PhotoCure is pleased to announce positive long- term recurrence data from its Metvix® photodynamic therapy (PDT) trial on patients with Basal Cell Carcinoma (BCC) lesions that were deemed unsuitable for standard therapy such as cryosurgery, surgery, reconstructive plastic surgery or irradiation. The data released today covering the 12 months follow-up period confirms the positive trends both in treatment response and clinical outcome announced earlier in the year. The 12 month follow up data showed a low overall recurrence rate of 9%, and for lesions located in cosmetically sensitive areas as the face, head and scalp and extremities (75 % of lesions), no recurrences were observed at 12 months.
The initial results from this trial, which were reported in March 2000, showed that a clinically evaluated complete response was achieved in 89% of the BCC lesions three months after treatment with Metvix® PDT. Nine clinical dermatological centres across Europe participated in this study.
Professor Peter Wolf from Austria, an international leader in the field and primary investigator of this multi-centre study says: “I consider it very encouraging to see that these patients now can get a treatment alternative which only consist of cream and red light illumination, and obtain excellent cosmetic results without any need for reconstructive plastic surgery. I believe that the results from this study clearly demonstrate the usefulness of PDT in this group of patients.”
“The crucial follow up results that we have announced today confirms the value of Metvix® PDT particularly as they have been achieved in patients with BCC who were deemed unsuitable for traditional treatment regimes. These results mean that we now have the long term data needed to submit our second marketing approval application (MAA) for Metvix® PDT” said Photocure’s CEO Vidar Hansson. Our first MAA for Metvix® PDT for the treatment of actinic keratosis (AK) is progressing according to the plan, and is currently under evaluation by the Swedish regulatory agency. We plan to submit our new MAA covering the treatment of BCC with Metvix® PDT within the next three months in Sweden as the first step to gaining European approval. In the first quarter of next year we also plan to submit an MAA in Australia for AK and BCC unsuitable for traditional therapy”
Basal cell carcinoma, or BCC, accounts for approximately 80% of non-melanoma skin cancers. There are over 1.7 million cases of BCC each year in Europe, the U.S. and Australia, and the incidence of the disease has grown at 5% per annum during the past decades. BCC is a locally invasive, slowly spreading tumour arising from the basal cell layer of epidermis. The overall metastasis rate is very low, but if the tumour is not initially adequately treated, it may become more difficult to cure. Furthermore, the location of BCC has significant influence on its behaviour. The lesions that occur in the centre of the face tend to be more invasive and destructive, with greater risk of recurrence, and are more difficult to treat effectively. BCC on the nose is considered to be the location with highest risk and the most common location of recurrence. Patients with a primary BCC have a 47% chance of developing a second primary lesion within 3.5 years indicating the need for frequent skin scrutiny in these patients.
PhotoCure ASA is a Norwegian listed company founded in 1993. PhotoCure ASA 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. PhotoCure has completed final registration studies (phase III) with its first products, Metvix® and Curelight for actinic keratosis (pre-cancerous skin lesion), and has filed its first application for European marketing approval in May year 2000. Pivotal clinical trials for skin cancer (basal cell carcinoma or BCC) are ongoing and an application for marketing approval for BCC unsuitable for standard therapy will be filed 1st quarter 2001.
Oslo 11th of December 2000.