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 Date01 Aug 2024

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT05962541 / Not yet recruitingPhase 4IIT

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 Jun 2024

Sponsor / Collaborator-

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

193

Literatures (Medical) associated with Hexaminolevulinate Hydrochloride

31 Dec 2023·Journal of Medical Economics

A cost-consequences and budget impact analysis of blue light-guided cystoscopy with Hexvix in patients diagnosed with non-muscle-invasive bladder cancer in France

Article

Author: Belsey, Jonathan

AIMSFrench guidelines for the management of non-muscle-invasive bladder cancer recommend that blue-light cystoscopy should be used in patients where the risk of missing residual tumor is highest. Despite evidence for its cost-effectiveness, budgetary concerns have limited uptake in France. The aim of this analysis was to model the cost-consequences of adopting the recommendations in a French urology unit.MATERIALS AND METHODSA budget impact model was developed in Excel, using a decision tree approach derived from guidelines issued by L'Academie franҫaise d'urologie. Risk profiles were derived from an analysis of studies using white-light cystoscopy; estimates for the impact of blue-light cystoscopy were derived from a published Cochrane Review. Costs were based on published tariff prices from L'Agence Technique de L'Information sur L'Hospitalisation. The model allowed results to be tailored to activity levels and projected blue-light usage in the chosen urology unit.RESULTSTwo scenarios were evaluated, based on a 3-year time horizon. Full implementation of all recommendations within a large public hospital was estimated to yield incremental costs of €269 per procedure (∼10% increase overall); a more targeted approach within a smaller private hospital yielded incremental costs of €133 per procedure (5% increase overall).LIMITATIONSThe basis of the model is a change in the time to first recurrence. There are no data available for subsequent recurrences or progression, both of which could have an influence on expenditure. Secondly, recurrence rates for blue-light cystoscopy were not specifically available for each patient group identified in the guidelines: extrapolation of data may have resulted in bias. Finally, the data were derived from clinical trials, which may not be generalisable to real-world clinical practice.CONCLUSIONSThe model has shown that the additional expenditure required to implement blue-light cystoscopy is modest and not disproportionate to the overall cost of care.

01 Dec 2023·European Urology Open Science

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

Article

Author: Elbæk, Sara Kaczor ; Dyrskjøt, Lars ; Taber, Ann ; Young-Halvorsen, Kristine ; Andreasen, Tine Ginnerup ; Jensen, Jørgen Bjerggaard ; Neijber, Anders

BackgroundTransurethral resection of bladder tumor (TURBT) is a central component in the diagnosis of non-muscle-invasive bladder cancer (NMIBC) and can be guided by several optical imaging techniques for better visualization of lesions.ObjectiveTo investigate if a change in tumor microenvironment (TME) composition could be observed as an effect of hexaminolevulinate (HAL)-assisted blue light cystoscopy (BLC) in TURBT samples from patients with bladder cancer.Design setting and participantsThis was a retrospective study of 40 patients with bladder cancer who underwent either BLC-guided TURBT (n = 20) or white light cystoscopy (WLC)-guided TURBT (n = 20) before radical cystectomy (RC). Tissue samples (n = 80) were collected from paired TURBT and RC specimens for all 40 patients. Tumor tissue was stained using multiplex immunofluorescence and immunohistochemistry.Outcome measurements and statistical analysisImmune cell infiltration was assessed according to the proportions of each immune cell or immune evasion marker and the relative change from TURBT as baseline was calculated. Statistical comparisons between groups were performed using the Wilcoxon rank-sum test or the paired-sample Wilcoxon test.Results and limitationsComparison of relative changes in the TME revealed a significant decrease in stromal infiltration of cytotoxic T cells (p = 0.024), B cells (p = 0.041), and stromal cells expressing PD-1 (p = 0.011) in patients treated with BLC-guided TURBT compared to WLC-guided TURBT.ConclusionsOur pilot study showed that HAL-BLC during TURBT in bladder cancer may influence the immune cell composition and TME.Patient summaryWe investigated the potential therapeutic effect of blue light versus white light for guidance in removing bladder tumors via the urethra in patients with bladder cancer. For blue light guidance, a compound called hexaminolevulinate is used to visualize tumor tissue. We found changes in immune cell composition that may have been influenced by the blue light guidance.

01 Sep 2023·BJUI compass

Blue light transurethral resection and biopsy of bladder cancer with hexaminolevulinate: Histopathological characteristics and recurrence rates in a single UK centre study.

