Positive data from Phase 3 US Blue Light Cystoscopy with Cysview® study presented at AUA 2017 meeting in Boston

PR Newswire

PRINCETON, N.J., May 14, 2017 /PRNewswire/ -- Photocure Inc., (Photocure, PHO: OSE), today announced that new Phase 3 study results with Blue Light Flexible Cystoscopy (BLFC™) with Hexvix^®/Cysview^®^*were presented during a late-breaking plenary session at the American Urological Association (AUA) Annual Meeting in Boston, Massachusetts on Sunday May 14^th. The study showed that BLFC with Cysview detected bladder cancer recurrence in 21.5% of the patients undergoing surveillance cystoscopy that otherwise would have been missed with white light (WL) alone, which is highly significant (p<0.0001). Of note, the study showed that nine out of twenty-six patients (34.6%) with flat, more aggressive high grade lesions (carcinoma in situ; CIS) were diagnosed using confirmatory Blue Light Cystoscopy with Cysview alone and not WL (p<0.0001). The study also showed that there was no increase in the rate of related adverse events after repeated administration of Cysview in bladder cancer patients undergoing cystoscopy examination.

The study was a prospective, open, comparative, within-patient controlled study, included 304 patients with non-muscle invasive bladder cancer (NMIBC) enrolled at 17 academic institutions in the US. In the study BLFC with Cysview was used with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System.

"This study shows that BLFC can provide a significant advantage for patients in terms of early detection of tumor recurrence which may improve treatment and therefore lead to better outcomes," says one of the lead investigators J. Stephen Jones, MD, president of Cleveland Clinic Regional Hospitals and Family Health Centers. "92.7% of the patients said it was worthwhile to undergo BLFC and 93.8% said that they would do it again. The results of the study show that BLFC will play a significant role in outpatient management of bladder cancer."

"We are very pleased with the strong results of this Phase 3 study and intend to submit the data to the US Food and Drug Administration (FDA) to seek approval of BLFC with Cysview^® in the surveillance setting in the US, and an expansion of the indication to include CIS," says Ambaw Bellete, President, Photocure Inc. "We are committed to working with the FDA to bring this important tool to the US market so that physicians and patients can benefit from potentially better and more cost-effective management of the disease."

Click here for a link to the late breaking abstract: http://bit.ly/BLFCC-LateBreaking.

In addition, on May 12th at the AUA annual meeting, data from the largest Bladder Cancer Registry Study in the US was presented at a Poster session "BLUE LIGHT CYSTOSCOPY FOR THE DIAGNOSIS OF UROTHELIAL BLADDER CANCER: RESULTS FROM A PROSPECTIVE MULTICENTER REGISTRY." The results from 9 centers included 1325 lesions, from 517 procedures in 426 patients. The conclusion of the study was that BLC significantly increased the detection of CIS and papillary lesions over WLC alone and can result in upstaging and upgrading in about 13% of patients, which can affect patient outcomes.

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. 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 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 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^® 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 (US)/ reduced risk of recurrence and progression (Nordic).

Hexvix^® is the tradename in Europe, Cysview^® in the 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 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.

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.

For more information, please contact:

Kjetil Hestdal
President and CEO, Photocure ASA
Tel: + 47 91319535
Email: [email protected]

Erik DahlChief Financial Officer
Tel: +47 450 55 000
Email: [email protected]

Emily DellMedia contact
MCS Healthcare public relations
Tel: +1 732 589-0757
Email: [email protected]

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.