This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are already considered standard of care in the treatment of muscle invasive bladder cancer. This trial attempts to determine whether the addition of nadofaragene firadenovec to the current standard regiment is safe and can improve oncological outcomes for those with muscle invasive bladder cancer.
Nadofaragene firadenovec, a type of intravesical gene therapy, is a weakened adenovirus that carries a copy of the gene for interferon alfa-2b. This medication gets absorbed by the bladder and stimulates the bladder to naturally create interferon alfa-2b, which is thought to kill bladder cancer. Nadofaragene firadenovec is given in a solution that is placed directly into the bladder (intravesical) using a thin tube called a catheter. It is a medication that is already FDA approved for the treatment of non-muscle invasive bladder cancer. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.

开始日期2026-09-01

申办/合作机构

University of Washington

[+1]

NCT06668493

/ Recruiting临床1/2期

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects With Low-grade Upper Tract Urothelial Carcinoma (LG-UTUC)

The primary purpose of this trial is to evaluate the safety & tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.

开始日期2025-06-12

申办/合作机构

Ferring Pharmaceuticals SA

NCT06929286

/ Recruiting临床3期IIT

COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial

The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).

开始日期2025-04-11

申办/合作机构

Memorial Sloan Kettering Cancer Center

100 项与 Nadofaragene firadenovec-vncg 相关的临床结果

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100 项与 Nadofaragene firadenovec-vncg 相关的转化医学

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100 项与 Nadofaragene firadenovec-vncg 相关的专利（医药）

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项与 Nadofaragene firadenovec-vncg 相关的文献（医药）

2026-06-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Advances in intravesical therapy for non-muscle-invasive bladder cancer

Review

作者: Tang, Yanfeng ; Zeng, Hao ; Zhu, Qiyu ; Xu, Chenhao ; Chen, Junru ; Liu, Haoyang ; Wang, Ling

Non-muscle-invasive bladder cancer (NMIBC) accounts for roughly 75% of newly diagnosed bladder cancer and associates with high risk of recurrence and progression. Intravesical therapy remains the cornerstone of NMIBC management following transurethral resection of bladder tumor (TURBT). For low-risk NMIBC, immediate single instillation of chemotherapy after TURBT effectively reduces recurrence. Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise. For high/very high-risk NMIBC, full-dose, 3-year BCG instillation remains the standard of care, However, global BCG shortages and treatment failures have prompted the need for alternative strategies. Optimization of BCG regimens, such as two induction courses, may preserve efficacy while improving feasibility. Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients. For those with BCG failure, a number of novel therapies are under active investigation. Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy.

2026-01-01·Advances in Cancer Research

Non-replicating adenoviral vectors for cancer gene therapy

Review

作者: de Oliveira, Soraia Barbosa ; Dos Santos da Luz, Jean Carlos ; Rodrigues, Otavio Augusto ; Alves, Ana Laura Vieira ; Strauss, Bryan E ; Barbosa, Mariana ; Niitsuma, Bianca Naomi ; Antunes, Fernanda

While there are many choices among gene transfer vectors for basic or applied research, non-replicating adenoviruses are among the most studied. The virus is well suited for in vivo gene therapy since the vector can be produced with relatively high titers, is an efficient platform for in vivo modification of a variety of target cells and is relatively safe considering that the viral genome remains episomal. The production of adenoviral vectors is scalable and, once virus particles have been recovered, does not depend on the transfection of plasmids, a costly and laborious process to perform on large scale and with pharmaceutical quality. These vectors can be extensively modified to provide targeting at the level of transduction and transgene expression. The use of a non-replicating vector implies that it will not express viral proteins but instead can be modified to carry coding or non-coding sequences, including those that may be prejudicial to the life cycle of replicating viruses. Admittedly, immunogenicity of adenoviral vectors is an issue that requires careful consideration but may be leveraged to act as an adjuvant for vaccines or to overcome the immunosuppressive tumor microenvironment. Modifications also allow adenoviral vectors to act as important allies for achieving long-term expression. If viral replication is desired, non-replicating vectors can be paired with conditionally replicating adenovirus, thus providing the best of both approaches. To date, three cancer gene therapy products, Gendicine, Adstiladrin, and Papzimeos, that are based on non-replicating adenovirus have been approved for commercialization. As we will explore here, non-replicating adenoviral vectors continue to be developed for cancer gene therapy.

2026-01-01·Gan to kagaku ryoho. Cancer & chemotherapy

[Evolving Pharmacotherapy for Bladder Cancer-From Non-Muscle-Invasive to Metastatic Disease-Development of Novel Therapies for BCG-Unresponsive NMIBC].

Review

作者: Inoue, Keiji ; Shigehisa, Ryu ; Fukata, Satoshi

Bladder cancer is a common malignancy in the elderly, with approximately 75% of cases diagnosed as non-muscle-invasive bladder cancer(NMIBC).Although transurethral resection of bladder tumor(TURBT)is the standard initial treatment, recurrence rates remain high, and intravesical Bacillus Calmette-Guérin(BCG)instillation has long been used as an adjuvant therapy.However, about 30% of patients develop BCG-unresponsive disease despite adequate BCG administration.Radical cystectomy is recommended in such cases, but its invasiveness and impact on quality of life(QOL)often make it impractical in real-world settings.Thus, the development of novel bladder-preserving treatments is urgently needed.In recent years, diverse approaches including immune checkpoint inhibitors(ICI), gene therapy, drug delivery systems(DDS), and oncolytic virus-based therapies have been actively investigated, with numerous clinical trials ongoing worldwide.Importantly, pembrolizumab, nadofaragene firadenovec, and N-803 in combination with BCG have received FDA approval, representing major advances in the management of BCG-unresponsive NMIBC.In addition, promising agents such as TAR-200, cretostimogene grenadenorepvec, and detalimogene voraplasmid are under clinical evaluation.These advances indicate the potential for novel strategies that enable bladder preservation while achieving tumor control.Future challenges include validation of long-term outcomes, establishment of evidence through randomized controlled trials, and regulatory approval and reimbursement in Japan.Expansion of therapeutic options is expected to improve both prognosis and QOL in this high-risk population.

