Oslo, Norway, December 8, 2017: Photocure ASA (Photocure, PHO: OSE), today announced that the official Journal of the American Urologic Association (AUA), the Journal of Urology, published the BLFCC Efficacy results from a Phase 3 trial investigating the efficacy of Blue Light Cystoscopy (BLC(TM)) with Cysview® for surveillance with a flexible cystoscope. In 20.6 percent of patient's recurrence was seen only with BLC with Cysview and missed with WLC (p<0.0001).
Out of the 304 patients in the study, 103 were referred to the Operating Room for suspicion of recurrent bladder cancer. Of these, 63 patients were confirmed as having malignant tumors. Forty one percent of the patients with malignant tumors were confirmed as having CIS (Carcinoma in Situ), the most aggressive and difficult to detect and treat type of non-muscle invasive bladder cancer (NMIBC). Importantly, 34% of these patients were detected only with BLC with Cysview (p<0.0001) but were missed with WLC.
"This study, which despite being carried out in centers with bladder cancer and BLC expertise, showed that blue light flexible cystoscopy significantly (p<0.0001) improves detection of patients with recurrent bladder cancer. BLC detects lesions, including CIS that were missed with WLC alone. The detection of additional tumors in the surveillance setting may have profound effects on progression rates through earlier diagnosis of high risk lesions which would have been otherwise missed with WLC. The results of this study confirm the role for BLC in the management of intermediate and high risk bladder cancer patients," saysJ. Stephen Jones, MD, president of Cleveland Clinic Regional Hospitals and Family Health Centers.
"This publication reports the data included in the supplemental NDA submitted to the FDA to get approval for the use of BLC with Cysview in the surveillance setting with flexible cystoscopy. We look forward to bringing this technology to bladder cancer patients and their health care providers for the follow-up of NMIBC in the office setting," said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA."
The study is a prospective, open, comparative within-patient controlled study of 304 patients with high risk of recurrence enrolled at 17 academic centers in the US.
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.
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Source: Photocure ASA via Globenewswire