In clinical Phase II trials performed at university clinics in Switzerland, Germany, Sweden and Norway, Hexvix® fluorescence cystoscopy was shown to provide better diagnosis of bladder cancer compared to standard cystoscopy. The Hexvix® diagnostic procedure involves filling the patient's bladder with 50 ml of Hexvix® solution, for 60 minutes before the bladder is emptied and then later examined. Hexvix® accumulates in the cancerous cells and when illuminated with blue light, the cancer cells emit a red colour that makes the cancer cells clearly visible to the surgeon.
A total of 52 patients with known or suspected bladder cancer underwent both standard cystoscopy and Hexvix® fluorescence cystoscopy examination. Biopsies were taken from all visible tumours and suspicious areas to confirm the findings. Results showed that of 45 patients with bladder cancer, 29% had CIS (carcinoma in situ) tumours. Of these CIS tumour patients, 92% were diagnosed through Hexvix® fluorescence cystoscopy compared to 31% by standard cystoscopy. When assessing the results in terms of all bladder tumour types, 98% of patients with tumours were detected with Hexvix® compared to 80% by standard cystoscopy.
Dr Jichlinski, the primary investigator of the study from the University Clinic in Lausanne, Switzerland, said: "We were pleased to see that Hexvix® diagnostic greatly increased the detection of bladder cancer in this group of patients. Hexvix® fluorescence diagnostic for bladder cancer has been adopted for routine use in our clinic and provides an important tool for doctors treating this disease".
Professor Vidar Hansson, President and CEO of PhotoCure added: "With these results we are right on track with the development of Hexvix®. There are more than 2.5 million cystoscopy procedures carried out in Europe and North America every year and Hexvix® will provide valuable improvement on existing diagnosis of bladder cancer. With the encouraging results from this Phase II study we are now getting ready to start the Phase III studies in more than 30 centres in Europe and the US. The results from these trials will be used for submitting an NDA (New Drug Application) in the US and MAAs (Marketing Authorisation Applications) in Europe in 2003."
The results follow soon after the successful Swedish marketing approval of PhotoCure's first product, Metvix® PDT, a treatment for certain types of skin cancer which is now in the process of being recognised throughout Europe for further marketing approvals using the 90 day mutual recognition procedure.
Bladder cancer is currently diagnosed by cystoscopic examination, biopsies and detection of cancer cell in the urine. Diagnosing early stage tumours involves the insertion of a cystoscope into the patient's bladder for visual examination of the bladder walls. Early stage tumour tissue and carcinoma in situ (CIS) is particularly difficult to identify using this method.