135

项与 Nadofaragene firadenovec-vncg 相关的新闻（医药）

2026-06-30

·今日头条

溶瘤治疗：让病毒和细菌变成抗癌工具

溶瘤治疗：让病毒和细菌变成抗癌工具，这条路到底怎么走？很多人第一次听到“溶瘤病毒”或“溶瘤菌”，第一反应大概是：病毒、细菌不是会让人生病吗？怎么还能拿来治癌？这个问题问得很对。溶瘤治疗的核心，不是把普通病毒、普通细菌直接打进人体，而是利用它们某些天然特性，再经过筛选、减毒或基因工程改造，让它们更偏向肿瘤环境，并把肿瘤从“免疫系统看不清的地方”，变成“免疫系统必须处理的现场”。如果用一个不太严肃但好懂的比喻：传统化疗像是大范围轰炸；靶向药像是瞄准某个关键零件；PD-1 这类免疫治疗像是解除免疫刹车。而溶瘤治疗更像是把一个“引爆器”送进肿瘤内部：一方面直接破坏肿瘤细胞，另一方面把肿瘤里的抗原、炎症信号和免疫细胞都调动起来。它真正有意思的地方，不只是“把肿瘤细胞杀死”，而是把一次局部破坏，尽量变成一次全身抗肿瘤免疫动员。快读要点溶瘤治疗不是“病毒或细菌神奇吃掉癌症”，而是利用微生物的复制、定位和免疫刺激能力，改造肿瘤局部环境。溶瘤病毒更像进入肿瘤细胞内部的“复制型武器”；细菌路线更强调肿瘤定位、局部免疫激活和工程化递送。 T-VEC 是代表性溶瘤病毒产品；BCG 膀胱灌注则是细菌参与抗肿瘤免疫治疗最成熟的现实样板。已上市产品包括 Imlygic/T-VEC、Oncorine/H101、Delytact/G47Δ，以及膀胱癌场景中的 TICE BCG。这条路线未来更可能作为“肿瘤免疫点火器”，与免疫检查点抑制剂、放疗、化疗、细胞治疗等组合使用。一、溶瘤治疗不是一条路线，而是一组路线大体上，可以分成两类。第一类是溶瘤病毒。它们通常来自疱疹病毒、腺病毒、痘苗病毒、呼肠孤病毒、柯萨奇病毒等。经过改造后，病毒更容易在肿瘤细胞里复制，而在正常组织里复制能力受到限制。病毒进入肿瘤细胞后，会利用细胞资源复制自己，最后让肿瘤细胞裂解。细胞一裂，肿瘤抗原、病毒成分和危险信号就一起释放出来，免疫系统被迫注意到这个原本“装死”的肿瘤。第二类可以宽泛叫细菌疗法，或者更准确地说，肿瘤靶向细菌/细菌免疫治疗。有些细菌天然喜欢低氧、坏死、免疫抑制的肿瘤微环境；有些细菌可以被工程化，携带细胞因子、毒素片段或免疫调节分子。它们未必都像病毒那样直接把肿瘤细胞“撑爆”，更多时候是把肿瘤局部变成一个免疫炎症现场。所以，“溶瘤菌”这个词可以用于科普，但专业一点讲，它包含了细菌介导的肿瘤定位、局部免疫激活和工程化递送，并不都等同于直接裂解肿瘤。二、溶瘤病毒的代表案例：T-VEC 如果要找一个最适合普通读者理解的溶瘤病毒案例，T-VEC 是绕不开的。 T-VEC，全名 talimogene laherparepvec，商品名 Imlygic。它是基于 1 型单纯疱疹病毒，也就是 HSV-1 改造而来的溶瘤病毒，主要用于部分不可手术切除、可以直接注射病灶的黑色素瘤。 T-VEC溶瘤病毒机制图它的设计逻辑可以拆成三步。第一步，瘤内注射。 T-VEC 不是像普通输液那样全身给药，而是直接打进可见或可触及的肿瘤病灶里。这样做的好处是让病毒优先到达肿瘤现场，同时降低全身暴露。第二步，选择性复制并裂解肿瘤细胞。 T-VEC 删除了 HSV-1 中与正常细胞复制能力相关的关键基因，例如 ICP34.5。简单说，正常细胞遇到病毒会启动防御反应，而许多肿瘤细胞这套防御已经坏掉了，所以改造后的病毒更容易在肿瘤细胞里复制。病毒复制到一定程度，肿瘤细胞会裂解，释放出新的病毒颗粒和肿瘤抗原。第三步，激活免疫系统。 T-VEC 还加入了 GM-CSF 这个免疫刺激因子。它的作用可以理解为“喊人”：吸引并激活树突状细胞，让它们把肿瘤抗原呈递给 T 细胞。于是，治疗目标就不只是被注射的那个肿瘤结节，而是希望诱导更广泛的抗肿瘤免疫反应。所以，T-VEC 不是简单的“病毒吃肿瘤”。更准确地说，它是“局部病毒复制 + 肿瘤裂解 + 免疫激活”的组合方案。三、细菌路线的主流案例：BCG 膀胱灌注如果讲细菌治疗，最成熟、最有临床存在感的例子不是某个很新的工程菌，而是一个老朋友：BCG。 BCG 本来是卡介苗，也就是减毒牛型结核分枝杆菌。它最出名的身份是疫苗，但在肿瘤治疗里，它还有另一个重要身份：非肌层浸润性膀胱癌的膀胱灌注治疗。 FDA 对 TICE BCG 的产品信息中，明确列出其用于膀胱原位癌治疗和预防，以及经尿道切除术后 Ta/T1 乳头状肿瘤复发预防。 BCG膀胱灌注机制图 BCG 的逻辑和 T-VEC 不一样。它不是把细菌送进全身血液，也不是让细菌在全身“追杀肿瘤”。它是通过导尿管把 BCG 灌注到膀胱里，让它主要在膀胱局部发挥作用。第一步，膀胱灌注。医生将 BCG 悬液注入膀胱，让它接触膀胱黏膜和残留肿瘤细胞。这也是为什么 BCG 特别适合膀胱癌这个场景：膀胱是一个相对封闭、可以局部给药的器官。第二步，局部免疫被唤醒。 BCG 可以附着在膀胱上皮和肿瘤细胞附近，引发局部免疫反应。巨噬细胞、树突状细胞、中性粒细胞、NK 细胞和 T 细胞会被招募过来，细胞因子也会增加。用普通话讲，就是原本安静的膀胱局部，突然变成一个免疫系统高度警觉的地方。第三步，清除残留肿瘤细胞，降低复发风险。非肌层浸润性膀胱癌常常在手术切除后仍有复发风险。BCG 的价值，不是像手术刀一样切掉肿瘤，而是在术后通过局部免疫刺激，帮助清理残留风险，降低复发。所以，BCG 不是典型意义上“细菌直接溶解肿瘤”的方案。它更像是“用细菌训练和激活局部免疫系统”。但从治疗思想上看，它是细菌参与抗肿瘤治疗最成熟的现实样板。四、病毒路线和细菌路线有什么不同？这两条路线都在利用微生物，但思路不完全一样。溶瘤病毒：进入细胞内部的复制型武器。它的关键问题是：能不能选择性进入并复制？能不能裂解肿瘤？能不能激活后续免疫？能不能避开过强的抗病毒清除？细菌路线：利用肿瘤微环境和局部免疫反应。它的关键问题是：能不能安全地定植或停留在肿瘤区域？能不能激活合适强度的免疫？会不会造成感染风险？工程化改造后能不能稳定可控？如果把它们放进肿瘤免疫的大框架里，二者共同目标都是把肿瘤从“免疫系统不愿意进去的地方”，改造成“免疫系统愿意进去、看得见、打得动的地方”。五、现在市面上真正能看到哪些主流产品？讲溶瘤治疗，很容易一不小心讲成“未来概念”。