final results of the phase 2b study of Cevira in patients with human papilloma virus (HPV) related disease of the cervix. 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.
HPV is the most common sexually transmitted disease causing approx. 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.
Principal investigator, Professor Peter Hillemanns, Head of Department of Gynecology and Obstetrics at the Medical University of Hannover, Germany: “These data are encouraging and confirm the initial three month results, demonstrating that Cevira is 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 results 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. The ease of use and high patient and gynecologist acceptance will allow the novel technology to be used widely around the world. These results support our ongoing partnership discussions for the further development and commercialization of Cevira.”
The phase 2b trial was a multicenter, randomized, double-blind placebo controlled trial in patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2). The study enrolled 262 patients at 23 office or hospital based gynecology practices in the US and Europe. Patients were randomized to three different doses of hexylaminolevulinate to evaluate the optimal dose as compared to placebo. The treatment regimen consisted of up to two treatments, each three months apart. Efficacy, measured by cytology and HPV DNA, with or without histology, as well as safety, was assessed at three and six months after the last treatment.
PRESENTATION AND WEBCAST
In connection with the release of these results Photocure will host a presentation and webcast at 15.00 CET / 14.00 BST / 09.00 EST on April 11, 2013 at Hotel Continental, Oslo.
At this presentation Professor Ole Erik Iversen from the Department of Obstetrics and Gynecology at Haukeland University Hospital, Bergen Norway and Principal investigator, Professor Peter Hillemanns, Head of Department of Gynecology and Obstetrics at the University of Hannover, Germany will present current views on HPV related disease of cervix and the results from the Cevira phase 2b study.
You can access the webcast at: http://webtv.hegnar.no/webcast.php?id=98856
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 50 55 000, Email: email@example.com
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: firstname.lastname@example.org
Notes to editors
Cervical HPV and precancerous lesions of the cervix are highly prevalent diseases affecting an estimated 260 million women across the globe, currently with no therapeutic treatment options 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, obviating the potential morbidities associated with surgery. Clinical proof of concept has previously been demonstrated, with an excellent safety profile and no patient down time.