Oslo, Norway, August 2, 2016 -- Photocure ASA announced today a new systematic review and meta-analysis on the impact of Blue Light Cystoscopy (BLC) with Hexvix® (Hexaminolevulinate) - versus White Light Cystoscopy (WLC) on progression in Non-Muscle Invasive Bladder Cancer (NMIBC). In this meta-analysis, the rate of progression was significantly lower in patients treated with BLC with Hexvix® versus WLC alone. The data was published online in the August issue of the peer-reviewed journal, Bladder Cancer.

This is the first meta-analysis to demonstrate the significant impact of BLC with Hexvix on the rate of cancer progression in patients with NMIBC. The results of this meta-analysis support the therapeutic potential of BLC with Hexvix in patients with NMIBC. The article shows the impact of BLC with Hexvix on progression of disease and adds to the existing clinical evidence that BLC with Hexvix-guided transurethral bladder tumor resection (TURBT) improves the detection of Ta-T1 non-muscle-invasive bladder cancer, carcinoma in situ (CIS) as well as reduction in rate of recurrence. 

The meta-analysis was based on studies of BLC with Hexvix versus white light cystoscopy in patients with NMIBC conducted between 2000 to 2016 and included a total of 294 studies of which five (4 randomized and 1 retrospective) were considered for final analysis. Of the 1,301 patients, 644 underwent BLC with Hexvix (49.5%) and 657 with WLC (50.5%):

  • Progression was found in 6.8% of BLC with Hexvix patients, (44) and 10.7% of WLC patients (70) which was highly significant ( p=0.01)
  • Progression-free survival was reported in a single study and was longer after BLC with Hexvix (p=0.05)

"This meta-analysis is especially exciting because it continues to show that BLC with Hexvix is the optimal treatment for bladder cancer patients. These significant clinical benefits are also the foundation of inclusion of BLC with Hexvix/Cysview in the majority of guidelines, including the recently released 2016 American Urological Association (AUA) and Society of Urologic Oncology (SUO) guideline. In addition to the National Comprehensive Cancer Network (NCCN), the European Association of Urology (EAU) and the National Institute for Health and Care Excellence (NICE) guideline in the UK," commented Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

About Bladder Cancer

Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease2. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20123. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

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. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer 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.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. 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 Photocure ASA

Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high-unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, and skin conditions. Our aim is to provide solutions, which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.
For more information, please contact:

Company contacts:

Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

Investor relations:

Trout International LLC
Lauren Williams
Tel: +44 20 3780 4972
Email: lwilliams@troutgroup.com

References

1. Gakis G, Fahmy O. 2016. Systematic Review and Meta-Analysis on the Impact of Hexaminolevulinate- Versus White-Light Guided Transurethral Bladder Tumor Resection on Progression in Non-Muscle Invasive Bladder Cancer. Bladder Cancer Journal, p: 293-300. In press.

2. Globocan. Incidence/mortality by population.  Available at: ttp://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015)

3. Leal et al, Eur Urol 2016; 69: 438-447

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Photocure ASA via Globenewswire
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