但这条路不是完全停在实验室里，已经有一些产品进入了真实市场。 Imlygic，也就是 T-VEC。这是目前最具代表性的溶瘤病毒产品之一，由 Amgen 旗下 BioVex 开发，基于 HSV-1 改造。美国 FDA 页面列出的适应证，是用于黑色素瘤患者术后复发、不可切除的皮肤、皮下和淋巴结病灶的局部治疗。它的意义在于：证明“工程化溶瘤病毒 + 局部注射 + 免疫激活”可以成为获批药物。 Oncorine，也就是 H101。这是中国批准上市的溶瘤腺病毒产品，由上海三维生物开发，通常被认为是全球最早获批的溶瘤病毒药物之一。它基于 5 型腺病毒改造，主要用于头颈部肿瘤相关场景，常见讲法是与化疗联合使用。它的临床定位和国际影响力不如 T-VEC 那么大，但在“溶瘤病毒从概念走向产品”这件事上非常重要。 Delytact，也就是 teserpaturev / G47Δ。这是日本批准的溶瘤 HSV-1 产品，用于恶性胶质瘤相关治疗场景。它同样属于工程化疱疹病毒路线。和 T-VEC 相比，它面向的是脑肿瘤这样更复杂、更难递送的场景，因此更适合作为“溶瘤病毒进入高难度实体瘤”的案例来理解。 TICE BCG。这是现实中最成熟、最常被使用的细菌抗肿瘤免疫产品之一。FDA 页面列出的适应证包括膀胱原位癌的治疗和预防，以及 Ta/T1 乳头状肿瘤经尿道切除后的复发预防。它不是“细菌直接吃掉肿瘤”的药，而是通过膀胱局部灌注，激活局部免疫反应，从而降低复发风险。六、为什么溶瘤治疗常常要联合用药？因为肿瘤不是一团被动等待攻击的细胞。它有免疫抑制微环境，有异常血管，有物理屏障，有抗原异质性，也有不断进化的逃逸能力。单靠一个病毒或一种细菌，通常很难解决所有问题。所以现在更被看好的方向，是联合治疗。比如，溶瘤病毒先在肿瘤局部造成裂解和炎症，释放抗原，把“冷肿瘤”变成“热肿瘤”；然后再联合 PD-1/PD-L1 抑制剂，让被激活的 T 细胞不要被刹车按住。细菌路线也类似。工程菌可以被设计成携带免疫因子、局部释放药物，或者改变肿瘤微环境，再与免疫检查点抑制剂、放疗、化疗或细胞治疗配合。未来的重点，可能不是问“溶瘤治疗能不能单药治愈癌症”，而是问：它能不能成为肿瘤免疫治疗里的“点火器”。七、这条路线最难的地方在哪里？第一是安全性。病毒和细菌都不是普通小分子药物。它们会复制、会诱导免疫反应，也可能引发炎症、感染或不可预期的扩散。因此，减毒设计、复制控制、给药路径和患者筛选非常关键。第二是递送。肿瘤并不是一块均匀海绵。药物打进去以后，能不能扩散到足够多的区域？静脉给药时会不会被免疫系统迅速清除？这些都是现实问题。第三是疗效预测。哪些患者更适合？哪些肿瘤更容易从“冷”变“热”？哪些生物标志物能提示疗效？如果没有这些答案，临床开发就容易变成盲试。第四是生产和质控。活病毒、活细菌或工程菌不是普通化合物。批次一致性、遗传稳定性、污染控制、储存运输、给药操作，都会影响真实落地。八、怎么理解它的前景？溶瘤治疗不是万能钥匙，也不是肿瘤治疗里的边角料。它最有价值的位置，可能是连接“局部治疗”和“系统免疫”的桥梁。 T-VEC 说明，经过改造的病毒可以被做成真实药物，进入临床应用；BCG 说明，细菌激活局部抗肿瘤免疫这件事，并不是停留在概念里，而是已经在膀胱癌治疗中用了很多年。但它们也同时提醒我们：微生物疗法的成功高度依赖场景。能不能局部给药？肿瘤是否可接触？免疫系统是否还有反应能力？联合治疗怎么设计？这些都会决定最后效果。所以，对溶瘤治疗最稳妥的判断是：它不是用病毒或细菌“神奇吃掉癌症”，而是利用微生物的复制、定位和免疫刺激能力，把肿瘤现场改造成一个更容易被免疫系统识别和攻击的战场。真正的未来，不一定是单打独斗，而是和免疫检查点抑制剂、细胞治疗、放疗、化疗、肿瘤疫苗和工程化递送系统一起，成为组合疗法中的关键一环。主要参考来源 [1] FDA：TICE BCG 产品信息，列明 BCG Live 的适应证包括膀胱原位癌治疗/预防，以及 Ta/T1 乳头状肿瘤经尿道切除后的复发预防。https://www.fda.gov/vaccines-blood-biologics/vaccines/tice-bcg [2] FDA：IMLYGIC 产品信息，列明 talimogene laherparepvec 的商品名、生产企业和黑色素瘤局部治疗适应证。https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/imlygic [3] FDA：ADSTILADRIN 产品信息，列明 nadofaragene firadenovec-vncg 为用于 BCG 无应答高危非肌层浸润性膀胱癌的腺病毒载体基因治疗产品。https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin [4] FDA：ANKTIVA 批准信息，列明 nogapendekin alfa inbakicept-pmln 与 BCG 联合用于 BCG 无应答非肌层浸润性膀胱癌。https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer [5] Talimogene laherparepvec / T-VEC 公开药物资料：T-VEC 为 HSV-1 改造的溶瘤病毒，采用瘤内注射，用于部分不可手术黑色素瘤，并通过肿瘤裂解和 GM-CSF 介导的免疫激活发挥作用。https://en.wikipedia.org/wiki/Talimogene_laherparepvec [6] Oncorine / H101 与 Delytact / G47Δ 公开资料：用于梳理中国、日本已上市溶瘤病毒产品的基本定位和历史背景。https://en.wikipedia.org/wiki/Oncolytic_virus [7] OPTiM 研究与 T-VEC 相关综述资料：T-VEC 的临床开发和机制讨论主要围绕瘤内注射、肿瘤细胞裂解、GM-CSF 表达和系统性抗肿瘤免疫反应展开。免责声明本文用于科普和产业技术讨论，不构成医疗建议、投资建议或产品推荐。具体诊断、治疗选择和用药方案必须由专业医生根据患者病情、指南和获批适应证决定；文中涉及的药物、企业和研发进展，请以监管机构、企业公告、论文原文和临床试验登记信息为准。

