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Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Medicinteknik |
2023-10-12 10:32:49
Press Release - Oslo, Norway, October 12, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has today unveiled the results of its Hexvix[®] (APL-1706) Phase III
clinical trial in China. A presentation scheduled for today at the 43[rd]
Congress of the Société Internationale d'Urologie (SIU), confirms that, in a
Chinese population, Hexvix blue light cystoscopy (BLC[®]) outperformed white
light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases
of carcinoma in situ (CIS), and exhibited good tolerability.
The highly statistically significant results corroborate the findings of
Photocure's own randomized controlled trials (RCTs) that demonstrate the
clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection
and a favorable tolerability profile with no serious adverse events. Moreover,
Asieris' Phase III Hexvix trial is the first RCT conducted with high definition
4K blue light capital equipment.
"This randomized-controlled trial reinforces the benefits of BLC with Hexvix in
tumor detection over WLC alone with clinically convincing and statistically
significant results. This is on the backdrop of this Chinese trial being the
first RCT conducted with 4K high definition (HD) blue light equipment, making it
a valuable addition to the body of evidence already available on BLC with
Hexvix. It confirms that BLC with Hexvix is additive to WL also with high
quality HD imaging technology. We are pleased to see and acknowledge that our
partners at Asieris are driving innovation to support unmet needs in bladder
cancer", said Anders Neijber, Photocure's Chief Medical Officer.
The trial results have been selected as a "late-breaking abstract" at the 43[rd]
Congress of the Société Internationale d'Urologie (SIU) in Istanbul, Turkey,
October 11-14. The clinical study data will be presented today, October 12, in
the form of an Oral ePoster at 1:45pm local time.
The study is a prospective, self-controlled, multicenter Phase ? study intended
to evaluate 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 study
included a total of 158 patients, of which 114 underwent BLC. Of the 97 patients
diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional
lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114
patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%,
11/13) had additional CIS lesions detected under Hexvix BLC that were not found
under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions
in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in
the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.
Read Asieris' full media release here: https://asieris.com/asieris-unveiled
-results-of-its-phase-iii-clinical-study-for-apl-1706-an-imaging-drug-for
-diagnosis-or-surgery-of-bladder-cancer-at-the-siu-2023
-congress/ (https://asieris.com/asieris-unveiled-results-of-its-phase-iii
-clinical-study-for-apl-1706-an-imaging-drug-for-diagnosis-or-surgery-of-bladder
-cancer-at-the-siu-2023-congress/)
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.
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
may not comply with any legal process, regulation, registration or usage in the
country of your origin.
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