New publication on Hexvix demonstrating that Hexvix guided fluorescence cystoscopy reduces recurrence in patients with non-muscle invasive bladder cancer

Oslo, Norway, October 5, 2010. 

Photocure today announces a newly published publication in Journal of Urology on Hexvix. This publication shows that Hexvix guided fluorescence cystoscopy (Hexvix^®), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.

The publication is based on Photocure's prospective, randomised study conducted in 28 centres in Europe and North America. The study demonstrated that by using Hexvix^®-guided fluorescence cystoscopy Ta/T1 tumours that had not been seen under conventional cystoscopy were detected in 47 (16%) of the patients with Ta or T1 tumours (p=0.001). Of these tumours that were only seen using Hexvix cystoscopy, 28 (59%) were medium-grade tumours (G2), and 19 were tumours of high risk of recurrence and progressions (high grade or T1). Furthermore, 32% of the patients with carcinoma in situ (CIS, a, high-grade aggressive cancer) were identified only by Hexvix^®-guided fluorescence cystoscopy.

The study group, led by H. Barton Grossman, Professor of Urology at MD Anderson Cancer Center, Houston, USA, also reports a 16% relative reduction of bladder tumours recurrence in patients with Ta /T1 tumours  assessed with Hexvix^®-guided fluorescence cystoscopy, compared with white-light cystoscopy alone (p=0.026). At 9 months' follow up, there was a 9% absolute decrease in recurrence in the Hexvix^® group, compared with white-light cystoscopy alone, which means that only 11 patients needed to undergo the procedure to avoid one recurrence.

The group also report reduced recurrence of aggressive/clinically significant lesions. They found more CIS, T1 and muscle-invasive disease recurrence in the patients who had undergone white-light cystoscopy compared to Hexvix guided cystoscopy (24% vs 16%, respectively, p=0.17).

As the paper points out, improved tumour detection is likely to result in more accurate tumour mapping and disease staging, and hence more complete cancer resection. A reduced recurrence rate is an objective marker for these benefits.

Per patient, bladder cancer is the most expensive cancer to treat, in part because of the diagnostic testing and treatment of recurrent disease. Professor Stenzl and his co-authors explain that although the introduction of Hexvix^®-guided fluorescence cystoscopy involves a financial outlay, the technique is easy to learn, and there is evidence from across Europe that the initial cost will be offset by prolonged disease-free survival.

President & CEO
Kjetil Hestdal
Phone: + 47 913 19 535
Email: kh@photocure.no

CFO Christian Fekete
Phone: + 47 916 42 938
Emaill: cf@photocure.no

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 dermatology indications.

Photocures commercial activities includes own marketing and sales in selected markets as well as out-licensing to leading pharmaceutical companies 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 and in the US. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac(TM)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(TM)platform.

Photocure® and Hexvix® are registered trademarks of Photocure ASA.

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

Notes to editors

· The trial is reported in: Stenzl A, Burger M, Fradet Y et al. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol 2010; 184: 1907-1914

· Classification of bladder cancer includes assessment of tumour spread (T) and grade/aggressiveness (G). Ta and T1 cancers are localised (non-muscle-invasive [NMIBC]), but may be high grade. For example, a TaG3 tumour is within the inner lining of the bladder, but is likely to undergo rapid spread. CIS is a very early, high-grade bladder cancer than can occur in more than one location on the bladder lining (http://www.cancerhelp.org.uk/type/bladder-cancer/treatment/bladder-cancer-stage-and-grade#grade)

· NMIBC is associated with a 25-70% risk of recurrence and a 15-20% risk of progression (Bunce C, Ayres BE, Griffiths TRL et al. The role of hexaminolevulinate in the diagnosis and follow up of nonmuscle-invasive bladder cancer. Br J Urol Int 2010; 105(Suppl): 2-7.)

· When treated effectively, NMIBC has an excellent prognosis, but progression to muscle-invasive disease is associated with poor survival rates, i.e. less that 50% at 5 years (http://info.cancerresearchuk.org/cancerstats/types/bladder/#survival)

· Hexvix^® is manufactured by Photocure ASA, Hoffsveien 48, NO-0377 Oslo, Norway.

Tel: +47 2206 2210; Fax: +47 2206 2218; email: info@photocure.no