2026-05-29

·theralase.com

Theralase® Provides an Update on its Phase II Bladder Cancer Clinical Study

TMX NewsfileMay 29, 2026 5:04 PM EDT Theralase® Provides an Update on its Phase II Bladder Cancer Clinical Study Toronto, Ontario–(Newsfile Corp. – May 29, 2026) – Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) (“Theralase®” or the “Company“), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancer, bacteria and viruses has released the Company’s unaudited interim consolidated financial statements for the three-month period ended March 31st, 2026 (“Financial Statements“). Theralase® will be hosting a conference call on June 9th at 11:00 am ET, which will include a presentation of the financial and operational results for the quarter ended March 31st, 2026. To ensure Theralase® has time to address questions during the call, please e-mail them in advance to mperraton@theralase.com. An archived version will be available on the website following the conference call. Table 1: Financial Summary for the Quarter Ended March 31st To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_001full.jpg Financial Highlights: For the Quarter ended March 31st, 2026 (All funds in Canadian Dollars): Total revenue increased to $132,634 from $91,190 for the same period in 2025, a 45% increase. Cost of sales for the three-month period ended March 31st, 2026, was $68,250 (51% of revenue) resulting in a gross margin of $64,382 (49% of revenue). In comparison, the cost of sales for the same period in 2025 was $77,896 (85% of revenue) resulting in a gross margin of $13,294 (15% of revenue). Selling expenses decreased to $66,534 from $68,143 for the same period in 2025, a 2% decrease. The decrease in selling expenses is primarily a result of decreased spending on advertising (64%) and travel (38%). Administrative expenses for three-month period ended March 31st, 2026, decreased to $463,553 from $555,074 for the same period in 2025, a 16% decrease. The decrease in administrative expenses is primarily a result of decreased spending on insurance (20%) and professional fees (45%). Net research and development expenses for the three-month period ended March 31st, 2026, decreased to $564,724 from $877,670 for the same period in 2025, a 36% decrease. The decrease in research and development expenses is attributed to a decrease in costs for Study II patient enrollment and treatment, as the clinical study reaches completion. Research and development expenses represented 52% of the Company’s operating expenses and represent investment into the research and development of the Company’s Drug Division. The net loss for the three-month period ended March 31st, 2026, was $1,031,785, which included $172,118 of net non-cash expenses (i.e.: amortization, stock-based compensation expense). This compared to a net loss for the same period in 2025 of $1,471,250, which included $254,523 of net non-cash expenses. The Drug Division represented $803,352 (78%) of this loss. The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II, as the clinical study reaches completion. Operational Highlights: Collaborative Clinical Development Agreement On January 12th, 2026, the Company announced that it had entered into a collaborative clinical development agreement dated January 9th, 2026 with Ferring Pharmaceuticals, expanding the Company’s existing Phase II NMIBC clinical program (NCT03945162) through the addition of a new cohort evaluating Ruvidar® (TLD-1433) in combination with Adstiladrin® (nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk Bacillus Calmette-Guérin (“BCG“)-Unresponsive Non-Muscle Invasive Bladder Cancer (“NMIBC“) Carcinoma In-Situ (“CIS“) with or without papillary disease (±Ta/T1) (“Study II“). Under the terms of the agreement, the Company will remain the sponsor of the study, with both parties providing clinical oversight through a joint development committee. The new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions. Study II Interim Clinical Data Cohort 1 Theralase® has completed enrollment in Study II, with the Clinical Study Sites (“CSSs“) enrolling and providing the primary Study Procedure to 92 patients. Additional patients may be enrolled, until all CSSs have been closed to enrollment. According to the clinical study design, a patient is considered to have completed Study II, if they received the Study Procedure and have been assessed by the Principal Investigator (“PI“) for up to 15 months or they have been prematurely removed from the clinical study by the PI for failure to respond or failure to comply with the clinical study design. According to this definition, 82 patients have completed Study II (with 10 patients on study pending clinical data), resulting in the following interim clinical data in support of the Study II endpoints: A total of 92 patients have been enrolled and treated in the study. Of these patients, 81% were ≥ 65 years of age, 81% male and 83% white. Tumour stage was distributed as follows: pure 81% CIS; 12% CIS + T1; and 7% CIS + Ta. 98% were classified as BCG-Unresponsive with 2% BCG-Intolerant. The median number of BCG instillations was 15.5. As of May 29th, 2026, 89 patients have been assessed for response outcomes, evaluable for the primary endpoint analysis. Primary Endpoint Performance (Complete Response at any Point in Time) The primary endpoint of Study II is the achievement of Complete Response (“CR“) at any point in time following administration of the Study Procedure. Interim analysis demonstrates that 65.2% (58 out of 89) evaluable patients achieved CR. Table 2: Primary Endpoint Performance Approximately, 2 out of 3 patients diagnosed with BCG-Unresponsive NMIBC CIS (with or without Ta/T1) achieved a CR following treatment with the Theralase® Study Procedure. Secondary Endpoint Performance (Duration of CR – 12 Months) The secondary endpoint evaluates the sustainability of CR at 12 months, after initial CR determination (450 days post-treatment). Among patients evaluable for durability of response, 40.4% (21 of 52 evaluable