PhotoCure ASA presents positive results from a European multicentre study of Metvix® PDT in skin cancer (BCC)

PhotoCure recently completed its clinical program on actinic keratosis (AK), a pre-cancerous skin disorder, for a European Market Authorisation Application of Metvix®. In this announcement we report the first clinical multicentre study (phase II) in skin cancer (basal cell carcinoma). In a European study involving 141 patients at 8 research centres in Sweden, Finland, France, Netherlands, Switzerland, and Norway, Metvix® photodynamic therapy (PDT) cured more than 90% of the skin cancer lesions when examined 3 months after treatment. In the majority of the cases the cosmetic outcome after Metvix® PDT was evaluated both by the investigator and the patients themselves as excellent. The patients will be followed for 3 years after treatment.

”We are happy that these results confirm the good experience with Metvix® PDT previously observed at the Norwegian Radium Hospital, and we hope that the ongoing phase III studies, will confirm that Metvix®.PDT is a preferred treatment alternative for patients with this type of skin cancer” says CEO and professor Vidar Hansson.

PhotoCure had recently a meeting (end-of phase II meeting) with the United States Regulatory Authority (Food and Drug Administration). In this meeting PhotoCure presented its clinical results on Metvix® PDT for treatment of BCC and the design of ongoing phase III studies with Metvix® PDT. The meeting concluded that the ongoing clinical program for Metvix® PDT in skin cancer would also be relevant for obtaining registration for Metvix® in the United States.

“Based on the positive meeting with FDA, and the fact that we follow the plans and time lines for development of Metvix® PDT in skin cancer, we believe it is possible to apply for marketing approval for this type of skin cancer simultaneously in Europe and USA” says Vidar Hansson.

PhotoCure ASA is a Norwegian company founded in 1993. PhotoCure ASA mission is to develop and sell pharmaceuticals and medical devices for photodynamic therapy (PDT) and diagnosis of cancer and pre-malignant diseases. All of the company’s products are based on proprietary technology from the Norwegian Radium Hospital, the largest comprehensive cancer centre in Northern Europe. PhotoCure has completed final registration studies (phase III) with its first products, Metvix® and Curelight in Europe for Actinic Keratosis (pre-cancerous skin lesion), and plans to file its first application for marketing approval during May year 2000. PhotoCure will apply for a listing of the company’s shares on the Oslo Stock Exchange during 2. quarter this year.

Oslo, Norway 22st of March 2000