Article

Author: Chan, Kimberley ; Vasdev, Nikhil ; Hayes, John ; Rabinowitz, Joshua ; Hampson, Alexander

IntroductionBlue light cystoscopy with hexaminolevulinate (HAL) during transurethral resection of bladder cancer (TURBT) has been shown to improve detection, thereby reducing bladder cancer recurrence compared with white light cystoscopy.MethodsSingle-centred UK (United Kingdom) study on 101 patients who underwent blue light cystoscopy between July 2017 and November 2020, performed by a single surgeon. Our study was divided into two arms; the primary arm had no prior diagnosis of bladder malignancy (N = 41), whereas secondary re-resection arm had (N = 57). Three patients with non-urothelial bladder cancer were excluded. Patients were followed up for 24 months. Data were collected on biopsy quality, histopathological characteristics and recurrence. The end points of the study were recurrence rate at 24 months in both arms and detection of CIS in patients who undergo TURBT or biopsy after initial white light study in the secondary, re-resection arm. This was analysed with Fisher's exact test.ResultsOf 98 patients, 39 had malignancy in their first blue light TURBT/biopsy: primary arm (10/41, 24.4%) and secondary arm (29/57, 50.9%), with detrusor present in 80.5% and 80.7%, respectively. In the secondary arm, blue light re-resection TURBT detected significantly more CIS (20.7% vs 51.7%, p = 0.0277) compared with white light with 3.4% upstaged to muscle invasive bladder cancer (G3pT2). Median time to re-resection was 3.06 months. Recurrence rate was 33.3% in the primary arm and 37.5% in the secondary arm after 24 months of follow-up.ConclusionOur data confirm that blue light TURBT with HAL provides superior detection and diagnosis of CIS in patients with previous white light cystoscopy.

News (Medical) associated with Hexaminolevulinate Hydrochloride

28 Aug 2024

·www.prnewswire.com

Asieris Pharmaceuticals Releases 2024 Semi-Annual Report, Highlighting Steady Progress in Launching Blockbuster Product for Precancerous Cervical Lesions and Continued Strengthening of Commercial Revenue Generation Capabilities