patients) maintained a CR at 450 days. Table 3: Secondary Endpoint Performance Tertiary Endpoint Performance (Safety) The tertiary endpoint is defined as patients who have a Serious Adverse Event (“SAE“) ≥ 4 directly caused by the Study Drug or Study Device, which did not resolve within 450 days. Theralase® and the independent Data Safety Monitoring Board believes all SAEs reported to date are unrelated or unlikely related to the Study Drug or Study Device. The tertiary endpoint assesses the safety profile of the Study Procedure. Treatment Emergent Adverse Events (“TEAEs“) were noted, but did not meet the SAE criteria. TEAEs included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%), which resolved within 1 month of treatment. There have been 24 SAEs reported: 1 x Grade I, 3 x Grade II, 13 x Grade III, 5 x Grade IV (all resolved between 1 to 82 days) and 2 x Grade V (Unlikely Related to the Study Drug, Study Device or Study Procedure). A high majority of SAEs were not treatment related and none were directly related to the Study Drug or Study Device. Table 4: Tertiary Endpoint Performance Duration of CR – Extended Time Points Patients who have completed the study were followed for up to 3 years after initial treatment at extended time points. Table 5: Duration of CR at Extended Time Points One patient demonstrated CR for 7 years, after one Study Procedure. On Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years is 48.6%, 34.5% and 25.4%, respectively. Figure 1: Kaplan-Meier Curve To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_003full.jpg Figure 2: Swimmer’s Plot To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_figure2.jpg Figure 3: Patient Population To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_007full.jpg Regulatory Pathway, Commercialization Strategy and FDA Guidance If approved by Health Canada and the FDA, the clinical data collected from Study II represents a transformative therapeutic option for patients diagnosed with BCG-Unresponsive NMIBC CIS, who would otherwise face radical cystectomy (surgical removal of the bladder). The Theralase® procedure has demonstrated a robust CR and sustained durability of that response, with the majority of patients receiving only a single procedure. Following the completion of patient follow-up and final clinical data analysis, Theralase® intends to submit a New Drug Application (“NDA“) to Health Canada and the United States Food and Drug Administration (“FDA“) in 3Q2026, under a rolling review, with regulatory decisions anticipated in 1H2027. Cohort 2 Theralase®, in conjunction with Ferring Pharmaceutical, subject to FDA approval, is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar® with Adstiladrin. It is anticipated that the complementary mechanisms of action (Ruvidar® targets bladder cancer cells directly, Adstiladrin® targets health bladder cells to produce Interferon to stimulate the innate and adaptive immune system) will provide a strong additive effect in the treatment of patients being treated for BCG-Unresponsive NMIBC CIS. In the procedure, patients will be treated with Ruvidar® (1 hour of drug instillation, approximately 1 hour of light activation), then at another visit, they will be treated with Adstiladrin® (1 hour procedure), both in outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of Adstiladrin®. The presiding uro-oncologist will have the option to deliver an additional re-induction Study Procedure, if the patient recurs. The patient will be followed for 15 months after initial Study Procedure and up to 3 years for post-study follow-up. Commercialization and Strategic Partnerships In parallel with the finalization of Study II, Theralase® is actively pursuing commercialization opportunities and strategic partnerships to support the global marketing and distribution of Ruvidar®. The Company is interested in engaging in discussions with pharmaceutical companies across multiple geographic regions regarding: Licensing arrangements for Ruvidar® in the treatment of BCG-Unresponsive NMIBC CIS in various geographic territories Collaborative clinical research initiatives focused on the application of light-activated Ruvidar® for broader NMIBC indications Collaborative clinical research combining Ruvidar®, with other FDA-approved drugs to enhance treatment efficacy About Study II:Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 92 BCG-Unresponsive NMIBC CIS patients in 11 clinical study sites located in Canada and the United States. About Theralase® Technologies Inc.:Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses. Additional information is available at www.theralase.com and www.sedarplus.ca Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward Looking StatementsThis news release contains Forward-Looking Statements (“FLS“) within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company’s proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words “may, “should“, “will“, “anticipates“, “believes“, “plans“, “expects“, “estimate“, “potential for” and similar expressions; including, statements related to the current expectations of the Company’s management regarding future research, development and commercialization of the Company’s small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; access to sufficient capital to fund the Company’s operations is available on terms that are commercially favorable to the Company or at all; the Company’s small molecule and formulations may not be effective against the diseases tested in its clinical studies; the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company’s ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company’s ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS. All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach out Investor Inquiries – Theralase Technologies. For More Information:1.866.THE.LASE (843.5273)416.699.LASE (5273)www.theralase.com Kristina Hachey, CPAChief Financial Officer X 224khachey@theralase.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/299492

