PhotoCure starts clinical trials in USA
Start up of clinical trials in the USA are according to plans and an important step towards the North American market. The discussions with FDA concerning start of clinical trials in the US has proceeded very rapidly and without problems, and we are pleased to receive the approval of our IND by FDA since American Health Authorities is considered as one of the most demanding and strict in the world, says PhotoCures CEO, Professor Vidar Hansson.
The first clinical trials to be performed concerns non-melanoma skin cancer and other skin disorders in patients that previously has undergone an organ transplantation. Patients that have undergone a transplantation must receive life-long immuno-suppressive treatment, and will for that reason have a very high frequency of such skin cancer. Clinical studies on other types of patients will follow shortly.
Metvix has until now been investigated in more than 2000 patients in controlled clinical trials and the results so far show that it is an effective and safe treatment. The advantage of Metvix compared to traditional treatment is that Metvix PDT gives an outstanding cosmetic result and is more comfortable for the patient.
PhotoCure ASA is a Norwegian company founded in 1993. PhotoCure ASA mission is to develop and sell pharmaceuticals and medical device for photodynamic therapy and diagnostic of cancer and pre-malignant disease. All of the companys products are based on proprietary technology from research units at the Norwegian Radium Hospital, the largest comprehensive cancer centre in Northern Europe. The first products, Metvix® and Curelight are being tested in final registration studies (phase III) for non melanoma skin cancer (Basal Cell Carcinoma) and Actinic Keratosis (pre-cancerous skin lesion) and the company plans to file its first Market Authorisation Application during year 2000.
Oslo, Norway 23.12. 1999