Photocure - Better patient outcomes for patients who received Hexvix®

Oslo, Norway, 30 April 2019: Photocure ASA announced today that a study published in World Journal of Urology, shows that patients who undergo bladder tumor resection with Blue Light Cystoscopy (BLC™) with Hexvix® exhibit improved outcomes even if they progress to disease stages which require radical cystectomy.

Beneficial long-term impact of BLC with Hexvix was published in an article by Renninger et al. in World Journal of Urology: The prognostic impact of hexaminolevulinate‑based bladder tumor resection in patients with primary non‑muscle invasive bladder cancer treated with radical cystectomy.

A retrospective study on 131 patients demonstrated improved cancer-specific (CSS) and overall (OS) 5-year survival for patients undergoing at least one TURBT (transurethral resection of bladder tumor) guided by BLC with Hexvix compared to white light cystoscopy (WLC) alone for non-muscle invasive cancer (NMIBC) prior to radical cystectomy (RC).

The 5-year CSS was 90.9% for the BLC group and 73.8% for the WLC group, and 5-year OS was 74.5% and 55.8% for BLC and WLC groups, respectively (p= 0.042, 0.038). Median follow-up was 38 months (IQR 13–56). The BLC-group was associated with a higher number of TURBTs prior to RC (p = 0.002) and administration of intravesical chemotherapy (p = 0.043).

In conclusion, the data suggest that the resection of NMIBC under BLC exerts a beneficial impact on outcomes of patients who will need to undergo RC during their course of disease. This finding may be due to improved risk stratification as the resection under BLC may allow more patients to be treated timely and adequately.

“These findings are extremely interesting as Photocure has not yet studied the impact of Hexvix on patients who progress to invasive disease. The authors’ assumptions that this might be due to improved risk stratification and more timely and adequate treatment is further strengthening the importance of better detection, more accurate diagnosis and complete resection of the tumors from the start”, says Dan Schneider, President and CEO of Photocure ASA.

About Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US.1,2  It is estimated that there will be 80,470 new cases of bladder cancer and 17,670 deaths due to bladder cancer in 2019.3 Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, and chronic bladder irritation and infections.4 Bladder cancer is one of the most expensive cancers to manage. It is estimated that upwards of $5.71 billion will be spent on bladder cancer in the US in the year 2020.5

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.4 NMIBC is in the inner layer of cells.3 These cancers are the most common (75%) of all bladder cancer cases and include the subtypes carcinoma in situ (CIS), Ta and T1 lesions.5 MIBC is when the cancer has grown into deeper layers of the bladder wall.2 These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.6 

About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC™ with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, fewer 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 Cysview® /Hexvix® 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://bit.ly/2wzqSQQ for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

About Photocure ASA
Photocure: 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). For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com

1 National Cancer Institute. SEER Stat Facts: Bladder Cancer 2017. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed on January 25, 2019.

2 American Cancer Society's (ACS) publication. Cancer Facts and Figures 2017: Special Section – Rare Cancers in Adults, and the ACS website. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed on March 25, 2019.

3 American Cancer Society. Key Statistics for Bladder Cancer 2019. https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html. Accessed on March 25, 2019.

4 American Cancer Society. Bladder Cancer. http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-additional. Accessed on March 25, 2019.

5 Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103(2):117-28.

6 Pulver D, Schoenberg M, Pulver F. Bladder Cancer: A Patient-Friendly Guide to Understanding Your Diagnosis and Treatment Options. Patient-Friendly Publishing; 2017.