As of the date of this publication, APL-1702 has not been approved for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL); APL-1706 has not been approved for the diagnosis or surgical treatment of bladder cancer in China. 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. SHANGHAI, Aug. 28, 2024 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2024 Semi-Annual Report, showcasing a strong growth momentum. The launch of its blockbuster product APL-1702 is progressing smoothly, while the Commercial Team continues to enhance revenue-generating capabilities. The company's pipeline is advancing and broadening, currently with 13 major products and 18 ongoing research projects. As of the end of this reporting period, Asieris had approximately RMB 2.024 billion in cash, cash equivalents, and financial assets held for trading, ensuring ample capital for the company's continued growth and expansion. Advancing Launch of APL-1702 to Meet Strong Demand for Non-Invasive Treatment of Precancerous Cervical Lesions The new drug application for APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly. APL-1702 is a groundbreaking product that combines innovative, clinical, and social value. As a first-in-class treatment to be debuted in China, backed by proven efficacy in an international phase III trial, it is poised to become the world's first non-invasive therapy for HSIL. Clinically, APL-1702 is set to redefine the treatment paradigm of precancerous cervical lesions, moving beyond the one-size-fits-all approach of cervical resection. It aims to reverse disease progression while preserving the cervix, avoiding damage from resection, and supporting long-term management and recurrence prevention. From a societal perspective, managing HSIL patient is a crucial step in the "early diagnosis and early treatment" of cervical cancer. APL-1702 combines the value of early cervical cancer intervention and the promotion of a fertility-friendly society, and it is expected to contribute to the success of the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030) and the Healthy China Initiative. To support the commercialization of APL-1702, the company formally established the Women's Health Business Unit in early 2024. This unit is responsible for the domestic commercialization of APL-1702 in the Chinese market and expanding the company's gynecological pipeline. Key members, including the BU head and teams for marketing, government affairs, and regional commercialization, have already come on board, all bringing extensive experience in gynecology and multinational pharmaceutical companies. In the first half of this year, the Women's Health Business Unit conducted thorough market and industry research, developed a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the product's rapid market availability following its approval. The company has also convened three expert consultation meetings focusing on key topics such as review and dissimilation of phase III clinical data of APL-1702, the current state of HSIL diagnosis and treatment, and clinical needs. The meetings garnered strong endorsements from the principal investigators and leading national gynecologists, highlighting the innovation and clinical value of APL-1702. With this expert backing, the Women's Health Business Unit is pursuing strategic partnerships with government departments and industry associations to advance cervical cancer control and help shape a long-term management framework for precancerous lesions. Preparations are well underway, and a cooperation agreement is expected to be signed and implemented in the second half of the year. Given the scarcity of innovative drugs in gynecology, APL-1702 stands out with its solid clinical evidence and proven efficacy. Moving forward, the company will leverage APL-1702 and its drug-device combination platform to build a robust gynecological portfolio through external partnerships, indication expansion, and proprietary second-generation products. Commercial Capabilities Continue to Strengthen: Operating Revenue Increased by 130.98% from Q1 to Q2 During this period, the company's commercial team's revenue-generating capabilities continued to strengthen. In the first half of 2024, the Oncology Business Unit optimized its marketing strategies and execution quality despite a shifting competitive landscape and policy environment. While effectively controlling sales expenses, the company generated operating revenue of RMB 80.4934 million yuan in the first half of 2024, with RMB 56.1739 million earned in the second quarter, a 130.98% increase from the previous quarter. Alongside strong commercialization performance, the Oncology Business Unit is actively preparing for the launch of new products. The new drug application for APL-1706, a diagnostic and management agent for bladder cancer, was accepted in November 2023. Currently, APL-1706 is the world's only imaging agent approved to assist bladder cancer diagnosis or surgery. It has passed inspection by the Center for Food and Drug Inspection (CFDI), with NMPA approval expected by the end of June 2025. The Oncology Business Unit is refining a launch plan for APL-1706, exploring opportunities beyond surgical applications, such as outpatient examinations and strategic partnerships. The aim is to broaden market reach and benefit more patients. The team is developing strategies for post-launch access, pricing, expert endorsement, clinical collaboration, and dealer networks. Additionally, the company will build on its strong brand positioning with a strategy that combines in-house research and in-licensing, will actively pursue external partnerships to further enhance its commercial competitiveness and strengthen its position in oncology. Commit to Innovation and Drive Pipeline Expansion and Development Worldwide Guided by its strategy, Asieris has made significant strides in multiple clinical development programs in the first half of the year, with a strong push for global presence. In the field of women's health, following the positive results of the international phase III trial for APL-1702 and recognizing the substantial unmet clinical needs, Asieris plans to submit a pre-submission to the European Medicines Agency (EMA) in the fourth quarter of 2024. It also aims to be in discussion with the US Food and Drug Administration (FDA) this year on the design of a pivotal clinical program for the North American market and will apply for a phase III trial in due course. The company has also begun development of the HPV clearance indication. In the field of genitourinary tumors, the interim analysis for the phase II trial of APL-1202 with tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer has been completed, thus moving to the next evaluation stage. Data read-out from the phase II trial is expected in September 2024. The company's preclinical pipeline includes APLD-2304, AT-014, AT-020, AT-017, AT-018, and AT-021, with active R&D efforts underway. Notably, APL-2302 has advanced to the IND-enabling phase and is expected to receive IND approval within 2024. Compared to major competitors, APL-2302 offers potential advantages such as superior pharmacokinetics, a lower onset dose, and an optimal safety profile, supporting higher safe doses in humans. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "We remain optimistic and confident about the future of Asieris. The launch of our two core products, APL-1702 and APL-1706, is on track and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products. We also saw strong growth in commercialization, reduced operational costs, and increased efficiency in the first half, showcasing our ability to meet strategic goals. Looking ahead, we will remain focused on genitourinary tumors and women's health, aiming to deliver even greater value to both society and our shareholders." SOURCE Asieris

