Photocure ASA - Cevira Study completes study enrolment on time
Cevira study completes study enrolment on time
First study to evaluate optimal dose of novel integrated drug-delivery device. First novel therapeutic treatment option for highly prevalent cervical human papillomavirus (HPV) infections and precancerous lesions
Oslo, Norway, January 3, 2012:
Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, has completed patient enrolment in the phase IIb dose-finding study for Cevira - the first trial to evaluate the optimal dose of the novel integrated intravaginal drug-delivery device.
The study is a randomized, double blind placebo controlled trial in patients with low to moderate grade cervical intraepithelial neoplasia (CIN1-2). Patients receive 1-2 treatments using a novel drug-device combination. Primary treatment response will be evaluated by central review of histology, cytology and HPV assessments 3 months after treatment with follow-up of 9 months. Twenty-three centres in Europe and US have recruited a total of 240 patients to this study. The first results are anticipated in second half 2012 and will support the design of the pivotal phase III registration program for the USA and Europe.
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 gynaecologists, 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.
Kjetil Hestdal, President and CEO, states "We are delighted to see that patient recruitment has been able to meet our aggressive time line, underlining the large interest in solving an unmet medical need in this population".
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, E-mail: kh@photocure.no
M: Communications
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, E-mail: photocure@mcomgroup.com
About Photocure ASA
Photocure ASA is a worldwide leader in photodynamic technology. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure is focused on photodynamic technologies in dermatology and cancer. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology(TM). Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure's bladder cancer diagnostic product, Cysview/Hexvix is approved in Europe and the US. In addition, the company markets Allumera®, a photodynamic cosmetic in the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology(TM) is continuously being tested for new products and applications in cancer and dermatology.
Allumera®, Photocure® and Cysview(TM)/Hexvix® are registered trademarks of Photocure ASA. For more information about Photocure, visit www.photocure.com.