Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection

Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy.
Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis.
Perspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway.
Implications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care.
Additionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.

Start Date01 Jan 2026

Sponsor / Collaborator-

NCT06525571

/ RecruitingPhase 3IIT

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

Start Date20 Dec 2024

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT05600322

/ CompletedPhase 3

A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

Start Date03 Nov 2022

Sponsor / Collaborator

Photocure ASA

[+2]

100 Clinical Results associated with Hexaminolevulinate Hydrochloride

100 Translational Medicine associated with Hexaminolevulinate Hydrochloride

100 Patents (Medical) associated with Hexaminolevulinate Hydrochloride

312

Literatures (Medical) associated with Hexaminolevulinate Hydrochloride

01 Apr 2025·European Urology

Re: Immune Contexture Changes Following Blue Light Cystoscopy with Hexaminolevulinate in Bladder Cancer

Article

Author: Gakis, Georgios

01 Apr 2025·Photodiagnosis and Photodynamic Therapy

Bibliometric analysis of photodynamic research in bladder cancer: Trends and future directions

Review

Author: Sheng, Zhaoyang ; Zeng, Shuxiong ; Xu, Yang ; Zhang, Zhensheng ; Gao, Hongliang ; Xu, Jinshan ; Chen, Guanghua ; Xu, Xi

BACKGROUNDRecent years have seen the use of photodynamic technologies concerning the detection and therapy of bladder cancer (BC) due to their rapid development and well-established therapeutic impact. However, a thorough analysis and bibliometric assessment of photodynamic technologies publishing trends in BC has not been completed yet.METHODSRetrieving bibliographies from the Web of Science Core Collection limited the publication date to December 31, 2023, from January 1, 2004. We used VOSviewer (Version 1.6.19) and CiteSpace (Version 6.4 R1) for both statistical and visualization analysis.RESULTSWe selected a total of 870 documents for analysis. The yearly publication findings show notable upward patterns over the last two decades. The Kochi Medical School in Japan was the most productive school, while the USA was the most productive nation. Japanese researcher Inoue Keiji published the highest number of photodynamic -related articles in BC. The most quoted and prolific journals were the Photodynamic Therapy and Photodiagnosis. According to the keyword analysis, the terms "cystoscopy," "carcinoma in situ," "drug delivery," "follow-up," "hexaminolevulinate," and "impact" are all relatively recent and hot field.CONCLUSIONSOur investigation produced a bibliometric outcome for the field, potentially opening up new research opportunities. We suggest that future research concentrate on in-situ carcinoma identification, photosensitizer invention, medication delivery enhancement, and photodynamic technology follow-up in BC.

01 Feb 2025·Photodiagnosis and Photodynamic Therapy

Long-term outcome of photodynamic therapy with hexyl aminolevulinate, 5-aminolevulinic acid nanoemulsion and methyl aminolevulinate for low-risk Basal Cell Carcinomas

Article

Author: Grönroos, M ; Snellman, E ; Salmivuori, M ; Räsänen, J ; Tani, T ; Neittaanmäki, N

BACKGROUNDNon-surgical treatments are cost-effective options for low-risk basal cell carcinomas (BCCs) i.e. superficial or small nodular BCCs located outside the high-risk locations. Hexyl aminolevulinate (HAL) and 5-aminolevulinic acid nanoemulsion (BF-200 ALA) with enhanced penetration depth enables the use of lower concentrations compared to methylaminolevulinate (MAL) in photodynamic therapy (PDT). We have previously reported comparable short-term efficacies for MAL 16 %, BF-200 ALA 7.8 % and HAL 2 % in PDT of low-risk BCC, and here we report the long-term results.OBJECTIVESThe goal of this trial was to compare long-term outcomes of HAL and BF-200 ALA, compared to MAL in PDT of low-risk BCCs.METHODSNinety-eight histologically verified low-risk BCCs on the trunk or extremities were included and randomized into three arms to receive PDT in two sessions with MAL, BF-200 ALA or HAL. A blinded dermatologist assessed the response, cosmetic outcome, and obtained biopsies for histological verification at three months, one year and five years. Histologically verified non-responsive lesions were excised. Patients' satisfaction with the treatment was also queried.RESULTSAccording to intention-to-treat (ITT) analyses, the cumulative response rate at one year was 90.6 % for MAL, 81.3 % for BF-200 ALA, and 75.8 % for HAL, and correspondingly at five years 71.9 %, 54.6 % and 60.6 %. There were no statistically significant differences between interventions and comparator. The overall cumulative response rate for PDT was 82.5 % at one year and 62.2 % at five, and 48.6 % of the treatment failures were recorded at five years. The recurrent lesions were excised as second line treatment. No aggressive subtypes were reported, with only superficial or nodular growth in the final histopathological report. There were no significant differences in cosmetic outcome or patient satisfaction.CONCLUSIONSThis trial shows that HAL has potential for dermatological PDT. However, the long-term efficacy of PDT in the treatment of low-risk BCCs remains rather low.

