BLC™ with Cysview®/Hexvix® real World Data presented at the Société Internationale d’Urologie 2017 Annual meeting

Oslo, Norway, October 23, 2017 Photocure ASA announced that new data from the Blue Light Cystoscopy (BLC™) with Cysview®/Hexvix® registry study were presented at the 37th Société Internationale d’Urologie (SIU) Annual meeting, October 19-22, Lisbon, Portugal.

Data from the registry study, which is the largest US Bladder Cancer Registry Study, showed that BLC with Cysview resulted in an upstaging or upgrading of tumor with change in patient management in 13% of patients. The addition of BLC with Cysview to standard WLC increased the detection rate by 12% for any papillary and 44% for the more aggressive CIS (Carcinoma in Situ) bladder cancer lesions. The BLC with Cysview Bladder Cancer Registry Study is a prospective multicenter registry that included patients undergoing Transurethral Resection of Bladder Tumors (TURBT) from nine sites. The results presented included 533 patients who underwent 641 BLC with Cysview procedures, resulting in the identification of 1632 lesions.

“In this study, BLC with Cysview significantly increases detection rates of CIS and high-grade lesions compared to WLC alone. This in turn, resulted in a change in management for 13% of the patients, which can lead to an improvement in outcomes for these patients” says Dr. Siamak Daneshmand, Associate Professor of Urology (Clinical Scholar), Director of Urologic Oncology, at the University of Southern California Institute of Urology and study investigator.

Dr. Daneshmand also presented a Video Abstract which highlighted different scenarios producing false-positive data. The video referenced simple techniques to avoid false-positives (FP) and noted that reported FP rates of BLC decrease with experience and recognition of these scenarios. 

“This registry study demonstrates how BLC with Cysview/Hexvix is changing clinical outcomes, and provides more real world Data to further support its clinical use,” said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

Link to congress scientific program: http://bit.ly/2yIbv7N

About Bladder Cancer
Bladder cancer ranks as the ninth most common cancer worldwide with 430 000 new cases and more than 165 000 deaths annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3.

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to 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. 

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM).  BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US and the Nordic region, and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About Photocure
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). More information about Photocure is available at www.photocure.com, www.hexvix.com, www.cysview.com

Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no

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

References:
1. Globocan. Incidence/mortality by population.  Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx 
2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40. 3. Sievert KD et al. World J Urol 2009;27:295–300 4. Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016