Regulatory Filings • Aug 11, 2023
Regulatory Filings
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Photocure Partner Asieris confirms Hexvix Phase III clinical trial in China meets endpoint
Press Release - Oslo, Norway, August 11, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today that the Hexvix[®] Phase III bridging trial in
China has successfully met its primary research endpoint.
The objective of this 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
(WLC) 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.
A total of 158 patients were enrolled in this study. The completed statistical
analysis results indicate that the study was successful and has achieved the
primary research endpoint, which was defined as; the proportion of patients who
have at least one tumor found by blue light but not by white light cystoscopy.
The results of the study will be submitted to the Chinese National Medical
Products Administration (NMPA) for a new drug application (NDA) in the coming
months.
"The clinical data of Hexvix further confirms its outstanding clinical
performance. We sincerely thank all the researchers and participants for their
dedication and efforts in advancing this clinical research." said Dr. Linda Wu,
Chief Development Officer of Asieris.
"This randomized clinical Phase III trial is the first being conducted with the
Richard Wolf HD "System Blue" BLC equipment to support a regulatory
registration. It will be exciting to see the impact of the improved image
quality on outcomes and the incremental results of BLC in patients needing a
transurethral resection of bladder tumors (TURBTs). We fully expect the Phase
III trial in China to complement the robust randomized controlled clinical
trials which support the international approvals and use of BLC and the benefits
of BLC over WLC alone.", said Anders Neijber, Photocure's Chief Medical Officer.
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 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/asieris-announces
-positive-phase-iii-bridging-trial-of-hexvix-a-diagnostic-drug-for-bladder
-cancer/
The trial is registered here: https://clinicaltrials.gov/ct2/show/NCT05600322
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
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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: [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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