OSLO, Norway, July 6, 2023 /PRNewswire/ -- Photocure ASA
(OSE: PHO), the Bladder Cancer Company, announces that its
partner Asieris Pharmaceuticals (SSE: 688176) has
communicated today that it has completed patient enrollment for the
Hexvix® Phase III bridging trial.
The objective of the multicenter Phase III trial is to support
regulatory approval of Hexvix in Mainland China. The bridging trial
is intended to confirm results from prior clinical trials regarding
the safety and detection benefits of blue light cystoscopy (BLC®)
with Hexvix compared to white light cystoscopy in the diagnosis of
non-muscle invasive bladder cancer (NMIBC) in a Chinese population.
The clinical trial follows the same protocols for registration
studies in countries where Hexvix already has market
authorization.
This study is being led by Peking Union Medical College Hospital
and the Chinese Academy of Medical Sciences. Professor Li Hanzhong,
head of the Department of Surgery at Peking Union Medical College
Hospital, is serving as the Principal Investigator, leading a team
of top experts in the field of bladder cancer in China to carry out this study. Asieris plans
to file a new drug application with the National Medical Products
Administration (NMPA) in the future, pending clinical trial
progress and meaningful data.
Asieris Pharmaceuticals 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.
In December 2021, 2021, Hexvix
obtained initial clinical use in the Boao Lecheng International
Medical Tourism Pilot Zone in Hainan
Province, when the first patient received blue light
cystoscopy with Hexvix at the Hainan General Hospital. The phase
III clinical trial obtained approval from the NMPA in the first
quarter of 2022 and Hexvix was subsequently included in the
real-world clinical data pilot program.
Read Asieris' full media release
here: https://asieris.com/hexvix-a-diagnostic-drug-for-bladder-cancer-of-asieris-has-completed-the-phase-iii-bridging-trial-enrollment/
The trial is registered
here: https://clinicaltrials.gov/ct2/show/NCT05600322
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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
The following files are available for download:
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https://mb.cision.com/Main/17498/3801061/2176764.pdf
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