Oslo, Norway, 15 July– Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, has initiated enrolment in a large phase II trial in USA to confirm the safety and efficacy of Visonac. Together with previous phase II studies this trial lays the foundation for the pivotal, phase III program.
The study is a randomized, placebo controlled study in patients with moderate to severe acne vulgaris. The trial will enroll 150 patients, at 12 centers, across the US. The study will measure safety and efficacy in patients aged 12 – 35 years with moderate to severe acne after four treatments with a convenient office based procedure as compared to light alone. Results of the trial are anticipated in the second half 2012.
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 better tolerated alternative than isotretinoin, Visonac has the potential to satisfy a high unmet medical need.
Kjetil Hestdal, President and CEO, states “There is a large unmet medical need for a better tolerated treatment alternative for acne. This trial will serve to confirm the positive results obtained in a previous multicenter Phase II study with Visonac in a broader patient population and position us to proceed into our phase III pivotal program in 2013.”
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Christian Fekete
Tel: + 47 916 42 938, Email: email@example.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™. 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, Hexvix® is approved in the European Union 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™ is continuously being tested for new products and applications in cancer and dermatology.
Allumera™, Visonac®, Cevira® and Lumacan®, Photocure® and Hexvix® are registered trademarks of Photocure ASA. For more information about Photocure, visit our website at www.photocure.com