Oslo, Norway, 2 April 2003.
PhotoCure announces that new clinical studies show good results with Metvix® PDT treatment of patients with early squamous cell carcinoma (SCC). Previous studies have shown high efficacy and excellent cosmetic outcome in the Metvix® PDT treatment of basal cell carcinoma (BCC) and actinic keratosis (AK). SCC is a more dangerous non-melanoma skin cancer than BCC and AK.
A large European multicentre phase III study, including 229 patients recruited by 41 dermatology centres in 10 European countries, examined the efficacy of Metvix® PDT in patients with early SCC (Mb. Bowens). Metvix® PDT was compared to placebo, cryotherapy or topical chemotherapy (5-FU). Compared to cryotherapy and 5-FU, Metvix® PDT showed better complete lesion response rate (93% vs. 86% and 83%) and higher rate of patients with excellent cosmetic outcome (59% vs. 30% and 45%).
Two other studies examined the efficacy of Metvix® PDT in organ transplant patients with AK lesions. Non-melanoma skin cancers are 50-100 times more frequent and also more aggressive in organ transplant patients due to immuno-suppression. These lesions cause large morbidity and high mortality in transplant patients. There is therefore a great need for new treatments with less scarring and disfiguration. In addition, there is a great medical need to develop treatments for these high-risk patients that can eliminate sub-clinical disease and prevent the development of more serious skin cancer lesions.
The studies revealed that Metvix® PDT showed the same high response rate on AK lesions as previously reported with Metvix® PDT in patients with normal immune function. One of the studies also examined the possibility to use Metvix® PDT to prevent occurrence of new skin lesions. Compared to placebo, the skin areas treated with Metvix® PDT showed significantly less development of new skin lesions. This indicates that Metvix® PDT can be used in this type of patients to eliminate lesions before they can be identified clinically. In this way, Metvix® PDT can prevent development of more serious cancer lesions.