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patients at 3 hospitals in Denmark is now published in Urology, The Gold
Journal.
Oslo, Norway, December 19, 2020, Photocure ASA (PHO:OSE), is pleased to announce
that the results from a new study with Blue Light Cystoscopy (BLCT) with Hexvix
and flexible cystoscopes are now published in Urology. Initial study findings
had been presented at the annual meeting of the Danish Urology Society on
November 16, 2019.
699 patients at 3 hospitals in Denmark were enrolled and randomized 1:1 to
either BLC with Hexvix with flexible cystoscopes or white light (WL) only
flexible cystoscopy at the time of first follow up after TURBT. Primary endpoint
was tumor recurrence within eight months from the randomization. Secondary
outcomes were numbers of procedures (TURBTs) in general anesthesia, time to the
first recurrence, differences in tumor size, risk of tumor progression, and
identification of carcinoma in situ.
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.
“It is very important to Photocure that the scientific community continues to
investigate the benefits of our solution for patients,” says Dan Schneider,
President and CEO of Photocure. “These first results showing reduced recurrence
after flexible Blue Light Cystoscopy with Hexvix in surveillance clearly
demonstrate the efficiency of the procedure and show how important it is to
include Hexvix in the surveillance and management of NMIBC patients.”
The study authors** 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. They explain the reduced recurrence rates
despite no difference in detection rates at randomization by the possibility of
early recurrences arising from small tumors not yet visible at the time of TURBT
or residual tumor. They assume that it could be a consequence of the fact that
by using BLC-guided flexible cystoscopy, it was possible to detect, and treat,
small additional tumors in patients where recurrence was already found at the
time of randomization.
Link to the study can be found here:
https://www.ncbi.nlm.nih.gov/pubmed/31843623
- TURBT: trans-urethral resection of bladder tumors
** Study Authors: Ditte Drejer, Anne-Louise Moltke, Anna Munk Nielsen, Gitte
Wrist Lam, Jørgen Bjerggaard Jensen
*** NMIBC: non-muscle invasive bladder cancer
About Bladder Cancer
Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000
prevalent cases, 550 000 new cases and almost 200 000 deaths annually in
2018[1].
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. In MIBC 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]
- Globocan. Incidence/mortality by population. Available
at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
- Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
- Sievert KD et al. World J Urol 2009;27:295-300
- Bladder Cancer. American Cancer
Society. https://www.cancer.org/cancer/bladder-cancer.html
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.
For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
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
Kilde
