Photocure ASA: Phase 3 study investigating Blue Light Flexible Cystoscopy with Cysview® in surveillance setting meets primar...
May 12 2017 - 2:29AM
Oslo, Norway, May 12th, 2017: Photocure ASA
(Photocure, PHO:OSE), today announced that a Phase 3 trial
investigating Blue Light Flexible Cystoscopy (BLFC(TM)) with
Cysview®/Hexvix® in the surveillance setting met the study primary
end point. Results from the study showed a highly statistically
significant improvement (p <0.0001) in the detection of patients
with recurrence of bladder cancer using BLFC with Cysview compared
to white light (WL) alone in patients with non-muscle invasive
bladder cancer (NMIBC) undergoing surveillance cystoscopy. Detailed
data from the study will be presented during a late-breaking
plenary abstract session on May 14th at the American Urological
Association, 2017 meeting.
"We are very pleased with
the strong results of this Phase 3 study and we appreciate the work
from investigators and patients who participated in the study.
There are approximately 1.4 million surveillance cystoscopies
performed in the US annually. These results represent an important
milestone for the potential improvement in the management of
patients. Later this year we intend to submit the data to the US
Food and Drug Administration (FDA) to seek a label expansion for
the indication of BLFC with Cysview in the surveillance setting."
said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure
ASA."
The Phase 3 study was a
prospective, open, comparative, within-patient controlled study,
including 304 patients enrolled at 17 academic institutions in the
US.
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
US1, 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 year4, 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 wall6. 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
treat7.
About Hexvix®/Cysview®
Hexvix® is a drug
that is taken up selectively by cancer cells in the bladder making
them glow bright pink during Blue Light Cystoscopy (BLC). BLC with
Hexvix® improves the
detection of tumors and leads to more complete resection, less
residual tumors and better management decisions (US)/ reduced risk
of recurrence and progression (Nordic).
Hexvix® is the
tradename in Europe, Cysview® in the 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.
For more information, please
contact:
Kjetil Hestdal
President and CEO, Photocure ASA
Tel: + 47 91319535
Email: kh@photocure.no
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
Emily Dell
Media contact
MCS Healthcare public relations
Tel: +1 732 589-0757
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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