New Data Provide Evidence that Hexvix® Can Improve the Overall Survival in Bladder Cancer Patients

OSLO, Norway, January 29, 2015 /PRNewswire/ --

In a retrospective study Hexvix fluorescence-guided bladder resection significantly improved overall survival and recurrence free survival compared to resection performed with standard white light

Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, is pleased to note that a study on the impact of Hexvix® on survival in bladder cancer patients has been published in the World Journal of Urology.

The study investigated the impact on survival in bladder cancer patients of photodynamic diagnosis (PDD)-guided bladder tumor resection (TUR-BT), including that guided by Hexvix (hexaminolevulinate (HAL)).

The findings from this retrospective study of 224 patients demonstrate for the first time that Hexvix guided TUR-BT in bladder cancer patients, who later progressed to requiring radical cystectomy (RC), significantly increased the three year overall survival (p=0.037) and the median three year recurrence free survival (p=0.002) compared to patients in the comparator group.

Dr. Georgios Gakis of the Department of Urology, Eberhard-Karls University at Tuebingen, Germany and lead author, stated: "These data indicate for the first time that improved patient management with HAL-guided TUR-BT can make a difference in outcomes even for those bladder cancer patients who later progress to advanced disease and require radical cystectomy."

Kjetil Hestdal, President and CEO of Photocure, said: "These exciting data add to the growing clinical evidence that Hexvix/Cysview makes a positive impact on the diagnosis and management of bladder cancer in multiple patient types. We believe the continuously increasing adoption of Hexvix/Cysviewguided TUR-BT will bring significant clinical and health economic benefit to urologists, patients and payers fighting the disease."

The paper was a retrospective analysis of data from 224 consecutive bladder cancer patients undergoing RC. Of these patients, prior to RC, 66 (29.5%) underwent hexaminolevulinate (HAL)-guided bladder tumor resection (TUR-BT), 23 (10%) 5-aminolevulinate (ALA)-guided TUR-BT and 135 (60.2%) white light (WL)-guided TUR-BT.  

Three Year Overall Survival (OS): 74.0% in patients with HAL-TUR-BT compared to 60.9% with ALA-TUR-BT and 56.5% with White Light-guided TUR-BT. (p=0.037 for HAL vs. ALA/WL.)

Median Three Year Recurrence Free Survival (RFS): 77.8% for patients with HAL-based TUR-BT compared to 53.6% for ALA-TUR-BT and 52.5% for White Light-guided TUR-BT. (p=0.002 for HAL vs. ALA or WL.)

Bladder cancer, which affects 550,000 people in the U.S. and 500,000 in Europe has a high recurrence rate, up to 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest of all cancers.

The link to the article by G. Gakis, A. Stenzl et al can be found here: (http://link.springer.com/article/10.1007%2Fs00345-015-1485-8)

Notes to editors

About Photocure ASA

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

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 US.

Bladder cancer has a high incidence, and is the fourth most common type of cancer in males in the US. An estimated 75,000 new cases will be diagnosed with cancer of the bladder in 2014, with an estimated 15,600 people dying from the disease, according to the American Cancer Society. In Europe bladder cancer is the fifth most common cancer with an estimated 167 000 newly diagnosed cases and 59 000 deaths due to the disease in 2012 (Witjes JA et al., Eur Urol 2014). If bladder cancer is detected at an early stage, management and outcome for the patient is improved.

For further information, please contact:

Photocure
President & CEO Kjetil Hestdal
Tel: + 47-913-19-535, Email: kh@photocure.no
CFO Erik Dahl
Tel: +47-50-55-000, Email: ed@photocure.no

Hume Brophy
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44(0)20-3440-5653, Email: photocure@humebrophy.com