Photocure (OSE: PHO), a Norwegian pharmaceutical company specialising in cancer and dermatology, announces the results from a 5.5 year follow up of recurrence in patients with Non Muscle Invasive Bladder Cancer( NMIBC) showing a long term benefit of the use of Hexvix compared to patients who received white light cystoscopy alone. After a follow-up up period up to 5.5 years, the number of patients who have experienced recurrence of their bladder cancer is lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy.

This clinical study includes retrospective follow up from 526 patients included in a prospective randomized Phase III trial in 28 centers in EU and North America. The results from this Phase III study were published in Journal of Urology November 2010 by Stenzl et al. In this 5.5 year follow- up study data were collected related to additional bladder cancer recurrences after they had completed the prospective Phase III trial.

The results (Intention to Treat) showed that fewer patients who received Hexvix experienced recurrence of their bladder cancer compared to patients who did not receive Hexvix, e.g. 38% in the Hexvix group versus 31.8% in the group that did not receive Hexix had no recurrence during the 5.5 year observation period. A statistically significant difference was observed between the recurrence free survival curves, p=0.04.

Dr. H. Barton Grossman, Clinical Professor of Urology at MD Anderson Cancer Center, Houston, USA says," The results of this long-term follow up study are very impressive and demonstrate that Hexvix is an important tool to improve the detection and treatment of bladder cancer".

Bladder cancer has the highest rate of recurrence of all cancer types. This results in a very high prevalence of disease which requires patients to return for regular follow-ups and treatment. Per patient, bladder cancer is the most expensive cancer to treat, in part because of the diagnostic testing and treatment of recurrent disease.

Kjetil Hestdal, President & CEO of Photocure comments, "We are very pleased to see the results of this study which demonstrates the long-term benefit of using Hexvix-guided fluorescence cystoscopy for patients with bladder cancer. We have earlier demonstrated in two clinical studies that there is a reduction of bladder cancer recurrence after using Hexvix- guided fluorescence cystoscopy at 9 and 12 months. This is the first study to demonstrate that this effect is durable lasting for over 5 years".

Source:
Photocure, Inc.
GE Healthcare