New study shows PDD Hexvix and immediate post-TURB chemoprophylaxis reduces the risk of recurrence and number of follow-up procedures in NMIBC

Oslo, Norway, 12 March 2015: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, is pleased to announce that a study published in Scandinavian Journal of Urology concludes that fluorescence cystoscopy with Hexvix® and immediate post-transurethral resection of the bladder (TURB) chemoprophylaxis effectively reduced the recurrence risk and the number of follow-up TURB procedures under clinical routine conditions.

The aim of the study was to evaluate the effect of using fluorescence cystoscopy with Hexvix and immediate post-TURB chemoprophylaxis on the risk of recurrence under routine clinical conditions.

In total, 190 consecutive patients were enrolled over a two year period (2008-2010) and followed as the intervention group; additionally, 216 patients treated over a two year period (2006-2008) prior to the introduction of fluorescence cystoscopy with Hexvix® and immediate post-TURB chemoprophylaxis, served as a control group. The Intention to Treat analysis showed a 41% reduction in the risk of recurrence (hazard ratio 0.59, 95% confidence interval 0.45-0.78), and median recurrence free survival was extended from 13.6 months to 36.8 months. Every third follow-up TURB procedure was avoided. The study showed that patients with primary and recurrent disease, as well as those with low-risk tumors benefited from the treatment. The study also concluded that the procedure was cost-effective, with savings realized through the reduced number of TURB procedures

The project was performed at Randers Regional Hospital, Denmark, and the lead investigator, Dr. Karsten Zieger, stated: “These retrospective data collected under a routine clinical setting using photodynamic diagnosis with Hexvix and immediate post-TURB chemoprophylaxis show the potential of this treatment to reduce the risk of recurrence and the need for follow-up procedures. This will benefit the patients with longer recurrence free survival and less burden with fewer TURB procedures and at the same time reduce the burden on the health care resources”.

Kjetil Hestdal, President and CEO of Photocure, said: “These real life data demonstrating the benefit of Hexvix/Cysview both for the bladder cancer patients and the health care society highlight the significant value of Hexvix/Cysview and support the strong data we have delivered in our randomized clinical trials. We are very pleased that practicing clinicians are taking these important initiatives to develop evidence of the value of photodynamic diagnosis for their patients and clinics in a real world setting”.

Bladder cancer, which affects over 1,000,000 people in the U.S. Europe annually, has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers.

The full article in Scandinavian Journal of Urology can be found here:  http://informahealthcare.com/doi/pdf/10.3109/21681805.2015.1019562

For further information, please contact:

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

CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no

 About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue-light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white-light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence. Hexvix®/Cysview® is approved in Europe and the USA.