Expert panel recommends the use of Hexvix®-cystoscopy

EAU, Barcelona, Spain - April 21, 2010: A European expert panel recommends the use of Hexvix®-cystoscopy in the diagnosis and follow up of non-muscle-invasive bladder cancer (NMIBC) (1)

Despite considerable positive evidence, the use of Hexvix has historically differed widely from country to country and between clinics. European recommendations from a consensus group have now been published, which may make the use of Hexvix-guided fluorescence cystoscopy more unison in Europe.

A group of European experts have reviewed and discussed the evidence for fluorescence cystoscopy using hexaminolevulinate Hexvix. When the group met in 2009, the members noted the accumulation of a strong evidence base for Hexvix-guided Transurethral Resection of Bladder (TURB) and that the technique was in use, as an adjunct to white-light cystoscopy in bladder cancer diagnosis, in many countries across Europe.

Various guidelines have been produced across the continent, acknowledging the role of fluorescence cystoscopy in the diagnosis and follow up of bladder cancer. However, there is no European consensus on its specific applications. In their analysis, the panel members argue that appropriate use of the technique brings benefits to patients, and to the healthcare economy, and they support the use of Hexvix-guided fluorescence cystoscopy in a range of indications. "We hope that our statement will lead to improved care and better outcomes for patients, through more complete resection of tumors and improved follow up" said Professor J A Witjes, chair of the panel.

The European expert panel's recommendations are available to support urologists in the clinical practice of fluorescence cystoscopy in the diagnosis and follow up of bladder cancer patients (Table 1).


Table 1. Recommendations from the European expert panel for the use of Hexvix-guided TURB in the diagnosis and follow up of bladder cancer

Indication

Role of Hexvix-guided TURB

Comments

Suspected bladder cancer *

· Tumour detection

· Tumour staging

· Guidance of resection

Fluorescence cystoscopy reduces the need for random biopsy and facilitates informed follow up

Tumour recurrence

· Tumour staging, if the patient was not previously staged using fluorescence cystoscopy

Fluorescence cystoscopy may detect previously missed tumours, particularly carcinoma in situ

Positive urine cytology in the presence of negative white-light cystoscopy

· Tumour detection

Fluorescence cystoscopy offers enhanced detection rates compared with white-light cystoscopy alone

Specialist training

· Clear visualisation of tumours and tumour margins

Assists clinicians in the development and improvement of their TURB technique


*If a patient with newly suspected bladder cancer is to undergo cystectomy, fluorescence cystoscopy is unlikely to provide additional information, and is not recommended by the expert panel.

"Each year there are approximately 120,000 new cases of urinary bladder cancer in Europe and it is the fourth most common malignancy in men and the eight most common malignancies in women", says expert panel member and Professor Per Uno Malmstrom, Department of Urology, University Hospital, Uppsala, Sweden. He adds, "Bladder cancer patients have access to effective therapies for the treatment of non-invasive tumours. However, up to 46% of bladder cancer will recur at first follow up. Fluorescence cystoscopy responds to the need for better diagnosis and treatment in order to reduce those recurrences".

Mr. Elgstrom, a bladder cancer survivor, says, "After the first operation the doctor told me the tumour was gone. Within the following year he discovered another tumour and I had to undergo surgery again. In my own experience, fluorescence cystoscopy can enable an earlier diagnosis, saving time, stress and suffering to the patient by increasing confidence in the treatment".

The European expert panel recommendations reflect the acceptance of the benefits which Hexvix provides to the bladder cancer patients and health-care providers. Hexvix, has through several studies shown significant improvement in detection of bladder cancer that relates to reduced recurrence of bladder cancer and improved patient management.2,3

References:
Witjes JA et al. Eur Urol 2010; 57: 607-614.
Stenzl AS et al. Hexvix® fluorescence cystoscopy improves detection and resection of papillary bladder cancer and reduces early recurrence: a multicentre, prospective, randomised study. Eur Urol 2009; 8 (4): Abstract #1010
The Danish recurrence study. Data on file, Photocure. Presented at the Nordic Urology Congress in Iceland, June 2009

About Photocure
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.

Photocure's commercial activities includes own marketing and sales in selected markets as well as out-licensing on a regional or global basis prior to phase III.

Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for the diagnosis of bladder cancer. Hexvix is approved in EU. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac™ cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products based on the Photocure Technology™ platform.

For more information about Photocure, visit our website at www.photocure.com.

Photocure®, the Photocure logo and Hexvix® are registered trademarks of Photocure ASA.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)