News (Medical) associated with Hexaminolevulinate Hydrochloride

29 Apr 2025

·www.prnewswire.com

Bladder Cancer presentations at AUA2025: Blue Light Cystoscopy improves risk stratification and informed decision making

OSLO, Norway, April 29, 2025 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces four abstract presentations at the AUA 2025, highlighting the benefits of Blue Light Cystoscopy (BLC®), notably its impact on management of the disease, improved risk stratification and therefore the ability of the BLC procedure to help urologists and patients make well-informed decisions. The American Urological Association Annual Congress 2025 was held April 26-28, at the Venetian Convention & Expo Center in Las Vegas, NV, USA. Three abstracts were presented from Photocure's U.S. Blue Light Cystoscopy with Cysview Registry, a large multicenter bladder cancer patient registry of real-world data, established by Photocure in 2014 and projected to enroll 4,400 patients. In addition, the study protocol of a randomized controlled non-inferiority trial comparing a multidisciplinary approach including PDD-guided primary TURBT to reduce the patients' burden of second resection including a total of 327 patients has been presented. This investigator-initiated trial is supported by Photocure. The abstract sessions on Saturday, April 26: "Upstaging and Risk Migration with BLC for NMIBC: Results from a prospective multicenter registry" by Alireza Ghoreifi, Duke University The study looked at 2,854 NMIBC* patients from the US Blue Light Cystoscopy with Cysview Registry. A total of 201 (7%) patients had at least one malignant lesion detected exclusively by BLC while having a negative WLC. These lesions (335 in total) included carcinoma in-situ (CIS) (145; 43%), low-grade Ta (53; 16%), high-grade Ta (95; 28%), high-grade T1 (37; 11%), and high-grade T2 (5; 1%). As a result of BLC-enhanced detection, the rate of upgrading or upstaging to a more advanced tumor using BLC was 9.3%. The authors concluded that resulting changes in grade/stage could impact patient management, such as the appropriate administration of intravesical therapy, duration of therapy, and when to perform radical cystectomy. The results are expected to form the basis for further studies on how Blue Light Cystoscopy can support precision diagnostics and improve patient management in NMIBC. Read the abstract: "Predicting Recurrence and Progression in Contemporary Patients with NMIBC Undergoing Blue Light Cystoscopy-Aided Transurethral Resection of Bladder Tumor" by Boris Gershman, Harvard University, Beth Israel Deaconess Medical Center Although blue light cystoscopy (BLC) is recommended by clinical practice guidelines to reduce recurrence, predictive models for patients undergoing BLC are lacking. The authors developed predictive models for recurrence and progression in patients treated with BLC using 1109 patients. Median age at diagnosis was 71 years, and 198 (18%) patients were female. Tumor stage was Ta in 658 (60%), T1 in 241 (22%), and pure CIS in 210 (19%) patients. 759 (71%) patients had high-grade tumors, and 324 (29%) patients had multifocal disease. Median follow-up for relapse-free survival (RFS) and progression-free survival (PFS) was 18, and 24 months, respectively, during which time 360 recurrence and 79 progression events occurred. Results showed a greater number of tumors (unit HR 1.09), and recurrent tumor status (HR 1.32) were associated with increased risk of recurrence, while pure CIS (HR 0.69) and receipt of perioperative intravesical chemotherapy (HR 0.76) were associated with decreased risk of recurrence. In contrast, higher tumor stage (HR 3.88 for T1; HR 3.69 for T1+CIS) and lymphovascular invasion (HR 3.88) were associated with increased risks of progression. The impact of the data is that these models reflect contemporary treatment standards and can inform personalized, risk-adapted management of NMIBC. Read the abstract: "Performance of the EORTC and CUETO Risk Prediction Models in Contemporary Patients Undergoing Transurethral Resection of Bladder Tumor with Blue Light Cystoscopy" by Boris Gershman, Harvard University, Beth Israel Deaconess Medical Center In a companion study, the performance of the BLC