Phase 3Drug ApprovalINDPhase 2

07 Aug 2024

·www.prnewswire.com

Photocure ASA: Results for the second quarter of 2024

OSLO, Norway, Aug. 7, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , The Bladder Cancer Company, today reported Hexvix ® /Cysview ® revenues of NOK 122.4 million in the second quarter of 2024 (Q2 2023: NOK 115.9 million) and EBITDA of NOK 27.8 million (NOK 23.4 million). Photocure reiterates its 2024 financial guidance of product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses. Photocure now expects new and upgraded Saphira™ installations in the U.S. in the range of 55 to 70 towers for the full year, up from the previous range of 40 to 70 towers. "Photocure had a productive second quarter as we delivered Hexvix/Cysview revenue growth of 6% year-over-year and EBITDA of NOK 27.8 million. Year-to-date, we have reported 8% revenue growth, on track with our top-line guidance for the year. Once again, both our North American and European business segments had positive contributions during the period as we continue to grow revenues and contain our expenses. We also initiated key business development activities to accelerate our growth in the coming quarters and years," says Dan Schneider, President & Chief Executive Officer of Photocure. Photocure reported total group revenues of NOK 145.4 million in the second quarter of 2024 (NOK 144.3 million), and EBITDA* of NOK 27.8 million (NOK 23.4 million), driven by revenue growth and a milestone payment from Asieris for the NDA acceptance of Cevira® in China. Hexvix/Cysview revenues were NOK 122.4 million in the quarter (Q2 2023: NOK 115.9 million). The EBIT was NOK 20.7 million (NOK 16.8 million) and the cash balance at the end of the period was NOK 267.0 million. "During the second quarter, 20 new Saphira towers were installed including 5 new account placements, 3 accounts that upgraded to Saphira, and 12 mobile BLC towers delivered to ForTec Medical. High-definition Saphira systems now represent approximately 46% of the installed base of rigid BLC towers in the U.S. In early June, we announced our mobile tower initiative in the U.S. market, aligned with an agreement between ForTec and Karl Storz to provide on-demand Saphira BLC equipment to ForTec's vast network of hospital customers. ForTec is in the process of rolling out the program nationally, and we look forward to working with them to expand access to BLC procedures in the U.S.," Schneider adds. At the end of the second quarter of 2024, the installed base of rigid BLC systems in the U.S. was 381, up 17% from the same period in 2023. This includes 18 mobile towers owned by ForTec Medical. In the U.S. 25 flexible BLC towers remain active. After the closing of the quarter, Photocure entered into an agreement with Richard Wolf to develop and globally commercialize a high-definition blue light flexible cystoscope. "Turning to potential drivers of our long-term growth, we were very pleased to announce our partnership with Richard Wolf to develop and commercialize a state of the art high-definition flexible blue light system. Richard Wolf is a premier manufacturer of endoscopy equipment, and our partnership is focused on ensuring that physicians and patients have reliable access to state-of-the-art, high quality BLC in the surveillance setting. Given the number of new non-muscle invasive bladder cancer therapeutics that have, or are expected to enter the market, we believe that BLC technology will be more important than ever to properly identify, stage and manage bladder cancer patients. As we head into the second half of this year, we remain focused on accelerating the growth of our Hexvix/Cysview franchise, leveraging our established commercial infrastructure, and executing on the many initiatives and activities that can take Photocure to the next level," Schneider concludes. Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix®/Cysview® offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. The Company reiterates its 2024 financial guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses. Photocure now expects new and upgraded Saphira™ installations in the U.S. in the range of 55 to 70 towers, up from the previous range of 40 to 70 towers for the full year. Please find the full financial report and presentation enclosed. EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the second quarter 2024 financial report on page 25. The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at . Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST. The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through The presentation is scheduled to conclude at 14:45 CEST. For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl Chief Financial Officer Tel: +47 450 55 000 Email: [email protected] David Moskowitz Vice President of Investor Relations Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] 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 , All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This stock exchange announcement was published by Tolv Hillestad, Group Controller, Photocure ASA, on 7 August 2024 at 08:00 CEST. This information was brought to you by Cision The following files are available for download:

Financial Statement

15 Jul 2024

·www.prnewswire.com

Photocure and Richard Wolf Enter into Agreement to Develop a High-Definition Flexible Blue Light Cystoscope for Global Commercialization

