Oslo, Norway, January 29, 2024: Photocure ASA (OSE: PHO), The Bladder Cancer
Company, announces that its partner Asieris presented Phase III Clinical Study
and Real-World Research Data for Hexvix[®] (APL-1706) at the 2024 American
Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), on
Friday, January 26, 2024 in San Francisco.
The poster presentation (Abstract No. 593) "Blue Light Cystoscopy versus White
Light Cystoscopy for the Detection of Bladder Cancer in China: An Analysis of
Unpublished Clinical Trial and Real-World Data." included data from a recent
randomized controlled trial (RCT) as well as heretofore unpublished data from
the Hexvix real-world evidence study (RWS) in China.
The study included 158 patients enrolled in an RCT, of which 114 underwent Blue
Light Cystoscopy (BLC[®]) with Hexvix. 19 patients were included in the real
-world study (RWS). Among patients diagnosed with Ta, T1, or CIS, 42 out of 97
patients (43.3%) in the RCT and 4 out of 12 patients (33.3%) in the RWS had at
least one lesion detected with BLC but not with white light cystoscopy (WLC)
(p<0.0001).
Both the RCT and RWS confirmed that Blue Light Cystoscopy with Hexvix
demonstrated superior detection of bladder cancer in the Chinese population
compared to WLC, especially in the CIS population, with good tolerability.
Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global
biopharma company specializing in discovering, developing and commercializing
innovative drugs for the treatment of genitourinary tumors and other related
diseases. In January 2021, Asieris entered into a license agreement with
Photocure ASA to obtain the exclusive registration and commercialization rights
of Hexvix in mainland China and Taiwan. The new drug application (NDA) was
accepted by the National Medical Products Administration (NMPA) in November
2023.
See Asieris' full release here: https://asieris.com/asieris-releases-phase-iii
-clinical-study-and-real-world-research-data-for-apl-1706-a-bladder-cancer
-diagnosis-and-management-drug-at-the-2024-asco-gu/
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About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide - the 5th most
common in men - with 1 720 000 prevalent cases (5-year prevalence rate)[1a], 573
000 new cases and more than 200 000 deaths in 2020.[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 [January 2022].
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: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no