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PhotoCure Release: New Publication on Hexvix(R) Demonstrating that Hexvix(R) Guided Fluorescence Cystoscopy Reduces Recurrence in Patients with Non-muscle Invasive Bladder Cancer


10/5/2010 12:31:39 PM

Oslo, Norway, October 5th 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.

For further information, please contact Photocure 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

Media Enquiries Capital MS&L Mary Clark, Justine Lamond and Hollie Vile Ph: +44 (0)20 7307 5337 Email: Photocure@capitalmsl.com

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



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