Oslo, Norway, December 5, 2016 Photocure ASA (PHO-NO) announced today new data from a prospective multicenter real world study that included 338 patients, 415 BLC procedures and 1060 lesions from nine study sites in the United States. BLCC as an adjunct to white light cystoscopy (WLC) resulted in the detection of an additional 151 lesions and 45 patients uniquely with the addition of blue light. This resulted in upgrading or upstaging of 52 (15%) of the patients. Correct staging and grading impacts the management of bladder cancer patients and may have an impact on patient outcomes. Please see attached abstract for more information.
The registry data were presented at the SUO 17th Annual Meeting, November 30th to December 2nd, 2016, San Antonio, Texas, USA.
"The BLCC registry continues to provide additional data from real world clinical practice. BLC with Cysview® has identified additional high grade cancers and thus change the management of bladder cancer patients from a diverse group of urologic oncologists from around the country. With additional follow-up these data may undoubtedly affect cancer specific outcomes. In my clinical practice, the inclusion of BLCC in the AUA/SUO guidelines and the data coming out from this registry study provide additional strong evidence that BLCC should be considered as standard of care by most urologists", says study participant Trinity J. Bivalacqua, M.D., Johns Hopkins, R. Christian B. Evensen Professor of Urology and Oncology and Director of Urologic Oncology at the James Buchanan Brady Urologic Institute.
In addition, a second poster was presented at the SUO meeting on the safety of repeat use of BLC with Cysview®. This retrospective review from two institutions in the United States compared the incidence and grade of Adverse Events (AE's) after initial and subsequent BLCC procedures. 35% of the patients underwent BLCC more than once; 2 patients five times. No statistically significant difference in AE's between those patients undergoing first versus two or more repeat procedures were found. Please see attached abstract for more information.
"Many studies have shown that BLCC has clear benefits over WLC alone in improving the detection and management of patients with non-muscle invasive bladder cancer (NMIBC). The registry study is demonstrating how BLCC is changing patient management and clinical outcomes in different patient types in daily clinical practice. Additionally, the safety data on the repeat use of BLC and Cysview® in the US are supportive of the current clinical practice in Europe, and demonstrate that using BLC with Cysview® repeatedly in the same patient has no safety concerns," says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.
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 wall.6 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 treat.7
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 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 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 www.photocure.com.
For more information, please contact:
Photocure 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
[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.
