Regulatory Filings • Mar 23, 2015
Regulatory Filings
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PHOTOCURE: HEXVIX® BLUE-LIGHT FLEXIBLE CYSTOSCOPY IN THE OUTPATIENT SETTING: PRESENTATION AT EAU ANNUAL MEETING
Hexvix blue-light flexible cystoscopy allows for better identification and
management of recurrent low-grade tumors in the outpatient setting, providing
clinical, patient, and economic benefits.
Oslo, Norway, March 23, 2015: Photocure ASA (OSE: PHO), a specialty
pharmaceutical company focused on photodynamic technologies in dermatology and
cancer, reports that Norwegian investigators have presented positive case
studies with Hexvix blue-light flexible cystoscopy in the outpatient setting at
the European Association of Urology (EAU) annual meeting in Madrid, Spain, on
March 22nd, 2015. The EAU meeting is Europe's largest annual event showcasing
the latest and most relevant knowledge in urology, with more than 14,000
delegates and exhibitors from over 100 countries.
The research, presented as five video case presentations by Dr. Reza Zare, Head
of Urology at Bærum Hospital, Norway, shows how Hexvix blue-light flexible
cystoscopy achieved high-quality images, with improved visibility of tumors
compared with standard white-light flexible cystoscopy alone. Hexvix blue-light
flexible cystoscopy was convenient and well tolerated, with a high level of
patient acceptance. The technology allowed for biopsies of suspicious areas of
the bladder, and small tumors removed in outpatient procedures.
Dr. Zare explained the economical and practical importance of these findings:
"By securing improved detection and limiting the number of patients who have to
be referred to the operating room to have their tumors removed, we can avoid the
need for general anesthesia and overnight hospital stays, thus taking the
pressure off hospital services and reducing the burden of disease on patients."
Bladder cancer is the fifth most common cancer in Europe, accounting for an
estimated 124,000 new cases and more than 40,000 deaths in 2012.(1) Bladder
cancer has a high recurrence rate - up to 78% of patients experience recurrence
within 5 years of their initial diagnosis(2 )- causing patients to require
lifelong surveillance. While Hexvix blue-light cystoscopy using rigid
cystoscopes, as an adjunct to white-light cystoscopy, is already a standard of
care in the operating room, with proven ability to improve detection and
management of non-muscle-invasive bladder cancer compared with white-light
cystoscopy alone(3) , Hexvix blue-light flexible cystoscopy is becoming
increasingly feasible. Improvements in equipment allow for early detection of
recurrent tumors and low-grade tumors to be removed in the outpatient setting
without the need for referral to the operating room. In addition, early follow-
up of patients with blue-light flexible cystoscopy following surgical removal of
the tumor is likely to offer advantages in terms of improved detection of
residual tumor and reduced recurrence.
Per-Uno Malmström, Professor of Urology at Uppsala University, Sweden, said:
"Early and accurate bladder cancer detection and removal can reduce the risk of
recurrence and avoid the need for frequent follow-up visits. With outpatient
follow up of patients using blue-light cystoscopy with Hexvix, tumors can be
detected at an early stage, and small or flat lesions can be removed without
delay, which can be expected to improve the long-term prospects for patients."
Fred Witjes, Chair of Oncological Urology at Radboud University, Netherlands,
said: "In 2014, the European expert consensus panel updated our recommendations,
emphasizing the potential benefits of blue-light flexible cystoscopy with
advances in equipment, which will help to improve patients' experience of
bladder cancer care. I am delighted to see that these advances are being
achieved, as witnessed by the experiences of Dr. Zare and his colleagues using
Hexvix in the outpatient setting."
More information on the EAU 2015 meeting can be found here:
http://eaumadrid2015.uroweb.org/the-congress.
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: [email protected]
CFO Erik Dahl
Tel: +47 450 55 000, Email: [email protected]
References
1. Globocan. Incidence/mortality by population. Available at:
http://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015).
2. Sylvester RJ, van der Meijden AP, Oosterlinck W et al. Predicting recurrence
and progression in individual patients with stage Ta T1 bladder cancer using
EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials.
Eur Urol 2006; 49: 466-475.
3. Burger M, Grossman HB, Droller M et al. Photodynamic diagnosis of non-muscle-
invasive bladder cancer with hexaminolevulinate cystoscopy: a meta-analysis of
detection and recurrence based on raw data. Eur Urol 2013; 64: 846-854.
About Photocure ASA
Photocure ASA, 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 in disease areas with
high unmet medical need, such as bladder cancer, HPV and precancerous cervical
lesions, colorectal cancer and skin conditions. Our aim is to provide solutions
that 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.
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(®)/Cysview(®) is
approved in Europe and the USA.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1905063]
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