PhotoCure - Long-term Phase III Study with Metvix® for BCC
PhotoCure ASA (OSE:PHO) has obtained the first results from its Phase III studies on more than 200 basal cell carcinoma patients that will continue over five years. After the first twelve-month period of the study, there were no significant differences between disease recurrence rates:
- For superficial BCC, there was an 8% recurrence rate with Metvix® PDT compared to 16% recurrence rate for cryotherapy.
- For nodular BCC, there was a 5% recurrence rate for Metvix® PDT compared to 0% for surgery.
Metvix® PDT also showed a significant improvement in cosmetic outcome when compared to the two other standard treatments.
A novel treatment, Metvix® photodynamic therapy involves the application of Metvix® cream to the skin where it is absorbed preferentially by cancer cells. The cream is subsequently activated by a PhotoCure's proprietary red light source.
The cosmetic outcome is important for patients with BCC on the face. At the initial 3-month assessment, the cosmetic outcome was much better following treatment with Metvix® PDT than after both of the standard treatments. At the 12-month stage, the difference between cosmetic outcomes had increased further. The dermatologists therefore graded the cosmetic outcome as "good" or "excellent" in 80% of the Metvix® PDT patients with nodular BCC compared to only 38% who had had surgery. In patients with superficial BCC, 89% of the Metvix® PDT patients were graded "good" or "excellent" compared to 62% of patients who had had cryotherapy treatment.
PhotoCure's President and CEO Professor Vidar Hansson commented: "We are very pleased with these results which confirm previously obtained data and the results will form an important part of the Metvix® PDT documentation".
Metvix® PDT was first approved in Sweden and recently also approved in 13 additional European countries and New Zealand, while applications are pending in Australia, Switzerland and the US. PhotoCure has licensed the rights to promote and sell Metvix® PDT outside the Nordic area to Galderma S.A.