The plenary presentation titled "Efficacy and Safety of Flexible Blue Light Cystoscopy with Hexaminolevinulate (HAL) in the Surveillance of Bladder Cancer: A Phase 3, comparative, Multi-Center Study" was presented by 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. As previously announced, results from the study showed a highly statistically significant improvement (p <0.0001) in the detection of patients with recurrence of bladder cancer using BLC(TM)with Cysview®with a flexible cystoscope, compared to white light (WL) alone in patients with non-muscle invasive bladder cancer (NMIBC).
In addition, an abstract on Patient Reported Outcomes was presented from the same Phase 3 study which demonstrated a positive impact on anxiety. "Anxiety decreased following flexible BLC with Cysview, and the majority of patients (94%) undergoing this procedure found it worthwhile. Many Urologists underestimate the impact of intense surveillance cystoscopy on the quality of life and anxiety for patients with a bladder cancer diagnosis. These results suggest that patients appreciate the extra confidence that BLC with Cysview provides, which likely decreases their anxiety", says Dr. Angela B. Smith MD, MS, FACS, Assistant Professor, University of North Carolina, Chapel Hill, North Carolina.
"Photocure is delighted to see data supporting the use of Hexvix/Cysview with flexible cystoscopy. The patient reported outcomes data adds a new level of understanding of the patient experience of having bladder cancer and the positive impact of BLC with Hexvix/Cysview on patient anxiety and confidence," 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 US.1,2,3 In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer.
Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year.4,5
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. 2 NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (70%) 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. 2
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.
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
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
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.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.