OSLO, Norway, July 15, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, today announces that it has entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation 4K LED high-definition (HD) reusable flexible blue light cystoscope based on Richard Wolf's System blue technology. The partnership between Photocure and Richard Wolf is focused on developing technologically advanced flexible blue light cystoscopy (BLC ® ) equipment for the global market so that physicians who treat patients with bladder cancer can offer the benefits of BLC with Hexvix ® / Cysview ® in an outpatient, or surveillance setting. Under the Agreement, Richard Wolf will develop the new flexible BLC system with input and guidance from Photocure, tapping into Photocure's extensive knowledge of the surveillance procedure and the Company's experience with urology customers. The new flexible blue light system and underlying intellectual property will be owned by Richard Wolf, who will also serve as the sponsor of market authorizations around the world. Photocure and Richard Wolf will share expenses for the development and regulatory activities necessary for approvals of the HD flexible blue light system in markets where it will be commercialized. The strategic partnership between Photocure and Richard Wolf builds off a longstanding relationship between the two companies associated with co-promotion, disease awareness, education, market development, and clinical research. Photocure and Richard Wolf will co-promote the new blue light flexible system in the U.S., Europe and other countries globally. Photocure will leverage its existing sales organization to promote the new reusable flex system in North America and Europe, and will rely on Richard Wolf distributors or commercial partners to co-promote the device in other markets. Additionally, Photocure will utilize data from existing patient registries to leverage real-world evidence to further support the benefits of flexible blue light cystoscopy for patients with non-muscle invasive bladder cancer. Per the agreement, Photocure and Richard Wolf will establish two governance committees to oversee progress of the collaboration including a Joint Development Committee to ensure R&D milestones are successfully achieved and a Joint Commercialization Committee to execute pre- and post-approval go-to-market strategies globally. New flexible BLC equipment has not been available for purchase since early 2023 in the U.S., as prior systems were outdated and discontinued by the manufacturer. As a leading company focused on the management of bladder cancer, Photocure is dedicated to ensuring that BLC with Hexvix/Cysview is available to physicians worldwide in both the surgical and surveillance settings so that patients with bladder cancer can have access to the best care. "Entering into this partnership with Richard Wolf is a milestone for Photocure, and more importantly is the first step toward making high-definition BLC equipment in the surveillance setting consistently available for patients globally," said Dan Schneider, President and CEO of Photocure. "Before the phase-down of standard-definition flexible blue light equipment in the U.S., adoption of these systems was on a strong growth path with physicians recognizing the significant benefits of precision monitoring of bladder tumors with BLC and Cysview. We look forward to working with Richard Wolf on the development and anticipated commercialization of a 4K high-definition blue light cystoscope, and bringing a cutting edge and cost-effective solution to physicians and patients in our commercial territories as soon as possible." "As a full-service provider in endoscopy and a leading manufacturer of blue light cystoscopy equipment, we are very pleased to enter into this Agreement with Photocure, to develop and commercialize a first-in-class/best-in-class high-definition flexible blue light system," said Florian Happe, Vice President R&D at Richard Wolf. "The workmanship that goes into every Richard Wolf device provides the foundation for exceptional precision and longevity in the clinical setting, enabling our institutional and physician customers to deliver excellence in care to their patients. Surveillance of patients with bladder cancer is of critical importance in disease management, and we believe that a high-definition blue light cystoscope designed for out-patient use has potential to set a new standard in this care setting." 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 , , About Richard Wolf Richard Wolf GmbH is a medium-sized medical technology company with over 1,800 employees, along with eighteen subsidiaries and 130 foreign agencies worldwide. The company develops, produces, and distributes numerous products for endoscopy and extracorporeal shock wave treatment in human medicine. Integrated operating room systems round out the product range. 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] This information was brought to you by Cision . The following files are available for download: SOURCE Photocure

