BioWorld International Correspondent
LONDON - PhotoCure ASA said 90 percent of all skin cancer lesions were cured within three months in a Phase III trial of Metvix, a topical photodynamic therapy (PDT). The study, in basal cell carcinoma (BCC), involved 120 patients in 13 centers.
"We were very pleased to see such good results," Geir Christian Melen, chief financial officer of the Oslo, Norway, company told BioWorld International. "Although the product has been used for some time by local [clinical] collaborators, it is good to get such results in a multicenter study. They show high efficacy combined with a good cosmetic outcome."
PhotoCure applied in May 2000 for registration of Metvix in the treatment of actinic keratosis, a precancerous skin lesion, and expects approval in this indication in Sweden in the second half of 2001. It will now apply to extend the labeling to BCC, a locally invasive, slowly spreading tumor arising from the basal cell layer of the epidermis.
There already are registered PDT treatments for actinic keratosis. Melen said Metvix has superior selectivity for cancer cells in the skin, and, as a lipophilic compound, is able to penetrate into the basal layer of the epidermis.
There are over 1.7 million cases of BCC in Europe, the U.S. and Australia each year, and in common with other forms of skin cancer, the incidence is increasing.
Further Phase III trials of Metvix in BCC are taking place for registration in the U.S. and Australia. PhotoCure will market Metvix in the Nordic countries of Europe, and is in discussions to find a partner or partners elsewhere. The company has developed the light source itself and sees the product being used in both hospital outpatient and doctor's office settings.
PhotoCure has a second product, Hexvix, in Phase II trials for the detection of bladder cancer. It also is developing its lipids for gene delivery and in chemotherapy.