recurrence/ progression model was compared against EORTC and CUETO, a pair of widely recognized risk tools for predicting recurrence and progression in non-muscle invasive bladder cancer (NMIBC). Out of total of 899 patients included from the BLC Registry, Ta was found in 658 (73%) patients and T1 in 241 (27%) patients, and concomitant CIS was present in 116 (13%) patients. Median follow-up for RFS and PFS was 18 and 24 months, respectively. The discrimination of the EORTC model was c=0.59 for RFS and c=0.67 for PFS, while for the CUETO model it was c=0.53 for RFS and c=0.72 for PFS. Thus, overall, in a contemporary cohort of patients undergoing BLC-TURBT, the EORTC and CUETO models demonstrated poor performance in predicting RFS and PFS. Dr. Boris Gershman, principal author of these two abstracts commented: "Accurate prediction of recurrence and progression risk is essential for the management of non-muscle invasive bladder cancer. However, the established EORTC and CUETO risk models demonstrated poor performance forecasting these outcomes among contemporary patients receiving a TURBT with blue light cystoscopy. We therefore used the multi-institutional Blue Light Cystoscopy Registry to develop modern predictive models for recurrence and progression in patients treated with BLC. Such tools as these reflect contemporary treatment paradigms, and can inform the personalized, risk-adapted management of NMIBC." "At AUA and EAU 2025 congresses we have seen important expert alignment these past weeks on the importance of early and accurate precision diagnosis in bladder cancer, and the role of blue light cystoscopy. Accurate diagnosis and risk stratification based on staging, grading impacts treatment decisions. It matters increasingly, the more advanced individualized treatment options a urologist is able to offer for the management of their patients' bladder cancer," said Anders Neijber, Photocure's Chief Medical Officer. Read the abstract: On Monday, April 28, in "Clinical Trials in Progress": "VI-RADS followed by Photodynamic Transurethral Resection of Non-muscle Invasive Bladder Cancer versus White-light Conventional and Second Resection: The CUT-LESS Randomized Trial" by Francesco del Guidici et al. from "Sapienza" University of Rome, Italy The CUT-less trial aims to evaluate if second resection can be safely omitted in selected patients by combining cross-sectional imaging and PDD-guided primary TURB in order to reduce the burden of early repeated TURB for the patient. This randomized controlled non-inferiority trial compares the short-term recurrence rates when combining preoperative staging using multiparametic magnetic resonance imaging (mpMRI) Vesical Imaging-Reporting and Data System (VI-RADS) and PDD-guided primary TURB vs. mpMRI Vi-RADs and white-light TURB only followed by second resection in patients which are candidates for second resection in NMIBC. This study will include a total of 327 patients. Secondary endpoints include comparative evaluation of mid- and long-term recurrence and progression rates, health-related quality of life, and health-economic cost-benefit analysis. Read the abstract: Beyond this groundbreaking volume and value of new data related to BLC, Photocure provided congress attendees with hands-on experience in the blue light cystoscopy with Cysview procedure on its booth that featured a Fortec Mobile Equipment Demo of the Saphira HD equipment and rental option. In addition, other tech talks and expert sessions by equipment partners featured more aspects of blue light cystoscopy. *NMIBC: Non-muscle invasive bladder cancer **TURBT: trans-urethral resection of bladder tumors 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 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b 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: , accessed [February 2024]. 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. 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 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 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] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision . The following files are available for download: SOURCE Photocure WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

