Oslo, Norway, December 5, 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the initial three month 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 statistically significant efficacy in eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients.
The phase 2b trial is 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 histology, cytology and HPV DNA as well as safety, was assessed three months after the last treatment. Results after the six-nine month assessment will be presented in the first half 2013.
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 significant clearance of HPV types 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83% vs 0%,(p<0.02). In the overall CIN1 and CIN2 study population, Cevira, at the optimal dose, showed a higher response (73% vs 60%, p=0.2) and clearance of high oncogenic risk in HPV types 16 and 18 (54% vs 11%, p=0.07) as compared to placebo.
Cevira was well tolerated and easy to use by both the gynecologists and patients. No treatment related serious adverse events were reported in the study. No patients withdrew from the study due to treatment related events. In addition, patients experienced only expected benign and self-limiting events.
Principal investigator, Professor Peter Hillemans, Head of Department of Gynecology and Obstetric at Medical Institute of University of Hannover, Germany: “These data are encouraging as they demonstrate that Cevira is a novel, easy to use and safe tissue preserving treatment that has the potential to be the first non surgical alternative for the treatment of patients with precancerous lesions of the cervix. There is a high medical need for non-invasive treatments in patients with high risk oncogenic HPV infections and precancerous lesions of the cervix in whom the 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 positive results with our new integrated drug-device represent a significant milestone as the results confirm our previous positive clinical experience with Cevira. These initial results support the ongoing partnership discussions for the further development and commercialization 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. We are looking forward to having the final results including long term follow up in the first half next year.”
Photocure will host an audio webcast at 15.00 CET / 14.00 GMT / 09.00 EST to present the results on 5 December 2012.
You can access the presentation on this link: http://webtv.hegnar.no/webcast.php?id=86605
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: email@example.com
CFO Erik Dahl
Tel: +47 50 55 000, Email: firstname.lastname@example.org
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: email@example.com
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.