Earnings Release • Oct 23, 2017
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Photocure ASA: BLC(TM) with Cysview®/Hexvix® real World Data presented at the Société Internationale d'Urologie 2017 Annual meeting
Oslo, Norway, October 23, 2017 Photocure ASA announced that new data
from the Blue Light Cystoscopy (BLC(TM)) with Cysview®/Hexvix®
registry study were presented at the 37th Société Internationale
d'Urologie (SIU) Annual meeting, October 19-22, Lisbon, Portugal.
Data from the registry study, which is the largest US Bladder Cancer
Registry Study, showed that BLC with Cysview resulted in an
upstaging or upgrading of tumor with change in patient management in
13% of patients. The addition of BLC with Cysview to standard WLC
increased the detection rate by 12% for any papillary and 44% for
the more aggressive CIS (Carcinoma in Situ) bladder cancer lesions.
The BLC with Cysview Bladder Cancer Registry Study is a prospective
multicenter registry that included patients undergoing Transurethral
Resection of Bladder Tumors (TURBT) from nine sites. The results
presented included 533 patients who underwent 641 BLC with Cysview
procedures, resulting in the identification of 1632 lesions.
"In this study, BLC(TM) with Cysview significantly increases
detection rates of CIS and high-grade lesions compared to WLC alone.
This in turn, resulted in a change in management for 13% of the
patients, which can lead to an improvement in outcomes for these
patients" 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.
Dr. Daneshmand also presented a Video Abstract which highlighted
different scenarios producing false-positive data. The video
referenced simple techniques to avoid false-positives (FP) and noted
that reported FP rates of BLC decrease with experience and
recognition of these scenarios.
"This registry study demonstrates how BLC with Cysview/Hexvix is
changing clinical outcomes, and provides more real world Data to
further support its clinical use," said Kjetil Hestdal, M.D., Ph.D.,
President and CEO, Photocure ASA.
Link to congress scientific program: http://bit.ly/2yIbv7N
About Bladder Cancer
Bladder cancer ranks as the ninth most common cancer worldwide with
430 000 new cases and more than 165 000 deaths annually. Approx. 75%
of all bladder cancer cases occur in men1. It has a high recurrence
rate with an average of 61% in year one and 78% over five years2.
Bladder cancer has the highest lifetime treatment costs per patient
of all cancers3.
Bladder cancer is a costly, potentially progressive disease for
which patients have to undergo multiple cystoscopies due to the high
risk of recurrence. 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
remains in the inner layer of cells lining the bladder. 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.4
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer
cells in the bladder making them glow bright pink during Blue Light
Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® 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 to
https://www.photocure.com/Partnering-with-Photocure/Our-partners for
further information on our commercial partners.
About Photocure
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). More information about Photocure is available at
www.photocure.com, www.hexvix.com, www.cysview.com
Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: [email protected]
Erik Dahl, Chief Financial Officer
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
2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW,
Compérat E, et al. EAU Guidelines on non-muscle-invasive bladder
cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40. 3.
Sievert KD et al. World J Urol 2009;27:295-300 4. Bladder Cancer.
American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-
pdf.pdf. Accessed April 2016
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