18 Apr 2025

·www.prnewswire.com

Asieris Pharmaceuticals Releases 2024 Annual Report, with Revenue Exceeding RMB 200M in 1st Year of Commercialization and Innovative Portfolio Accelerating Toward Launch

SHANGHAI, April 18, 2025 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2024 Annual Report, highlighting a bold and determined journey forward. With a specialty pharma strategy and operational efficiency, the company exceeded its commercialization targets and advanced its innovative products — APL-1702 and APL-1706 (Hexvix®) — toward market launch. R&D efforts also gained strong momentum, with 12 products in the pipeline and 16 ongoing research projects. As of the end of the reporting period, Asieris held approximately RMB 1.89 billion in cash, cash equivalents, and trading financial assets, providing a solid foundation for continued growth. Revenue Tops RMB 200M in 1st Year of Commercialization, with the specialized commercialization platform poised for action 2024 marked Asieris' first full year of commercialization. The company has made strides in refining market strategies and ensuring high-quality execution, while effectively managing costs and expenses. Asieris posted operating revenue of RMB 202 million, demonstrating robust growth and successfully reaching break-even targets in commercial operations. During the reporting period, the company's two commercialized products, Ouyoubi and Dipaite, saw strong uptake, reaching over 1,000 and 500 target hospitals respectively. Sales grew rapidly, with Ouyoubi capturing 27% of the neratinib tablet market and Dipaite securing 12% of the pazopanib tablet market. To further strengthen its presence in key focus areas, the company introduced multiple products and established sales partnerships in women's health and genitourinary (GU) tumors. In March 2025, it licensed-in the eribulin mesylate injection, a novel microtubule inhibitor for the treatment of advanced breast cancer. With this addition, the company's breast cancer portfolio now covers both early and late-stage disease. To further enhance commercialization efficiency, the company has launched its Commercial Operation 2.0 — building on past successes to create a leaner, more agile operating model. Key initiatives include appointing a seasoned Chief Commercial Officer to lead the function end-to-end; streamlining the organizational structure and strengthening commercial capabilities; and strategically expanding the team in line with priority areas and product launch timelines. The company has also set clear five-year business targets, including accelerating growth for existing products, preparing for the commercial rollout of Hexvix® and APL-1702, introducing new products within core therapeutic areas, maximizing synergies across the pipeline, and driving sales efficiency to the next level. Accelerating product launches to build momentum for sales In women's health, APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), is making steady progress toward market approval. In May 2024, the product's marketing application was officially accepted by the National Medical Products Administration (NMPA). As of the report's release, the Center for Drug Evaluation (CDE), NMPA had completed the first round of technical reviews, covering toxicology, clinical data, biostatistics, clinical pharmacology, and pharmaceutical quality. During the reporting period, the Inspection Center also wrapped up its Good Clinical Practice (GCP) inspection. The company has since received written feedback and is actively coordinating its responses to help expedite the review process and bring APL-1702 one step closer to approval. As a first-in-class treatment set to debut in China, APL-1702 is on track to become the world's first non-invasive therapy for HSIL — supported by robust clinical evidence and validated through an international Phase III trial. Experts note that, with China facing demographic pressures and a rising incidence of cervical intraepithelial neoplasia (CIN) among younger women, surgical excision of the cervix poses increasing challenges — especially during the critical period of fertility preservation. APL-1702 is expected to bridge this critical treatment gap and contribute to the creation of a more fertility-friendly healthcare landscape. To drive the commercialization of APL-1702, the company has hosted eight expert advisory meetings, focusing on Phase III clinical data, the current landscape of HSIL diagnosis and treatment, and unmet clinical needs. These sessions earned strong endorsement from leading gynecological and pharmaceutical experts, who recognized the innovation and clinical value APL-1702 brings to the table. The company has also made meaningful progress in building strategic partnerships with government agencies and leading academic associations. In collaboration with the Cancer Foundation of China, the company unveiled the first real-world showcase of its innovative cervical cancer prevention and control system at the 7th China International Import Expo (CIIE). It also signed medium- to long-term strategic cooperation agreements with both the China Women's Development Foundation and the Cancer Foundation of China during the event. The partnerships are set to roll out in 2025. The Women's Health Division has conducted extensive market and industry research, gaining deep insights into the needs of doctors and patients and broader commercial landscape. Based on this analysis, the team has finalized key launch strategies and mapped out a commercialization roadmap, laying the groundwork for a swift market rollout once approval is secured. Given the relative scarcity