PhotoCure ASA presents positive results of multinational clinical studies (phase III) of Metvix(r) photodynamic therapy for sun-damaged skin (actinic keratosis)

At a meeting in Munich on March 18th, PhotoCure ASA presented results of recently completed multinational phase III clinical studies. In the audience were leading dermatologists from Germany, Switzerland, Austria, Italy and the Netherlands who have taken part in the clinical development of PhotoCure's new therapy for sun-damaged skin (actinic keratosis, AK, a pre-cancerous skin lesion). Through their research, the efficacy and usefulness of photodynamic therapy (PDT) using Metvix(R) cream has now been demonstrated.

In one double-blind study half of the patients were treated with a placebo (inactive) cream, and the other half were treated with Metvix(R). The results show very clearly that Metvixâ is superior to the inactive cream, thereby establishing that Metvixâ PDT is an efficacious treatment for actinic keratosis.

Another phase III study compared Metvix(R) PDT to the current standard treatment, cryotherapy (freezing of the lesions). The two treatments gave similar results in terms of removing the lesions, but Metvixâ PDT resulted in superior cosmetic outcome, judged both by the doctors and by the patients themselves. Patient satisfaction was very high, and a large majority of patients who had previously undergone other treatments for AK preferred Metvix(R) PDT. These results show that Metvix(R) PDT is a good treatment option compared to current standard therapy.

The dermatologists who participated in the trials were impressed with the final results, and the future clinical potential of Metvix(R) PDT was eagerly discussed. Professor Lasse Braathen, who lead the group that worked on the study comparing Metvix(R) PDT to cryotherapy, said that because the cosmetic aspects in the treatment of sun-damaged skin are becoming increasingly important, Metvix(R) PDT represents a significant advance in this field.

These studies complete the formal documentation of Metvix(R) PDT for use in AK, and PhotoCure ASA expects to finalise the dossier for Market Authorisation Application submission in Europe within the next two months.