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New Analysis Shows Hexvix®/Cysview® Significantly Prolongs Time To Progression Of Bladder Cancer

April 29, 2016
Photocure ASA (OSE: PHO), is pleased to announce publication of a new analysis demonstrating that Blue Light Cystoscopy (BLC) with Hexvix/Cysview significantly prolonged time to disease progression and showed a trend in the reduction of the rate of progression in patients with non-muscle invasive bladder cancer (NMIBC). The data was published online in the April issue of the peer reviewed journal, Bladder Cancer.

The new analysis of a long term follow-up study classified patients according to the new International Bladder Cancer Group (IBCG) definition of disease progression, which was created to more accurately identify patients with high risk of developing invasive disease at an earlier stage, in order to optimize treatment decisions1.

Using the new IBCG definition, overall time to disease progression was significantly longer in the BLC with Hexvix/Cysview group (p=0.05). Additionally, there was a clear trend towards a reduction in the rate of progression, with 31 (12.2%) BLC with Hexvix/Cysview and 46 (17.6%) white light only patients progressing after 4.5 years (p=0.085). This trend was particularly pronounced in patients from having smaller, papillary lesions (stage Ta) to high risk flat lesions (CIS): 4 (1.6%) in the Hexvix/Cysview group compared to 11 (4.2%) in the white light group.

Dr. Ashish M. Kamat MD, MBBS, FACS Professor Department of Urology, Division of Surgery, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas and lead author on the publication commented “The updated findings support the importance of improved tumor detection and resection of bladder tumors at an early stage and its impact on the long term prognosis for patients. These results confirm and extend the prior reported benefits of using BLC with Hexvix/Cysview over white light alone in the management of NMIBC, particularly at the first resection.”

Dr. Kjetil Hestdal, President & CEO of Photocure ASA added: “We are delighted to see the ever growing body of clinical evidence that supports the beneficial impact of BLC with Hexvix/Cysview for bladder cancer patients. Better detection and reduction in recurrence for patients undergoing BLC with Hexvix/Cysview has been extensively documented. This long term follow-up study analyzed with the new definition of progression further demonstrates that BLC with Hexvix/Cysview plays an important role in the management of bladder cancer and provides patients with sustained and long term benefits.”

In the original analysis, published in the Journal of Urology in 2012, the definition of progression was from non-muscle invasive to muscle invasive bladder cancer. That analysis demonstrated a prolonged time to recurrence with a trend towards less progression; after 4.5 years (median), 8 (3.1%) Hexvix/Cysview and 16 (6.1%) white light patients had progressed.

The new IBCG definition includes the following as indicators of disease progression: an increase in stage from Ta to CIS or T1, CIS to T1 (indicating invasion of the bladder lining or lamina propria), development of T2 or greater, lymph node disease (N+), distant metastasis (M1) or an increase in grade from low to high.

Hexvix/Cysview is a photosensitizing agent taken up selectively by the tumor cells in the bladder that when exposed to blue light during a cystoscopic procedure results in a bright pink fluorescence of the suspicious tissue. Using Hexvix as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence and prolongation in time to disease progression.

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Notes for Editors
The Impact of Blue Light Cystoscopy with Hexaminolevulinate (HAL) on Progression of Bladder Cancer – A New Analysis,” by Kamat, Ashish M., Cookson, Michael, Witjes, J. Alfred, Stenzl, Arnulf, Grossman, H. Barton. It is published in Bladder Cancer, Volume 2, Number 2, 2016 by IOS Press. The article is freely available online: http://content.iospress.com/articles/bladder-cancer/blc160048

For further information, please contact:

Kjetil Hestdal
President and CEO
Photocure ASA
Tel. +47 913 19 535
KH@photocure.no

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique propriety Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions in disease areas with high unmet medical needs such as bladder cancer, HPV and precancerous cervical lesions and skin conditions. Our aim is to provide solutions that can improve health outcomes for patients worldwide.  Photocure is listed on the stock exchange (OSE: PHO).  Information about Photocure is available at www.photocure.com.

About Hexvix®/Cysview® is the trademark in the USA and Canada

Hexvix®/Cysview® (hexaminolevulinate hydrochloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. Hexvix®/Cysview® is approved in Europe, USA and Canada.

About bladder cancer

Bladder cancer is the fifth most common cancer in men with more than 380 000 new cases annually and more than 150 0002 die of the disease. It 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. It is a costly, potentially progressive disease for which patients have to undergo multiple surveillance cystoscopies because of the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

1. Lamm et al: Defining Progression in NMIBC. It is time for a new standard definition of Journal of Urology Vol 191, 20-27 January 2014
2. www.globocan.iarc.fr (05-11-2013)

The information is subject of the disclosure requirements acc. To 5-12 vphl (Norwegian Securities Trading Act)