License out/in

100 Deals associated with Hexaminolevulinate Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04436	-	V04CX	DB06261

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Carcinoma in Situ	US	Photocure ASA	15 Feb 2018
Bladder Cancer	CH	Ipsen SA	06 Nov 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	CN	Trettiosjucorp AB	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	CN	Asieris Pharmaceuticals Co., Ltd.	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	CN	Asieris Meditech (Hong Kong) Co Ltd	11 May 2024
Bladder Cancer	NDA/BLA	CN	Asieris Pharmaceuticals Co., Ltd.	29 Nov 2023
Bladder Cancer	NDA/BLA	CN	Photocure ASA	29 Nov 2023
Bladder Cancer	NDA/BLA	CN	Patheon Italia SpA	29 Nov 2023
Bladder Cancer	NDA/BLA	CN	Fresenius Kabi Austria GmbH	29 Nov 2023
Genital Diseases	Phase 3	NO	Photocure ASA	01 Aug 2011
Genital Diseases, Female	Phase 3	NO	Photocure ASA	01 Aug 2011
Non-Muscle Invasive Bladder Neoplasms	Phase 3	DK	Photocure ASA	01 Apr 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04484415 (APRICITY, Biospace) Manual	Phase 3	Squamous Intraepithelial Lesions	402	Cevira (APL-1702)	(efumittzbi) = tpqbbkkwfm kgktfhkjcv (kdtnulzfwv ) View more	Positive	18 Mar 2024
				Placebo	(efumittzbi) = iqiweytefl kgktfhkjcv (kdtnulzfwv ) View more
PRNewswire Manual	Phase 3	Squamous Intraepithelial Lesions	402	Cevira (APL-1702)	(pybyuhkkkm) = gmcpwmpdin wprzbtpnwa (lrlaslhhpz ) View more	Positive	18 Mar 2024
				Placebo	(pybyuhkkkm) = yjqsimhqay wprzbtpnwa (lrlaslhhpz ) View more
NCT03058705 (CTgov)	Not Applicable	Bladder Cancer	10	Near Infrared Fluorescence (NIRF)+Hexaminolevulinate HCL	rtwzodqlhn(eyycmyctgc) = yylyotpeai hhkvhuwacp (djezkttzhm, svqmzjreoz - hxkwyyecrz) View more	-	19 Aug 2019
MP43-06 (AUA2019)	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	208	Blue light cystoscopy with hexaminolevulinate	qzmbuecqml(ktmknkhyar) = cgncmtzsyx oapnobdksu (ebqvdtfgaj ) View more	-	01 Apr 2019
NCT02560584 (CTgov)	Phase 3	Bladder Cancer	304	KARL STORZ D-Light C PDD Flexible Videoscope System+Hexaminolevulinate hydrochloride	gzojhooizv(opxjoqrsdm) = otibraqzhj tooygzqvrr (cthprdedvk, vvqowntlnx - pckqndepwt) View more	-	02 Jul 2018
NCT02560584 \| NCT02660645 (Pubmed \| J Urol)	Phase 3	Bladder Cancer	304	Hexaminolevulinate (Blue light flexible cystoscopy)	pbyzqpwrhb(fbmtfnkhdk) = okedqvkbmd jgqdvxhyqm (ajdculudxo, 17.2 - 55.7) View more	-	01 May 2018
				Hexaminolevulinate (White light flexible cystoscopy)	dbzytsayxl(dgixljkwxo) = uqjuwbrpwh icqyakmmqf (skdxbuvznz )
NCT02149342 (CTgov)	Phase 1/2	Actinic Keratosis	14	Hexylaminolaevulinate Cream (Hexylaminolaevulinate Cream)	becdorecmn(ipgobbxpfs) = otbmunqhsf itjtmtitst (uapaogddez, twpxfivlwh - jmyjnyporf) View more	-	11 Jul 2016
				Methylaminolaevulinate Cream (Methylaminolaevulinate Cream)	becdorecmn(ipgobbxpfs) = lvcehqdmvr itjtmtitst (uapaogddez, txmisxqpdt - kvnasjljnr) View more
NCT01256424 (Pubmed \| Am J Obstet Gynecol) Manual	Phase 2	Cervical Intraepithelial Neoplasia	262	hexaminolevulinate	(zbxawlpmnh) = xradgpynbm ekbeaggqnq (bqwhqjiyje ) View more	Positive	01 Apr 2015
				Placebo	(zbxawlpmnh) = bdkbvqtagj ekbeaggqnq (bqwhqjiyje ) View more
NCT01256424 (CTgov)	Phase 2	Cervical Intraepithelial Neoplasia	262	HAL 5% (HAL 5% With Illumination)	kxrrwmieza(qkensmiswb) = krliexkxnm syhrgfuauo (genxcwwmjw, kpnyhojeyv - qaqnnrpwbk) View more	-	21 Aug 2014
				illumination (HAL 1% With Illumination)	kxrrwmieza(qkensmiswb) = diborwqeye syhrgfuauo (genxcwwmjw, fbuntqhcxn - ypawwisczx) View more
NCT00412971 (CTgov)	Phase 3	Non-Muscle Invasive Bladder Neoplasms	233	Hexvix (Hexvix Cystoscopy Group)	dolcwqrfjt(omssdkvscf) = kdqzzraepy ieupgqpgzn (zfxqclacnn, hbvbbwxkdw - jbzqqhpdly) View more	-	11 Oct 2013
				Standard white light cystoscopy (White Light)	dolcwqrfjt(omssdkvscf) = rmbdesgknr ieupgqpgzn (zfxqclacnn, vquuxhevcn - cisuisiyjg) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis