New data provide evidence that Hexvix® can improve the overall survival in bladder cancer patients

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.

Oslo, Norway, 29 January 2015:  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/Cysview guided 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)

 

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 20 3440 5653, Email: photocure@humebrophy.com