临床2期财报临床结果引进/卖出临床1期

2026-05-29

·BioSpace

Theralase(R) Releases Q1 2026 Financial Statements

Theralase(R) Provides an Update on its Phase II Bladder Cancer Clinical Study Toronto, Ontario--(News - May 29, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) (" Theralase® " or the " Company "), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancer, bacteria and viruses has released the Company's unaudited interim consolidated financial statements for the three-month period ended March 31 st , 2026 (" Financial Statements "). Theralase® will be hosting a conference call on June 9 th at 11:00 am ET , which will include a presentation of the financial and operational results for the quarter ended March 31 st , 2026. To ensure Theralase® has time to address questions during the call, please e-mail them in advance to mperraton@theralase.com . Zoom Meeting Link: Conference Call in: 1-647-558-0588 (Canada) / 1-646-558-8656 (US) - not required for those attending by Zoom. An archived version will be available on the website following the conference call. Table 1: Financial Summary for the Quarter Ended March 31 st To view an enhanced version of this graphic, please visit: Financial Highlights: For the Quarter ended March 31 st , 2026 (All funds in Canadian Dollars): Total revenue increased to $132,634 from $91,190 for the same period in 2025, a 45% increase. Cost of sales for the three-month period ended March 31 st , 2026, was $68,250 (51% of revenue) resulting in a gross margin of $64,382 (49% of revenue). In comparison, the cost of sales for the same period in 2025 was $77,896 (85% of revenue) resulting in a gross margin of $13,294 (15% of revenue). Selling expenses decreased to $66,534 from $68,143 for the same period in 2025, a 2% decrease. The decrease in selling expenses is primarily a result of decreased spending on advertising (64%) and travel (38%). Administrative expenses for three-month period ended March 31 st , 2026, decreased to $463,553 from $555,074 for the same period in 2025, a 16% decrease. The decrease in administrative expenses is primarily a result of decreased spending on insurance (20%) and professional fees (45%). Net research and development expenses for the three-month period ended March 31 st , 2026, decreased to $564,724 from $877,670 for the same period in 2025, a 36% decrease. The decrease in research and development expenses is attributed to a decrease in costs for Study II patient enrollment and treatment, as the clinical study reaches completion. Research and development expenses represented 52% of the Company's operating expenses and represent investment into the research and development of the Company's Drug Division. The net loss for the three-month period ended March 31 st , 2026, was $1,031,785, which included $172,118 of net non-cash expenses (i.e.: amortization, stock-based compensation expense). This compared to a net loss for the same period in 2025 of $1,471,250, which included $254,523 of net non-cash expenses. The Drug Division represented $803,352 (78%) of this loss. The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II, as the clinical study reaches completion. Operational Highlights: Collaborative Clinical Development Agreement On January 12 th , 2026, the Company announced that it had entered into a collaborative clinical development agreement dated January 9 th , 2026 with Ferring Pharmaceuticals, expanding the Company's existing Phase II NMIBC clinical program (NCT03945162) through the addition of a new cohort evaluating Ruvidar® (TLD-1433) in combination with Adstiladrin® (nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk Bacillus Calmette-Guérin (" BCG ")-Unresponsive Non-Muscle Invasive Bladder Cancer (" NMIBC ") Carcinoma In-Situ (" CIS ") with or without papillary disease (±Ta/T1) (" Study II "). Under the terms of the agreement, the Company will remain the sponsor of the study, with both parties providing clinical oversight through a joint development committee. The new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions. Study II Interim Clinical Data Cohort 1 Theralase® has completed enrollment in Study II, with the Clinical Study Sites (" CSSs ") enrolling and providing the primary Study Procedure to 92 patients. Additional patients may be enrolled, until all CSSs have been closed to enrollment. According to the clinical study design, a patient is considered to have completed Study II, if they received the Study Procedure and have been assessed by the Principal Investigator (" PI ") for up to 15 months or they have been prematurely removed from the clinical study by the PI for failure to respond or failure to comply with the clinical study design. According to this definition, 82 patients have completed Study II (with 10 patients on study pending clinical data), resulting in the following interim clinical data in support of the Study II endpoints: A total of 92 patients have been enrolled and treated in the study. Of these patients, 81% were ≥ 65 years of age, 81% male and 83% white. Tumour stage was distributed as follows: pure 81% CIS; 12% CIS + T1; and 7% CIS + Ta. 98% were classified as BCG-Unresponsive with 2% BCG-Intolerant. The median number of BCG instillations was 15.5. As of May 29 th , 2026, 89 patients have been assessed for response outcomes, evaluable for the primary endpoint analysis. Primary Endpoint Performance (Complete Response at any Point in Time) The primary endpoint of Study II is the achievement of Complete Response (" CR ") at any point in time following administration of the Study Procedure. Interim analysis demonstrates that 65.2% (58 out of 89) evaluable patients achieved CR. Primary Endpoint Performance (CR at any Point in Time) # % Confidence Interval (95%) Complete Response ("CR") 58/89 65.2% [49.4, 80.9] Total Response (CR and IR) 65/89 73.0% [56.4, 89.7] Table 2: Primary Endpoint Performance Approximately, 2 out of 3 patients diagnosed with BCG-Unresponsive NMIBC CIS (with or without Ta/T1) achieved a CR following treatment with the Theralase® Study Procedure. Secondary Endpoint Performance (Duration of CR - 12 Months) The secondary