OSLO, Norway, March 11, 2022 /PRNewswire/ -- Photocure ASA
(PHO: OSE), The Bladder Cancer Company, announces that
its partner Asieris Pharmaceuticals (688176.SH) has obtained
approval to conduct a real-world evidence study for Hexvix® in
Hainan, China, in addition to the
Phase III study approved last month.
Asieris announced today that the Hainan Provincial Medical
Products Administration, in accordance with advice from the
National Medical Products Administration Center for Drug Evaluation
(CDE), has approved the inclusion of Hexvix in the clinical
real-world evidence pilot study.
In January 2021, Asieris
Pharmaceuticals entered into a license agreement with Photocure,
obtaining exclusive rights to register and commercialize Hexvix in
mainland China and Taiwan. In December
2021, Hexvix was put into pilot use in the Boao Lecheng
International Medical Tourism Pilot Zone in Hainan Province with several patients
receiving the procedure to date.
The recommendation of combined use of Hexvix and blue light
cystoscopy (BLC®) for the improved management of
non-muscle invasive bladder cancer (NMIBC) has been included in all
major clinical practice guidelines, including Chinese Urological
Association Guideline. The present approval will allow Asieris to
capture real world Hexvix data from the Hainan Pilot in addition to
the results generated from the planned randomized controlled Phase
III trial in China.
Read Asieris' full media release
here: https://asieris.com/hexvix-has-obtained-cde-approval-to-carry-out-clinical-real-world-evidence-study/
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About Bladder Cancer
Bladder cancer ranks as the eighths most common cancer
worldwide with 1 720 000 prevalent cases (5-year
prevalence rate)1a, 573 000 new cases and more than
200 000 deaths annually in 2020.1b
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
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 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 and New
Zealand. 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
CONTACT:
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
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