Late-Breaking Plenary Presentation at the AUA 2017 Annual Meeting on Blue Light Flexible Cystoscopy (BLFC™) with Hexaminolevinulate (HAL) Phase 3 Study

Data on US Registry Study for BLC™ with Cysview/Hexvix will also be Presented at AUA.

Oslo, Norway, April 26, 2017: Photocure ASA (Photocure, PHO:OSE), today announced that results from the BLFC with Cysview®/Hexvix®  Phase 3 study will be presented during a late-breaking plenary session at the American Urological Association (AUA) Annual Meeting in Boston, Mass., May 12-16, 2017. 

The late-breaking presentation will report results from a prospective multi-center study, carried out at 17 centers in the United States (US), on detection and impact on patient management of Cysview in patients with non-muscle invasive bladder cancer undergoing surveillance with a flexible cystoscopy to detect the recurrence of bladder cancer.

New data will also be presented at AUA on a prospective multicenter registry that has been established to study the use of BLCTM (Blue Light Cystoscopy) with Cysview in the operating room setting. This registry, which is the largest non-muscle invasive bladder cancer registry in the US, continues to add to the growing body of evidence of how BLC with Cysview can improve the detection and management of bladder cancer in various patient populations.

Key activities during the AUA 2017 meeting include:

  • Friday May 12:
    • 1 to 3PM ET- BCEC room 252 Poster session MP15-02: Blue Light Cystoscopy for the diagnosis of Urothelial Bladder Cancer: results from a prospective multicenter registry.
  • Sunday May 14:
    • 2 PM ET- BCEC Ballroom: Surgical Techniques: Endoscopic Diagnosis and Transurethral Resection of Superficial Bladder Cancer
    • 3 PM ET- BCEC Ballroom: PPTLBA-02: Late-Breaking Abstract - Blue Light Flexible Cystoscopy (BLFC™) with Hexaminolevulinate (HAL) and White Light Flexible Cystoscopy: A Prospective, Comparative, Within-Patient Controlled Multi-Center Phase 3 Study in the Detection of Bladder Cancer during Surveillance.  http://www.jurology.com/article/S0022-5347(17)39292-3/abstract
    • 1 PM to 5 PM ET - Westin Waterfront, Douglass Room - Urological Society of American Veterans (USAV) meeting and program. During the meeting, there will be a panel discussion that will include BLC with Cysview® cases from the Veterans Administration Medical Centers.
  • Photocure will be exhibiting BLC™ with Cysview in Booth 1109 during the AUA 2017 meeting.    

 

About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US1, 2, 3.  In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer. Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, chronic bladder irritation and infections, and prior diagnosis of bladder cancer.  Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year4,5.

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 wall6.  NMIBC is still in the inner layer of cells. 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 treat7.

About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an optical imaging agent used 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® is the tradename in Europe, Cysview® in US and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.  Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About Photocure ASA
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). Information about Photocure is available at www.photocure.com.

About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call (800) 421-0837 or visit the company’s website at www.karlstorz.com.

For more information, please contact:
Kjetil Hestdal
President and CEO, Photocure ASA
Tel: + 47 91319535
Email: mailto:kh@photocure.no

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

Media Relations:
Emily Dell
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: emilyd@mcspr.com

 

1 SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2016.

2 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

3 Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178 (6):2314-2330.

4 Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology. 2006; 68:549-553.

5 Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003; 21:315-1330.

6 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

7 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.