Oslo, Norway, 5 October 2001.
PhotoCure ASA has now started patient enrolment in a European multicentre phase III study, designed to document the safety and efficacy of Hexvix® fluorescence cystoscopy for detection of bladder cancer. About 300 patients will be included at 20 centres. A similar trial will start in the US within a few months. Together the results of these two clinical trials will provide the clinical basis for international submissions for market authorisation.
Professor Steinar Karlsen, Head of Oslo Urological University Clinic, Aker Hospitall included the first patients in this study. Professor Karlsen says: "We already have some experience with Hexvix® fluorescence cystoscopy in detecting bladder cancer from the phase II studies earlier this year in collaboration with European colleagues. The method appears particularly useful for patients with flat lesions (carcinoma in situ, CIS), which are the most difficult ones to detect. We hope that this phase III study will confirm that Hexvix® cystoscopy adds useful information in the detection of bladder cancer."
Professor Vidar Hansson, PhotoCure's CEO and President, commented, "This is a very important milestone in the delvelopment of our second pharmaceutical product Hexvix®. The results from the early clinical development were positive and gives us reasons to believe that we will get similar good results in these crucial phase III studies. If these phase III studies remain on track, we expect to submit an marketing authorisation application (MAA) for Hexvix® during the first half of 2003."
Bladder cancer is the sixth most common malignant disease worldwide, and in 1990 more than 50 000 new cases were reported in the US and 66500 in Europe. Every year more than 2.5 million cystoscopies (bladder inspections) are performed in Europe and North America, in order to diagnose or rule out bladder cancer. The commercial potential for Hexvix® fluorescence cystoscopy is therefore very promising.