Data on US Registry Study
for BLC(TM) with Cysview/Hexvix will also be Presented at
AUA
Oslo, Norway, April 26, 2017: Photocure ASA
(Photocure, PHO:OSE), today announced that results from the BLFC
with Cysview®/Hexvix® Phase 3 study will be presented during
a late-breaking plenary session at the American Urological
Association (AUA) Annual Meeting in Boston, Mass., May 12-16,
2017.
The late-breaking presentation will report results
from a prospective multi-center study, carried out at 17 centers in
the United States (US), on detection and impact on patient
management of Cysview in patients with non-muscle invasive bladder
cancer undergoing surveillance with a flexible cystoscopy to detect
the recurrence of bladder cancer.
New data will also be presented at AUA on a
prospective multicenter registry that has been established to study
the use of BLC(TM) (Blue Light Cystoscopy) with Cysview in the
operating room setting. This registry, which is the largest
non-muscle invasive bladder cancer registry in the US, continues to
add to the growing body of evidence of how BLC with Cysview can
improve the detection and management of bladder cancer in various
patient populations.
Key activities during the AUA 2017 meeting
include:
- Friday May 12:
- 1 to 3PM ET- BCEC
room 252 Poster session MP15-02: Blue Light Cystoscopy for the
diagnosis of Urothelial Bladder Cancer: results from a prospective
multicenter registry.
- Sunday May 14:
- 2 PM ET- BCEC
Ballroom: Surgical Techniques: Endoscopic Diagnosis and
Transurethral Resection of Superficial Bladder Cancer
- 3 PM ET- BCEC
Ballroom: PPTLBA-02: Late-Breaking Abstract - Blue Light Flexible
Cystoscopy (BLFC(TM)) with Hexaminolevulinate (HAL) and White Light
Flexible Cystoscopy: A Prospective, Comparative, Within-Patient
Controlled Multi-Center Phase 3 Study in the Detection of Bladder
Cancer during Surveillance.
http://www.jurology.com/article/S0022-5347(17)39292-3/abstract
- 1 PM to 5 PM ET -
Westin Waterfront, Douglass Room - Urological Society of American
Veterans (USAV) meeting and program. During the meeting, there will
be a panel discussion that will include BLC with Cysview® cases
from the Veterans Administration Medical Centers.
- Photocure will be exhibiting BLC(TM) with Cysview in Booth 1109 during the AUA
2017 meeting.
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 wall(6).
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 treat(7).
About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an optical
imaging agent used 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 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 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.
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.
For more information, please
contact:
Kjetil Hestdal
President and CEO, Photocure ASA
Tel: + 47 91319535
Email: mailto:kh@photocure.no
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
Media Relations:
Emily Dell
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: emilyd@mcspr.com
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.
This information is subject to the disclosure
requirements pursuant to section 5-12 of the Norwegian Securities
Trading Act.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq 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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