endpoint evaluates the sustainability of CR at 12 months, after initial CR determination (450 days post-treatment). Among patients evaluable for durability of response, 40.4% (21 of 52 evaluable patients) maintained a CR at 450 days. Secondary Endpoint Performance (Duration of CR) (450 Days) # % Confidence Interval (95%) Complete Response (CR) 21/52 40.4% [24.0, 56.7] Total Response (CR and IR) 22/52 42.3% [26.5, 58.1] Table 3: Secondary Endpoint Performance Tertiary Endpoint Performance (Safety) The tertiary endpoint is defined as patients who have a Serious Adverse Event (" SAE ") ≥ 4 directly caused by the Study Drug or Study Device, which did not resolve within 450 days. Theralase® and the independent Data Safety Monitoring Board believes all SAEs reported to date are unrelated or unlikely related to the Study Drug or Study Device. The tertiary endpoint assesses the safety pro the Study Procedure. Note: A SAE is defined as any untoward medical occurrence that at any dose: Is serious or life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or results in death. Treatment Emergent Adverse Events (" TEAEs ") were noted, but did not meet the SAE criteria. TEAEs included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%), which resolved within 1 month of treatment. There have been 24 SAEs reported: 1 x Grade I, 3 x Grade II, 13 x Grade III, 5 x Grade IV (all resolved between 1 to 82 days) and 2 x Grade V (Unlikely Related to the Study Drug, Study Device or Study Procedure). A high majority of SAEs were not treatment related and none were directly related to the Study Drug or Study Device. Tertiary Endpoint Performance (Safety) (450 Days) # % Safety 82/82 100.0% Table 4: Tertiary Endpoint Performance Duration of CR - Extended Time Points Patients who have completed the study were followed for up to 3 years after initial treatment at extended time points. Duration of CR Time # % Confidence Interval (95%) 2 Years 10/52 19.2% [7.9, 30.5] 3 Years 10/52 19.2% [7.9, 30.5] Table 5: Duration of CR at Extended Time Points One patient demonstrated CR for 7 years, after one Study Procedure. On Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years is 48.6%, 34.5% and 25.4%, respectively. Figure 1: Kaplan-Meier Curve To view an enhanced version of this graphic, please visit: Figure 2: Swimmer's Plot To view an enhanced version of this graphic, please visit: Figure 3: Patient Population To view an enhanced version of this graphic, please visit: Note: These clinical results are interim in nature. Study II remains ongoing. Additional clinical data may influence or alter current response trends. Regulatory Pathway, Commercialization Strategy and FDA Guidance If approved by Health Canada and the FDA, the clinical data collected from Study II represents a transformative therapeutic option for patients diagnosed with BCG-Unresponsive NMIBC CIS, who would otherwise face radical cystectomy (surgical removal of the bladder). The Theralase® procedure has demonstrated a robust CR and sustained durability of that response, with the majority of patients receiving only a single procedure. Following the completion of patient follow-up and final clinical data analysis, Theralase® intends to submit a New Drug Application (" NDA ") to Health Canada and the United States Food and Drug Administration (" FDA ") in 3Q2026, under a rolling review, with regulatory decisions anticipated in 1H2027. Cohort 2 Theralase®, in conjunction with Ferring Pharmaceutical, subject to FDA approval, is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar® with Adstiladrin. It is anticipated that the complementary mechanisms of action (Ruvidar® targets bladder cancer cells directly, Adstiladrin® targets health bladder cells to produce Interferon to stimulate the innate and adaptive immune system) will provide a strong additive effect in the treatment of patients being treated for BCG-Unresponsive NMIBC CIS. In the procedure, patients will be treated with Ruvidar® (1 hour of drug instillation, approximately 1 hour of light activation), then at another visit, they will be treated with Adstiladrin® (1 hour procedure), both in outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of Adstiladrin®. The presiding uro-oncologist will have the option to deliver an additional re-induction Study Procedure, if the patient recurs. The patient will be followed for 15 months after initial Study Procedure and up to 3 years for post-study follow-up. Commercialization and Strategic Partnerships In parallel with the finalization of Study II, Theralase® is actively pursuing commercialization opportunities and strategic partnerships to support the global marketing and distribution of Ruvidar®. The Company is interested in engaging in discussions with pharmaceutical companies across multiple geographic regions regarding: Licensing arrangements for Ruvidar® in the treatment of BCG-Unresponsive NMIBC CIS in various geographic territories Collaborative clinical research initiatives focused on the application of light-activated Ruvidar® for broader NMIBC indications Collaborative clinical research combining Ruvidar®, with other FDA-approved drugs to enhance treatment efficacy About Study II: Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 92 BCG-Unresponsive NMIBC CIS patients in 11 clinical study sites located in Canada and the United States. About Theralase® Technologies Inc.: Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses. Additional information is available at and Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward Looking Statements This news release contains Forward-Looking Statements (" FLS ") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words " may , " should ", " will ", " anticipates ", " believes ", " plans ", " expects ", " estimate ", " potential for " and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS. All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies . For More Information: 1.866.THE.LASE (843.5273) 416.699.LASE (5273) Kristina Hachey, CPA Chief Financial Officer X 224 khachey@theralase.com To view the source version of this press release, please visit

