Oslo, Norway, December 8, 2017: Photocure ASA
(Photocure, PHO: OSE), today announced that the official Journal of
the American Urologic Association (AUA), the Journal of Urology,
published the BLFCC Efficacy results from a Phase 3
trial investigating the efficacy of Blue Light Cystoscopy
(BLC(TM)) with
Cysview® for
surveillance with a flexible cystoscope. In 20.6 percent of
patient's recurrence was seen only with BLC
with Cysview and missed with WLC (p<0.0001).
Out of the 304 patients in the study, 103 were
referred to the Operating Room for suspicion of recurrent bladder
cancer. Of these, 63 patients were confirmed as having malignant
tumors. Forty one percent of the patients with malignant
tumors were confirmed as having CIS (Carcinoma in Situ), the most
aggressive and difficult to detect and treat type of non-muscle
invasive bladder cancer (NMIBC). Importantly, 34% of these
patients were detected only with BLC with Cysview (p<0.0001) but
were missed with WLC.
"This study, which despite being carried out in
centers with bladder cancer and BLC expertise, showed that blue
light flexible cystoscopy significantly (p<0.0001) improves
detection of patients with recurrent bladder cancer. BLC
detects lesions, including CIS that were missed with WLC
alone. The detection of additional tumors in the surveillance
setting may have profound effects on progression rates through
earlier diagnosis of high risk lesions which would have been
otherwise missed with WLC. The results of this study confirm
the role for BLC in the management of intermediate and high risk
bladder cancer patients," says J. Stephen Jones, MD, president of Cleveland Clinic
Regional Hospitals and Family Health Centers.
"This publication reports the data included
in the supplemental NDA submitted to the FDA to get approval for
the use of BLC with Cysview in the surveillance setting with
flexible cystoscopy. We look forward to bringing this technology to
bladder cancer patients and their health care providers for the
follow-up of NMIBC in the office setting," said Kjetil Hestdal,
M.D., Ph.D., President and CEO, Photocure ASA."
The study is a prospective, open, comparative
within-patient controlled study of 304 patients with high risk of
recurrence enrolled at 17 academic centers 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 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.
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. 2 NMIBC
remains in the inner layer of cells lining the bladder. These
cancers are the most common (70%) 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. 2
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: kh@photcure.no
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
References:
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.
All trademarks mentioned in this
release are protected by law and are registered trademarks of
Photocure ASA
This press release may contain
product details and information which are not valid, or a product
is not accessible, in your country. Please be aware that Photocure
does not take any responsibility for accessing such information
which may not comply with any legal process, regulation,
registration or usage in the country of your origin.
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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