Photocure ASA - Photocure announces completion of Visonac® study enrolment
PHOTOCURE ANNOUNCES COMPLETION OF VISONAC® STUDY ENROLMENT
Novel photodynamic therapeutic treatment for acne
Oslo, Norway, January 13, 2012:
Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, has completed patient enrolment according to schedule in its Phase IIb study using Visonac, a novel topical acne treatment.
The Phase IIb trial is a randomized, double-blind, placebo controlled study in patients with moderate to severe acne vulgaris. It will measure safety and efficacy in patients aged 12 - 35 years, who will receive four treatments over a six week period. The cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light. Fifteen centres in the US have recruited a total of 150 patients to this study. The participants have been office based dermatology practices and hospitals. The results are anticipated in 3Q2012 and will support the design of the pivotal Phase III studies in the US and Europe.
Acne is the single most common skin disease worldwide, and affects up to 85% of all 12-24 year olds. There is a high unmet medical need for patients with moderate to severe acne, where the current mainstay of treatment is oral antibiotics and/or retinoids. Visonac is being developed as the first photodynamic therapeutic option for this large patient population, which can easily and conveniently be administered in dermatology offices. By avoiding the risks of increased antibiotic resistance from long term exposure, and providing a highly tolerable alternative to isotretinoin, Visonac has the potential to satisfy a high unmet medical need. Clinical proof of concept has previously been demonstrated with an excellent safety profile and minimal patient down time.
Kjetil Hestdal, President and CEO, said: "We are delighted to see that patient recruitment has been successfully completed in line with our aggressive time line. This highlights the interest from patients suffering from moderate to severe acne, and we expect data will continue to support the potential of Visonac as an effective alternative treatment to current therapies".
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
M: Communications
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: photocure@mcomgroup.com
About Visonac®
The Visonac® cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light. The mechanism of action appears to involve killing of bacteria as well as specific action on sebaceous glands and inflammatory cells.
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.
Visonac®, Allumera®, Photocure® and Cysview(TM)Hexvix® are registered trademarks of Photocure ASA. For more information about Photocure, visit www.photocure.com.