of innovation in the gynecological field, APL-1702 stands out as a meaningful breakthrough, backed by solid clinical evidence and proven efficacy. The company will continue to prioritize APL-1702 and its photodynamic drug-device combination platform, in a bid to build a comprehensive, tiered gynecological portfolio. This strategy will center on product iteration and indication expansion, while leveraging synergies across the pipeline to drive broader growth. In urological tumors, after the marketing application for Hexvix® was accepted in November 2023, the company's dynamic and highly skilled team sprang into action to support the review and approval process. As a result, Hexvix® received NMPA approval in November 2024, seven months ahead of the expected timeline. The product has since made history as the first diagnostic imaging agent approved in China for photodynamic blue light cystoscopy in bladder cancer detection. The Oncology Business Unit is fine-tuning the launch strategy for Hexvix®, initially targeting patients with commercial insurance or those willing to pay out-of-pocket. The early rollout will cover the special and international medical departments of top-tier hospitals in major cities, as well as premium foreign-invested and private urology specialty hospitals. As clinical guidelines are released and endorsements from leading urology experts are established, the launch will be paired with the introduction of disposable blue light cystoscopes. Together, these efforts aim to accelerate the adoption of blue light cystoscopy in general hospitals and foster an integrated approach to the diagnosis and treatment of bladder cancer. Focusing on strategic expansion in key areas and fast-tracking high-impact R&D initiatives Aligned with its strategic vision, Asieris has made significant strides in clinical development in 2024, with its global clinical initiatives progressing efficiently. In the fields of women's health, breast cancer, and gynecological tumors, Asieris has made remarkable progress. Building on the strong results of the international multicenter Phase III study of APL-1702, the company received feedback from its communication meeting with the U.S. FDA in December 2024, culminating in an agreement on a new Phase III clinical design to support the U.S. launch of APL-1702. Asieris is now actively seeking international partners to advance the U.S. Phase III clinical trial application. Additionally, APL-1702 is also being investigated for its potential in HPV virus clearance. Meanwhile, the U.S. FDA and China's NMPA approved the Phase I/IIa clinical trial applications for APL-2302 (a USP1 small molecule inhibitor) in advanced solid tumors in October 2024 and January 2025, respectively, with the first patient enrolled in Phase Ia in March 2025. Progress on APL-2501 (CLDN6/9 ADC) is also on track, with its preclinical research and unique linker platform selected for a poster presentation at the 2025 American Association for Cancer Research Annual Meeting (AACR 2025). In the field of urologic oncology, the Phase II clinical trial of oral APL-1202 in combination with tislelizumab as a neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) was successfully completed in September 2024, delivering encouraging efficacy signals. Among protocol-eligible patients, the pathological complete response (pCR) rates were 41% for the combination arm versus 20% for monotherapy. The combination was particularly effective in patients with low PD-L1 expression, where it achieved a pCR rate of 42% compared to just 11% with monotherapy. Meanwhile, APL-2401 — a dual FGFR2/3 small molecule inhibitor — has entered IND-enabling studies, with its findings selected for a poster presentation at AACR 2025. In addition, the investigational new drug (IND) application for APL-1202 in the treatment of free-living amoebae (FLA) infections was approved by the NMPA in June 2024. In January 2025, the company signed an investigational drug supply agreement under the Expanded Access IND Program with the Centers for Disease Control and Prevention (CDC) in the United States for APL-1202, subject to evaluation by CDC experts, to be used for treating FLA infections. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "2024 marks our first full year of commercialization. We delivered strong growth across our marketed products and reached a milestone by breaking even in our commercial operations. Our pipeline is entering a critical sprint toward market launch and is set to power the next wave of performance growth. While reinforcing our commercial capabilities, we're also accelerating clinical programs with a strategic focus on women's health and urological oncology. We're building a robust pipeline of first-in-class and highly-differentiated fast-follow therapies, while actively expanding into global markets to unlock the full value of our assets. With relentless innovation and execution, we are confident that Asieris will continue to make a meaningful difference for patients, deliver solid returns to shareholders, and create lasting value for society." Note: As of the date of this publication, APL-1702 has not been approved for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL). This article is intended to disclose the latest development of these products, not to serve as a promotional advertisement for the products. The relevant information is not intended for patients but is provided solely for the reference of healthcare professionals. If you like to learn more about these diseases, please consult healthcare professionals. SOURCE Asieris WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Phase 1

