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 .
This information is subject of the disclosure requirements
acc. to §5-12 vphl (Norwegian Securities Trading Act)
distribué par | Ce noodl a été diffusé par Photocure ASA et initialement mise en ligne sur le site http://www.photocure.com. La version originale est disponible ici. Ce noodl a été distribué par noodls dans son format d'origine et sans modification sur 2012-01-03 10:43:45 AM et restera accessible depuis ce lien permanent. Cette annonce est protégée par les règles du droit d'auteur et toute autre loi applicable, et son propriétaire est seul responsable de sa véracité et de son originalité. |