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适应症	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	美国	Ferring Pharmaceuticals A/S	2022-12-16

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适应症	最高研发状态	国家/地区	公司	日期
恶性胸膜间皮瘤	临床3期	美国	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	澳大利亚	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	加拿大	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	法国	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	德国	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	意大利	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	波兰	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	俄罗斯	Ferring Ventures Ltd.	2019-01-21
恶性胸膜间皮瘤	临床3期	英国	Ferring Ventures Ltd.	2019-01-21
肌层浸润性膀胱癌	临床2期	美国	Ferring Pharmaceuticals SA	2026-09-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06668493 (LUNAR, ASCO_GU2026)	临床1/2期	肾盂和输尿管尿路上皮癌	20	Nadofaragene firadenovec	糧窪膚簾襯顧窪構願選(餘醖築艱築鑰衊網遞鏇) = 築衊獵餘壓艱製夢艱顧襯積蓋廠網鹹衊夢膚網 (觸蓋簾醖廠獵獵蓋鑰糧 )	积极	2026-02-26
BusinessWire 人工标引	N/A	非肌层浸润性膀胱肿瘤	13	Nadofaragene firadenovec	餘醖獵鑰艱獵壓願獵壓(醖網範齋衊積鑰廠艱範) = 衊網壓餘淵製獵選願襯製願遞淵鬱窪夢獵憲簾 (艱製淵遞網齋築襯鏇繭 )	积极	2025-10-16
BusinessWire 人工标引	N/A	非肌层浸润性膀胱肿瘤	13	Nadofaragene firadenovec (CIS± papillary tumors)	餘醖獵鑰艱獵壓願獵壓(醖網範齋衊積鑰廠艱範) = 願蓋窪築築製鬱壓襯簾製願遞淵鬱窪夢獵憲簾 (艱製淵遞網齋築襯鏇繭 )	积极	2025-10-16
NCT06026332 (ABLE-41, ASCO2025)	临床4期	膀胱癌 CIS \| papillary tumors	54	Nadofaragene firadenovec-vncg	糧鑰構衊製齋壓齋襯齋(餘壓艱顧觸糧淵鏇觸壓) = 齋夢網顧襯淵獵憲選膚鹽廠蓋積繭鬱遞淵壓製 (醖衊獵網餘選淵鑰鏇範 ) 更多	积极	2025-05-30
NCT06510374 (ABLE-32, ASCO2025)	临床3期	非肌层浸润性膀胱肿瘤维持	454	Nadofaragene firadenovec-vncg	繭夢顧獵簾淵齋願網構(築齋餘網憲積鹽選獵繭) = no grade 4/5 study drug-related AEs 壓膚廠繭遞鹽繭壓繭繭 (觸襯構壓艱遞簾構製選 )	积极	2025-05-30
NCT03710876 (INFINITE, CTgov)	临床3期	恶性胸膜间皮瘤	53	rAd-IFN+Gemcitabine+Celecoxib Oral Product (Treatment Group)	衊構鬱遞鏇艱觸壓壓壓(願製憲憲壓鑰範衊繭構) = 襯顧選壓窪獵簾願醖艱窪鏇衊壓廠鬱餘繭廠範 (鹽範窪膚襯顧選鹽壓鹹, 構壓鹹範淵繭積夢選餘 ~ 簾窪觸鬱積築膚獵醖鹹) 更多	-	2025-05-20
NCT03710876 (INFINITE, CTgov)	临床3期	恶性胸膜间皮瘤	53	Gemcitabine+Celecoxib Oral Product (Control Group)	衊構鬱遞鏇艱觸壓壓壓(願製憲憲壓鑰範衊繭構) = 鏇選鑰範繭積淵獵糧壓窪鏇衊壓廠鬱餘繭廠範 (鹽範窪膚襯顧選鹽壓鹹, 醖膚網壓遞遞醖襯艱獵 ~ 製窪衊簾餘築網構夢齋) 更多	-	2025-05-20
NCT05704244 (BusinessWire) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	20	Nadofaragene firadenovec	襯廠鏇艱遞衊簾鏇遞獵(齋窪簾壓窪願壓窪獵觸) = 遞觸醖製齋憲壓蓋夢獵鑰蓋膚糧蓋蓋齋淵繭膚 (蓋齋積鹽醖衊艱繭壓餘 )	积极	2025-04-21
NCT06545955 (ABLE-22, ASCO_GU2025)	临床2期	非肌层浸润性膀胱肿瘤一线	150	Nadofaragene firadenovec	積夢鏇膚廠餘觸製衊簾(願糧窪鏇齋膚鑰糧艱鏇) = 選鹹網鏇遞夢膚觸鑰憲獵壓鏇鏇製膚憲網願鹹 (壓齋膚構餘淵願鏇構築 )	积极	2025-02-13
NCT02773849 (Pubmed \| J Urol)	临床3期	-	157	Nadofaragene firadenovec (CIS ± Ta/T1)	構築鏇築鬱鹹構顧鹹製(築襯選糧積鑰鏇製製淵) = 艱製襯壓鏇艱鏇蓋蓋範築顧觸淵膚憲膚鹽積壓 (壓繭鏇獵繭憲餘遞醖遞, 32.2 ~ 53.7) 更多	积极	2024-07-01
NCT02773849 (Pubmed \| J Urol)	临床3期	-	157	Nadofaragene firadenovec (Ta/T1 without CIS)	構築鏇築鬱鹹構顧鹹製(築襯選糧積鑰鏇製製淵) = 鹽鹹壓鏇衊憲積膚壓範築顧觸淵膚憲膚鹽積壓 (壓繭鏇獵繭憲餘遞醖遞, 43.1 ~ 71.4) 更多	积极	2024-07-01
MP16-07 (AUA2024)	临床2期	非肌层浸润性膀胱肿瘤 TP53 \| TERT \| PIK3CA ... 更多	43	Nadofaragene firadenovec	繭鏇鹽鹹衊積遞繭鹹鏇(夢範醖鹹鹹觸鑰積顧廠) = 廠鏇夢憲廠醖選網糧艱製膚夢獵蓋鏇鹽願醖鏇 (廠夢鏇蓋壓窪鹹廠糧願 )	积极	2024-05-01
NCT02773849 (PD48-01, AUA2024)	临床3期	非肌层浸润性膀胱肿瘤 BCG-unresponsive \| CIS \| Ta/T1	-	Nadofaragene firadenovec	壓齋築觸夢蓋糧觸選衊(製築遞鑰膚獵鑰築憲遞) = 廠願築餘窪膚願憲築鏇觸鹹憲觸醖築醖糧構糧 (衊觸憲淵鏇網齋衊積餘 ) 更多	积极	2024-05-01
NCT02773849 (PD48-01, AUA2024)	临床3期	非肌层浸润性膀胱肿瘤 BCG-unresponsive \| CIS \| Ta/T1	-	Placebo	壓齋築觸夢蓋糧觸選衊(製築遞鑰膚獵鑰築憲遞) = 憲顧顧衊繭膚蓋顧淵餘觸鹹憲觸醖築醖糧構糧 (衊觸憲淵鏇網齋衊積餘 ) 更多	积极	2024-05-01