PhotoCure ASA announced the completion of a European Phase III multicentre study, where more than 100 patients with nodular basal cell carcinoma (BCC), a non-melanoma skin cancer, were treated either with photodynamic therapy (PDT) or surgery. Both treatments gave high initial cure rates three months after treatment, with Metvix(R) PDT showing significant improvement in cosmetic outcome over surgery.
Nodular BCCs are often thicker and more difficult to treat than superficial BCCs, and they occur more often in the face. Metvix(R) PDT is a novel treatment which involves application of a cream, Metvix(R), that is absorbed only by cancer cells, and is subsequently activated by a proprietary red light source (Curelight), so that the cancer cells are selectively destroyed, leaving the normal skin to heal without scars. Metvix(R) is pending approval in Sweden and Australia for pre-cancerous actinic keratosis and "high risk" BCC.
After surgical excision, 98% of lesions disappeared completely, compared to 90% of the lesions treated with Metvix(R) PDT. However, there was no statistically significant difference between the treatment groups. In the cosmetically important facial lesions, the cure rates were 97% for surgery and 95% for Metvix(R) PDT. The cosmetic outcome was much better after Metvix(R) PDT than after surgery. The dermatologists graded the cosmetic outcome as "good" or "excellent" in 83% of the patients treated with Metvix(R) PDT, versus only 15% in the surgery group.
The side effects in both groups were mainly mild and transient, and none lead to treatment discontinuation or other medical interventions.
Dr Lesley Rhodes of Manchester University, who was the lead investigator for this study, said: "The Metvix(R) PDT trial is a breakthrough, as it is the first randomised multicentre study comparing topical PDT with the standard surgical treatment. The new study demonstrates that a double treatment with Metvix(R) PDT, following careful lesional surface preparation, is close to surgery in achieving cure of skin cancers. Treatment with Metvix(R) PDT however produces considerably improved cosmetic results compared with surgery, and can therefore be a suitable alternative particularly beneficial for cosmetically sensitive skin areas."
PhotoCure President & CEO Vidar Hansson was also very pleased with the results and commented: "The fact that this randomised study has shown the clear benefits of Metvix(R) PDT in the overall treatment of nodular BCC lesions, should increase significantly the commercial potential of this therapy."
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. Metvix(R) and Curelight is developed for the treatment of basal cell carcinoma (skin cancer) and actinic keratosis (pre-cancerous skin lesions). PhotoCure's second pharmaceutical product, Hexvix(R), is currently undergoing clinical trials for bladder cancer detection. PCI Biotech AS is established as a subsidiary of PhotoCure ASA to develop and commercialise new transfection technologies for the research market as well as products in oncology and gene therapy.