Oslo, 28 March 2003
PhotoCure ASA has previously in a multicenter European phase III study reported that Hexvix® fluorescence cystoscopy identifies approximately 30% more patients with aggressive bladder cancer (carcinoma in situ) compared to standard cystoscopy. PhotoCure has now completed the second multi-centre phase III study with Hexvix® fluorescence cystoscopy. This study investigated whether improved detection of bladder cancer lesions with Hexvix® compared to standard white light cystoscopy would lead to a more adequate treatment of the patients. The study took place at 10 university clinics in Germany and the Netherlands and included 146 patients with known or suspected bladder cancer.
The results obtained by an independent blinded reviewer (a urologist) showed that Hexvix® fluorescence cystoscopy would lead to a better treatment for every fifth patient compared to standard cystoscopy. Importantly, the investigators found Hexvix® useful for diagnosing bladder tumours as an add on to white light cystoscopy in 78% of the patients and beneficial in deciding further patient treatment in 42% of the patients.
Principal investigator in the study, professor Dieter Jocham from Lübeck, Germany, was very pleased with the results. "The fact that that practical patient treatment was changed to such large extent shows that this diagnostic tool will play a major role in the future diagnosis and follow up of patients with bladder cancer."
President and CEO of PhotoCure ASA, professor Vidar Hansson says: "We are delighted that these new results confirm the results from the our first Phase III study. More important, these results show the important implications of the Hexvix® diagnosis for treatment of bladder cancer patients."
Bladder cancer is the sixth most common malignant disease worldwide. Every year more than 4 million cystoscopies 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.