24 Mar 2025

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Clinical data presentations at the European Association of Urology (EAU) 2025 congress highlight the benefits of using Blue Light Cystoscopy in bladder cancer

OSLO, Norway, March 24, 2025 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces two abstract presentations at the 2025 European Association of Urology congress (EAU) in Madrid, Spain, highlighting the benefits of Blue Light Cystoscopy (BLC®), notably its impact on recurrence risk and ability to help urologists make the best bladder cancer management choices for their patients. The EAU annual meeting is one of the largest international meetings in the urology calendar, showcasing the latest and most relevant clinical and scientific advancements in this area of patient care. This year's event was held on March 21-24, 2025, and attracted urologists from all over the world. Photocure participated with its Hexvix® product designed for better detection and resection of bladder tumors under the theme that "Seeing is believing". As in the past two years, Photocure will make 2025 EAU bladder cancer session highlights available to healthcare professionals after the event, by means of video interviews with the presenters of these sessions at the Photocure booth B28. This successful initiative is once again supported by two of the leading names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy. In addition to this educational activity, the EAU scientific program prominently features Photocure's Hexvix product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable abstract presentations were: The impact of PDD on recurrence and progression in BCG-treated NMIBC* patients: a nationwide follow-up study (Abstract session 39: Sunday, March 23rd, 5:15pm CET – NMIBC: Advances in diagnosis and follow-up) This nationwide cohort study investigates the association of PDD on recurrence and progression risk in BCG-treated NMIBC patients, using Danish registry data from 2009-2022 assessing patients treated with BCG for primary NMIBC. In the study, 4318 patients from the Danish registry were identified with a first-time NMIBC diagnosis that were treated with BCG. Of the study subjects, 2388 (55%) of patients were diagnosed with the assistance of PDD. Basic demographics, stage and grade was comparable between the two groups. There were no differences in BCG-response across exposure groups. Age adjusted relative risk of recurrence was 0.88 (0.79 – 0.97) and 0.97 (0.89 – 1.05) at 1 and 5 years, respectively for the PDD-group compared to the non PDD-group. Age adjusted relative risk for progression was 0.93 (0.73 – 1.19) and 1.01 (0.84 – 1.21) at 1 and 5 years, respectively for the PDD-group. The authors conclude that, since the BCG-response across exposures were equal, the reduced risk of recurrence at 1 year was likely due to the detection effect of PDD: "The present study did not support the hypothesis of PDD modulating the BCG-response in NMIBC patients, suggesting a different mechanism for the impact of PDD on recurrence and progression in BCG-treated NMIBC patients." Read the abstract: Trans Urethral Laser Ablation of bladder tumors under local anesthesia: A prospective study of pain and recurrences (Abstract session 50: Monday, March 24th, 12:30pm CET – NMIBC: Innovations and outcomes 2) This study investigated the short- and long-term oncology safety regarding recurrence and progression as well as perioperative pain after office-based Transurethral Laser Ablation (TULA) or fulguration by PDD-assisted flexible cystoscopy. This prospective observational study enrolled eligible patients from August 2017 to June 2022 at Oslo University Hospital. 329 patients were enrolled, with a median age of 74 years. The median NRS (numeric rating scale) for perioperative pain was 4 (IQR: 3-5) for both the laser and fulguration group. The 12-month relapse-free survival (RFS) was 91% overall, 93% for fulguration, and 89% for laser ablation. The 12-month PFS was 94% for the laser group and 97% for the fulguration group. The authors conclude that office-based TULA under local anesthesia using PDD-assisted flexible cystoscopy is associated with low perioperative pain and does not compromise short- or long-term RFS or PFS. Therefore, it is a feasible option regarding perioperative pain and oncological safety. Read the abstract: "These new study data presented at EAU continue to emphasize the importance of using Blue Light Cystoscopy in the diagnostic pathway for bladder cancer. Minimally invasive procedures are on the rise and these abstracts also address data gaps in the long-term use of BLC in high-risk patients, where accurate staging determines all further treatment decisions", said Anders Neijber, Chief Medical Officer of Photocure. "BLC has been shown to clinically increase TURBT quality, more accurately stage disease, and enable better recurrence monitoring to help improve the lives of patients with bladder cancer." During the EAU Congress, on March 21, Photocure, in collaboration with Olympus, also hosted a well-attended scientific event on 'Precision Imaging in Bladder Cancer: Focus on Blue Light Cystoscopy'. The event, chaired by Ms. Bernadett Szabados (UCLH, London, UK) and Professor Christian Beisland (Haukeland University Hospital, Bergen, Norway), brought together leading experts who exchanged insights on the importance of advanced imaging technologies in urology. This collaboration between Photocure and Olympus underscores a shared commitment to innovation in cancer imaging and improving patient outcomes. *NMIBC: Non-muscle invasive bladder cancer **TURBT: trans-urethral resection of bladder tumors 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 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b 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: , accessed [February 2024]. 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. 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 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 CONTACT: 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] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

