Regulatory Filings • Mar 28, 2024
Regulatory Filings
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New Publication: Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy
Press release - Oslo, Norway, March 28, 2024: Photocure ASA, The Bladder Cancer
Company, announces the publication of the study "Racial Difference in Detection
Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter
Registry" in the journal Cancers this week. This study aims to evaluate
heterogeneity in characteristics of blue light cystoscopy (BLC[®]) for detection
of malignant lesions among various races with non-muscle invasive bladder cancer
(NMIBC).
The study author Sia Daneshmand, MD and the participants of the BLC with Cysview
Study Group collected clinicopathologic information from adult patients
undergoing transurethral resection of bladder tumor (TURBT) or biopsy who were
enrolled in the multi-institutional BLC Cysview registry between April 2014 and
February 2021. The primary outcome was detection of any malignant lesion on
final pathology. Sensitivity, negative and positive predictive values for
detection of malignant lesions were calculated for BLC, white light cystoscopy
(WLC), and the combination of both modalities.
Overall, 2379 separate samples were identified from 1292 patients, of whom, 1095
(85%) were White/Caucasian, 96 (7%) Black/African American, 51 (4%) Asian and 50
(4%) Hispanic. The sensitivity of WLC, BLC, and the combination of both for any
malignant lesion was 88.7%, 95.8% and 99%, respectively, in the total cohort
(P<0.001). BLC sensitivity vs. WLC was most significantly pronounced in the
Asian population (96% vs 78%, P<0.001). In all races, the sensitivity of BLC was
significantly higher than WLC for detection of CIS (P<0.001). Also, the addition
of BLC to standard WLC increased the detection rate by 10% for any malignant
lesion in the total cohort. This rate increased to 18% in Asian patients.
Positive predictive value of BLC was also the highest in Asian population
(94.4%).
The authors conclude that regardless of race, BLC increased the detection of
bladder cancer when combined with WLC. However, the difference was more
pronounced in Asian patients: "Our study showed that regardless of race, BLC
increases the detection of bladder cancer when combined with WLC. These results
could identify differences in groups that will lead to improved treatment of
underserved minority populations. Further research is warranted to understand
the underlying etiology of these observations which may ultimately alter
interpretation of lesions detected by BLC," said Dr. Daneshmand.
Read the full publication here: https://www.mdpi.com/2072-6694/16/7/1268
About the Blue Light Cystoscopy with Cysview Registry
The U.S. Blue Light Cystoscopy with Cysview Registry (Clinical Trials:
NCT02660645) is a large prospective, longitudinal, real-world evidence study in
NMIBC* patients who have undergone TURBT** using Blue Light as an adjunct to
white light cystoscopy. The Registry study was established by Photocure in 2014
and is projected to enroll 4400 patients.
*NMIBC: Non-muscle invasive bladder cancer
**TURBT: Transurethral resection of bladder tumor
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA
About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a], 614
000 new cases and more than 220 000 deaths in 2022.[1b]
Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate with up to 61% in year one and up to 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]
[1 ]Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: https://gco.iarc.fr/today, accessed [February 2024].
[2 ]Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
[3 ]Sievert KD et al. World J Urol 2009;27:295-300
[4 ]Bladder Cancer. American Cancer Society.
https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the
bladder, making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC
with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves
the detection of tumors and leads to more complete resection, fewer residual
tumors, and better management decisions.
Cysview[ ]is the tradename in the U.S. and Canada, Hexvix[ ]is the tradename in
all other markets. Photocure is commercializing Cysview/Hexvix directly in the
U.S. and Europe and has strategic partnerships for the commercialization of
Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer
to https://photocure.com/partners/our-partners for further information on our
commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
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, www.cysview.com
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
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