Photocure Partner Asieris announces 1[st] Patient enrolled in Hexvix Phase III trial in China

04 Nov 2022 10:36 CET

Press Release - Oslo, Norway, November 4, 2022: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today on the treatment of the first patient in the
Hexvix[®] phase III bridging trial.

The objective of the multicenter Phase III trial is to achieve regulatory
approval of Hexvix in Mainland China for use in patients with bladder cancer, by
investigating the detection rate and safety of Hexvix and blue light cystoscopy
(BLC[®]) versus white light cystoscopy in patients with non-muscle invasive
bladder cancer (NMIBC). The bridging trial is intended to confirm results from
prior clinical trials in a Chinese population. The clinical trial protocol
follows the protocols for registration studies in countries where Hexvix already
has market authorization. This study will be led by Peking Union Medical College
Hospital and the Chinese Academy of Medical Sciences.

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.

On December 26, 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 National
Medical Products Administration (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-completed-the-first-patient-dose-in-phase
-iii-trial/

The trial is registered here: https://clinicaltrials.gov/ct2/show/NCT05600322

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About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] 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

More information:
Access the news on Oslo Bors NewsWeb site

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