100 Deals associated with Hexaminolevulinate Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D04436	-	V04CX	DB06261

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	Italy	Photocure ASA	01 Mar 2005
Bladder Cancer	Czechia	Photocure ASA	01 Mar 2005
Bladder Cancer	France	Photocure ASA	01 Mar 2005
Bladder Cancer	Lithuania	Photocure ASA	01 Mar 2005
Bladder Cancer	Austria	Photocure ASA	01 Mar 2005
Bladder Cancer	Portugal	Photocure ASA	01 Mar 2005
Bladder Cancer	Greece	Photocure ASA	01 Mar 2005
Bladder Cancer	Germany	Photocure ASA	01 Mar 2005
Bladder Cancer	Spain	Photocure ASA	01 Mar 2005
Bladder Cancer	Belgium	Photocure ASA	01 Mar 2005
Bladder Cancer	Ireland	Photocure ASA	01 Mar 2005
Bladder Cancer	Denmark	Photocure ASA	01 Mar 2005
Bladder Cancer	Sweden	Photocure ASA	01 Mar 2005
Bladder Cancer	United Kingdom	Photocure ASA	01 Mar 2005
Bladder Cancer	Netherlands	Photocure ASA	01 Mar 2005
Bladder Cancer	Hungary	Photocure ASA	01 Mar 2005
Bladder Cancer	Norway	Photocure ASA	01 Mar 2005
Bladder Cancer	Estonia	Photocure ASA	01 Mar 2005
Bladder Cancer	Finland	Photocure ASA	01 Mar 2005
Bladder Cancer	Iceland	Photocure ASA	01 Mar 2005

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Cervical Intraepithelial Neoplasia	NDA/BLA	China	Asieris Pharmaceuticals Co., Ltd.	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	China	Asieris Pharmaceuticals Co., Ltd.	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	China	Trettiosjucorp AB	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	China	Asieris Meditech (Hong Kong) Co Ltd	11 May 2024
Bladder Cancer	NDA/BLA	China	Photocure ASA	29 Nov 2023
Bladder Cancer	NDA/BLA	China	Fresenius Kabi Austria GmbH	29 Nov 2023
Bladder Cancer	NDA/BLA	China	Patheon Italia SpA	29 Nov 2023
Non-Muscle Invasive Bladder Neoplasms	Preclinical	Netherlands	Photocure ASA	01 Jan 2005
Non-Muscle Invasive Bladder Neoplasms	Preclinical	Germany	Photocure ASA	01 Jan 2005
Non-Muscle Invasive Bladder Neoplasms	Preclinical	United States	Photocure ASA	01 Jan 2005

