PhotoCure ASA has finished the first multi-centre phase III study with Hexvix® for detection of bladder cancer. This clinical phase III trial, recruiting 211 patients with high risk for bladder cancer, took place at 19 leading university clinics throughout Europe. The main objective with this phase III study was to examine whether Hexvix® fluorescence cystoscopy (visual bladder inspection)  detected more flat cancer lesions (carcinoma in situ, CIS) than standard white light cystoscopy alone.

In a majority of the patients with such cancer lesions, more patients with bladder cancer were found with Hexvix® than with standard white light cystoscopy. Employing Hexvix® fluorescence cystoscopy, 97% of the CIS lesions were detected compared to 59% with standard method. Regardless of lesion type, Hexvix® identified 97% of all tumours, compared to 78% for white light. The investigators reported that in more than 60% of the patients, the Hexvix® cystoscopy gave valuable information for the diagnosis and treatment of the patients. The safety profile of Hexvix® was excellent with no major side effects reported.

Principal investigator of the study, Professor Michael Marberger from Vienna, was pleased with the results. “Even in this high risk patient population, Hexvix® photodiagnosis was a very useful supplement to standard white light cystoscopy and may give critical new information about the presence of CIS lesions. This is very important for the treatment and prognosis of the patient. I believe Hexvix® fluorescence cystoscopy will play an important role in the future management of bladder cancer.”

President and CEO of PhotoCure ASA, professor Vidar Hansson, says: “Positive results from our first phase III clinical study is a very important milestone for PhotoCure, and we are on track in our development program  to be able to submit a market authorisation application during first half of 2003. With Hexvix® PhotoCure is now about to strengthen its commercial platform considerably.”

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 66 500 in Europe. The incidence of bladder cancer is increasing and is strongly influenced by age and long-term smoking. 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.