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presented at Danish Urological Society meeting.
Oslo, Norway November 18, 2019, Photocure ASA (PHO:OSE), is pleased to announce
that results from new studies with flexible Blue Light Cystoscopy (BLCT) with
Hexvix were presented at the annual meeting of the Danish Urology Society on
Saturday, November 16.
Results from a randomized controlled study in 699 patients from three urological
departments in Denmark was presented. Patients were enrolled and randomized 1:1
to either flexible BLC with Hexvix or white light (WL) only cystoscopy at the
time of first follow up after TURBT. Primary endpoint was tumor recurrence
within eight months from the randomization. A total of 351 patients were
allocated to the flexible BLC, and 348 to the control group). Throughout the
following 8 months after randomization, only 117 patients in the BLC group had
at least one tumor recurrence compared to 143 patients in the control group (P=
0.049). Odds ratio of 0.67 (P= 0.02, 95% CI: 0.48-0.95) correlates with a tumor
reduction of 33% in favor of the BLC group.
The study authors (Ditte Drejer, Anne-Louise Moltke, Anna Munk Nielsen, Gitte
Wrist Lam, Jørgen Bjerggaard Jensen) conclude that use of BLC in the first
routine surveillance cystoscopy after TURBT for NMIBC** reduces subsequent risk
of tumor recurrence compared to WL cystoscopy alone.
The study abstract can be found here (p. 48):
http://urologi.dk/sites/default/files/begivenheder/dus_bog_final_version_0.pdf
Experiences with flexible BLC with Hexvix in 119 patients at Lillebælt hospital
in Denmark were also presented. Flexible BLC with Hexvix was introduced to
replace procedures traditionally performed with rigid cystoscopes under general
anesthesia; in control after intravesical treatment in high-risk patients, in
patients with positive cytology and negative WL cystoscopy, in suspicious
mucosal abnormalities under WL and in treatment of small recurrences.
The authors (Karen Spanggaard, Karsten Zieger, Gitte Kissow, Louise Fauerholt
Øbro) conclude that flexible BLC and the possibility to biopsy in gel anesthesia
was well tolerated and patient satisfaction was high. For most patients, BLC
enabled treatment to be completed in the office. BLC was found to increase
detection of urothelial disease and to add valuable information to WL cystoscopy
and cytology.
The study abstract can be found here (p. 47):
http://urologi.dk/sites/default/files/begivenheder/dus_bog_final_version_0.pdf
- TURBT: trans-urethral resection of bladder tumors
** NMIBC: non-muscle invasive bladder cancer
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 men[1]. It has a high recurrence rate with an average of 61% in
year one and 78% over five years[2]. Bladder cancer has the highest lifetime
treatment costs per patient of all cancers[3].
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[®] (hexaminolevulinate HCl)
Hexvix[®]/Cysview[®] is a drug that is selectively taken up by tumor cells in
the bladder making them glow bright pink during Blue Light Cystoscopy (BLC[TM]).
BLCT with Hexvix[®] /Cysview[®] improves the detection of tumors and leads to
more complete resection, fewer 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 Cysview[®] / Hexvix[®] 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://bit.ly/2wzqSQQ for further information on our
commercial partners.
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.
References
-
Globocan. Incidence/mortality by population. Available
at: http://globocan.iarc.fr/Default.aspx
-
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.
-
Sievert KD et al. World J Urol 2009;27:295-300
-
Bladder Cancer. American Cancer Society.
https://www.cancer.org/cancer/bladder-cancer.html
For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
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