Positive US phase III trial results for actinic keratosis


PhotoCure ASA has recently completed a phase III clinical trial in USA with Metvix® where more than 400 pre-cancerous skin lesions caused by sun damage (actinic keratosis (AK) or “sun spots”) were treated.

Photodynamic therapy (PDT) involves application of a cream, Metvix®, which is activated by red light (CureLight), so that the pre-cancerous sun spots are selectively destroyed, leaving the normal skin to heal without scars or blemishes.

The study showed that Metvix® PDT completely removed 88% of the lesions. The cosmetic outcome in the areas that were treated with Metvix® PDT was judged excellent by the investigators in 91% of the patients. In addition, a clear majority (73%) of the patients preferred Metvix® PDT to other treatment options.

“These results in AK confirm positive results shown previously in phase III studies with Metvix® in Europe and Australia. With the results from this US phase III study, PhotoCure’s clinical program for global registration of Metvix® for pre-cancerous AK is completed,” said Vidar Hansson, CEO of PhotoCure.

For more information contact:

PhotoCure ASA
Attn. Vidar Hansson, CEO
Hoffsveien 48
0377 Oslo
Norway

www.photocure.com
E-mail: vh@photocure.no
Telephone: +47 22 06 22 10
Fax: +47 22 06 22 18

PhotoCure ASA is a Norwegian listed company founded in 1993. PhotoCure ASA’s mission is to develop and sell pharmaceuticals and medical devices based on proprietary photodynamic technologies. The company is developing products for skin cancer and other skin diseases, internal cancer, gene therapy and cancer vaccines. PhotoCure has filed two applications for European marketing approval for its first pharmaceutical product, Metvix®, for treatment of non-melanoma skin cancer (Basal cell carcinoma not suitable for traditional therapy) and pre-cancerous skin lesions (actinic keratosis) respectively. PhotoCure’s second pharmaceutical product, Hexvix®, is currently in clinical phase II for bladder cancer detection.