Oslo, Norway, May 31, 2018: Photocure ASA (PHO:OSE) announced today that results from the Blue Light Cystoscopy (BLC™) with Cysview® Registry Study was published on-line, in the prestigious official journal of the Society of Urological Oncology. Data from the publication showed that BLC significantly increases detection rates of flat, aggressive Carcinoma in Situ lesions (CIS) and papillary lesions compared to WLC alone and can result in upstaging or upgrading in about 14% of patients and that repeat use is safe.
The publication is on results from a Prospective Multicenter Registry Study that is the largest Bladder Cancer Registry Study ever done in the US. This study is ongoing, and results were also presented at the annual AUA meeting held in San Francisco. Link to abstract: http://bit.ly/AUA2018BLCRegistry
"It has been very exciting to see the on-going increase in real world data as a result of this registry study. This publication based on data collected from 2014 to 2016, 9 referral sites, 1632 samples and 533 patients, show that the combination of White Light and Blue Light with Cysview increased the detection on papillary disease by 12%, CIS lesions by 43% and most importantly, resulted in change of management in 14% of patients. This means that patients are staged more accurately, which is very likely to impact their outcomes," 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. Link to the publication: http://bit.ly/BLC-Registry-Publication
The group has now expanded and has data from 1084 patients. "We look forward to continuing to learn from the results from this study and how the recent commercial launch of Cysview for use with flexible cystoscopes will further change the management of bladder cancer patients," says Kjetil Hestdal, MD, PhD, President and CEO, Photocure ASA., "I also want to thank the many investigators, their staff and patients for their participation in the study. The Registry Group has worked hard to bring this Real World Study forward and has brought a high level of scientific rigor which has resulted in many publications from this study."
About Bladder CancerBladder 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. It is estimated that in 2018 there will be 81,190 new cases of bladder cancer will occur along with 17,240 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
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 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.2
About Hexvix®/Cysview®Hexvix® is a drug that is taken-up selectively by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC™). BLC™ with Hexvix® 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 tohttp://bit.ly/PHO-Partnering for further information on our commercial partners.
About Photocure ASAPhotocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in Princeton, New Jersey. For more information, please visit us at www.photocure.com, www.hexvix.com or http://www.cysview.com
For more information, please contact:
Kjetil HestdalPresident and CEOTel: +47 913 19 535Email: mailto:firstname.lastname@example.org
Erik DahlChief Financial OfficerTel: +47 450 55 000Email: email@example.com
Ambaw BelletePresidentPhotocure Inc.,Tel: + 1-609-759-6515Email: firstname.lastname@example.org
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2018.
2. Bladder Cancer. American CancerSociety https://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2018.
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. Lotan Y, Kamat A M, et al. Key Concerns About the Current State of Bladder Cancer: Cancer Sept 2009; 4096-4103.