Metvix® Photodynamic Therapy (PDT) Superior to Cryotherapy in the treatment of Actinic Keratosis (AK)

PhotoCure ASA has recently completed a large scale phase III clinical trial in Australia, where more than 800 pre-cancerous skin lesions (actinic keratosis or “sun spots”) caused by sun damage, in over 200 patients were studied. A novel photodynamic therapy, was compared to the most common traditional treatment, cryotherapy (freezing). Photodynamic therapy (PDT) involves application of a cream, Metvix®, which is activated by light (CureLight), so that the “sun spots” are selectively destroyed, leaving the normal skin to heal without scars or blemishes.

91% of the lesions were completely cured in patients treated with Metvix®Ò PDT. In contrast, only 68% of the lesions treated with cryotherapy were completely cured. The cosmetic outcome in the areas that were treated with Metvix® PDT was much better than in the areas treated by cryotherapy. Particularly, the occurrence of hypopigmentation (white spots on the skin) was less frequent in the Metvix® PDT group. In addition, a clear majority of the patients preferred Metvix® PDT to other treatment options.

Dr. Peter Foley of St. Vincent’s Hospital in Melbourne, who was the lead investigator for this study, said, “These results suggest that PDT is an effective, well tolerated and cosmetically acceptable therapy for a very common problem. At the very least it will provide an alternative to the currently available therapeutic options.”

In Australia, up to 50% of the population who are over 40 have at least one “sun spot”, and most have more than one(*1). Worldwide, it is estimated that about 20 million cases of actinic keratosis occur each year. Although the rate of transformation from “sun spot” to skin cancer is low, many skin specialists consider these lesions to be early forms of cancer which should be treated accordingly(*2).

Vidar Hansson, CEO of PhotoCure was pleased to comment, “With these results, the documentation required for submission of an application for marketing authorization (MAA) in Australia is now complete”.

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 completed final registration studies (phase III) with its first products, Metvix® and Curelight for actinic keratosis (pre-cancerous skin lesion), and filed its first application for European marketing approval in May 2000. Pivotal clinical trials for basal cell carcinoma (BCC) are ongoing and an application for marketing approval for BCC unsuitable for standard therapy will be filed 1st quarter 2001. PhotoCure's second pharmaceutical product, Hexvix™, is currently in clinical phase II for bladder cancer detection.