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04484415 (NEWS) Manual	Phase 3	Squamous Intraepithelial Lesions of the Cervix	-	APL-1702	(eidxrrhksr) = npzjhovxvg hxuxyiogmf (sgjyxbumss ) View more	Positive	12 Nov 2024
				Placebo	(eidxrrhksr) = jvdmhxfole hxuxyiogmf (sgjyxbumss ) View more
NCT05600322 (CTgov)	Phase 3	Bladder Cancer	158	Richard Wolf Photodynamic Diagnostic Equipment (PDD) system+Hexaminolevulinate Hydrochloride	aqkiinmupq(enlwcghhkc) = xgdomrbfwp bquexnquau (wimpgkwgmb, pffxgmsyty - uziiloidyf) View more	-	03 Oct 2024
Company_Website Manual	Phase 3	Squamous Intraepithelial Lesions of the Cervix	-	APL-1702 (Age ≥20 and <30)	hitwrnzkqa(ycdciyzpyf) = gtzjgegmcr izjnsvoecb (ppjhgtpnut ) View more	Positive	29 Sep 2024
				PBO (Age ≥20 and <30)	hitwrnzkqa(ycdciyzpyf) = stoucarizz izjnsvoecb (ppjhgtpnut ) View more
Company_Website Manual	Phase 3	Squamous Intraepithelial Lesions of the Cervix	-	APL-1702	(emewapfabj) = naekdunltw mmyhqvbdoj (tsfecwdspj ) View more	Positive	17 Sep 2024
				Placebo	(emewapfabj) = jsclhphwlm mmyhqvbdoj (tsfecwdspj ) View more
NCT04484415 (PRNewswire) Manual	Phase 3	Squamous Intraepithelial Lesions	402	Cevira (APL-1702)APL-1702)	(bwpolirstq) = mbyqzbjtnj qruvefmmly (zcwvwltnko ) View more	Positive	18 Mar 2024
				Placebo	(bwpolirstq) = ogqbaabfvv qruvefmmly (zcwvwltnko ) View more
NCT04484415 (APRICITY, Biospace) Manual	Phase 3	Squamous Intraepithelial Lesions	402	Cevira (APL-1702)	(twdfwlqpcm) = pcuokvbrbr eueojcozcg (zvugpkpdjb ) View more	Positive	18 Mar 2024
				Placebo	(twdfwlqpcm) = yukotpnfad eueojcozcg (zvugpkpdjb ) View more
NCT03058705 (CTgov)	Not Applicable	Bladder Cancer	10	Near Infrared Fluorescence (NIRF)+Hexaminolevulinate HCL	couzyyaoae(htrrswknlu) = jvloplyhuq plkdnmoajm (qalocizuot, ocoakhsfqo - rswykydiyi) View more	-	19 Aug 2019
MP43-06 (AUA2019)	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	208	Blue light cystoscopy with hexaminolevulinate	wfsonuqpag(bdzlxwixoi) = ixacrjexhz mryqisyzyv (wblofurgnm ) View more	-	01 Apr 2019
NCT02560584 (CTgov)	Phase 3	Bladder Cancer	304	KARL STORZ D-Light C PDD Flexible Videoscope System+Hexaminolevulinate hydrochloride	agjozvyiql(xjqfllwgdh) = kenlauvfid gfhwylaiol (unkaqrnnyy, qvebgrvexv - xbvcotvzjv) View more	-	02 Jul 2018
NCT02560584 \| NCT02660645 (Pubmed \| J Urol)	Phase 3	Bladder Cancer	304	Hexaminolevulinate (Blue light flexible cystoscopy)	whzexvdllk(esiykwdjzh) = nzsdxcapyg souacxvlzs (zuqngqksyx, 17.2 - 55.7) View more	-	01 May 2018
				Hexaminolevulinate (White light flexible cystoscopy)	wjagpevujc(ruhlsquvjw) = uyrmaenzjz wtwyqoncpf (lxvmjynghb )

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