Pilot Phase 1-2 Investigational Study to Assess the Efficacy and Safety of Recombinant Hyaluronidase (rHUPH20) in the Treatment of Secondary Lymphedema Resulting From Local Management of Malignancy

This phase 1-2 trial studies the side effects and the best dose of recombinant human hyaluronidase and to see how well it works in treating lymphedema in patients with cancer. Recombinant human hyaluronidase (r-hu-hyaluronidase, rHuPH20) may reduce limb edema size in patients with lymphedema.

开始日期2013-12-01

申办/合作机构

Stanford University

[+1]

NCT00318643

/ Completed临床1/2期

A Phase 1-2a, Multicenter, Open-Label, Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of Recombinant Human Hyaluronidase (Chemophase®) in Combination With Mitomycin in Patients With Non-Muscular-Invasive Bladder Cancer

The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). Chemophase is being specifically developed for use with other anticancer drug to increase the local penetration of the anticancer drug for the treatment of superficial bladder cancer. In this study, Chemophase will be given in combination with mitomycin C directly into the bladder. Mitomycin C is an anti-tumor drug that is commonly used to treat superficial bladder cancer. It is envisioned that Chemophase with mitomycin C may potentially increase the local penetration of mitomycin C into remaining cancer cells following surgery to treat superficial bladder cancer.

开始日期2006-03-30

申办/合作机构

Halozyme Therapeutics, Inc.

100 项与 Hyaluronidase/Mitomycin 相关的临床结果

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100 项与 Hyaluronidase/Mitomycin 相关的转化医学

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100 项与 Hyaluronidase/Mitomycin 相关的专利（医药）

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项与 Hyaluronidase/Mitomycin 相关的文献（医药）

2021-01-01·International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group2区 · 医学

Loco-regional deep hyperthermia combined with intravesical Mitomycin instillation reduces the recurrence of non-muscle invasive papillary bladder cancer

2区 · 医学

ArticleOA

作者: Fan, Yen-Chun ; Lin, Yung-Wei ; Lai, Benjamin Chung Howe ; Lin, Ke-Hsun ; Syu, Syuan-Hao ; Lee, Liang-Ming ; Lee, Hsin-Lun ; Shih, Hung-Jen ; Wen, Yu-Ching

OBJECTIVES:

To compare the therapeutic effects of locoregional deep hyperthermia combined with intravesical chemotherapy with those of intravesical chemotherapy alone in patients with intermediate-/high-risk non-muscle invasive bladder cancer (NMIBC). To evaluate the impact of thermal dose in hyperthermia treatment.

METHODS:

We analyzed data retrieved from the medical records of patients with intermediate-/high-risk NMIBC treated with intravesical mitomycin (IM group) or locoregional deep hyperthermia combined with intravesical mitomycin (CHT group) at a single tertiary care hospital between May 2016 and June 2019. The primary and secondary endpoints were the recurrence-free survival rate and progression-free survival rate, respectively. Thermal dose was evaluated and adverse events were also recorded.

RESULTS:

In total, 43 patients (CHT: 18 patients, IM: 25 patients) were enrolled. The median follow-up durations were 14 and 23 months, respectively. The recurrence rate at 12 months was significantly lower in the CHT group than in the IM group (11.1% vs. 44%, p = .048); this trend persisted at 24 months (CHT: 11.1%, IM: 48%; p = .027). The recurrence-free survival was also significantly higher in the CHT group than in the IM group (p = .028). No tumor recurrence was noted in patients who received a thermal dose of ≥4 CEM43. All adverse events were well tolerated, and there was no treatment-related mortality.

CONCLUSIONS:

Intravesical chemotherapy combined with locoregional deep hyperthermia for intermediate-/high-risk papillary NMIBC can significantly decrease the recurrence rate relative to that observed after intravesical chemotherapy alone.

项与 Hyaluronidase/Mitomycin 相关的新闻（医药）

2026-07-08

·allsci.com

UroGen’s UGN-501 oncolytic virus gains FDA clearance for non-muscle invasive bladder cancer trial

UroGen Pharma (Nasdaq: URGN) announced on July 8, 2026 that the US FDA cleared its Investigational New Drug application for UGN-501, an oncolytic virus designed for intravesical delivery in patients with non-muscle invasive bladder cancer (NMIBC). The UGN-501 FDA clearance enables the company to initiate a Phase 1 clinical trial, with patient enrollment expected to begin in Q4 2026. NMIBC is among the most prevalent urological malignancies, and its management is complicated by high recurrence rates even after standard treatment. The disease spans a spectrum of risk — from low-grade papillary tumors to carcinoma in situ (CIS) — and despite an expanding roster of approved therapies, a meaningful proportion of patients continue to experience recurrence or progression. Cystectomy, the definitive surgical option, carries substantial morbidity, and bladder-sparing alternatives remain an active area of development. The approved landscape has expanded considerably in recent years. Merck’s BCG live (Tice BCG) remains the first-line standard of care for intermediate- and high-risk disease following transurethral resection of bladder tumor. For patients whose disease does not respond to BCG, options now include Merck & Co.’s pembrolizumab (Keytruda) administered intravenously, Ferring Pharmaceuticals’ nadofaragene firadenovec-vncg (Adstiladrin) — a non-replicating adenoviral gene therapy delivering interferon-alpha 2b — ImmunityBio’s nogapendekin alfa inbakicept-pmln (Anktiva) combined with BCG, and most recently Janssen Biotech’s gemcitabine intravesical system (Inlexzo), approved in September 2025. UroGen itself received approval in June 2025 for mitomycin intravesical solution (Zusduri), a sustained-release hydrogel formulation targeting recurrent low-grade intermediate-risk NMIBC. Against this backdrop, UGN-501 represents UroGen’s push into a mechanistically distinct space: replication-competent oncolytic virus therapy for bladder cancer, a modality not yet represented among approved NMIBC treatments. UGN-501 (ICVB-1042) is an engineered oncolytic adenovirus that exploits aberrant E2F transcription factor activity — a hallmark of tumor cells — to drive selective viral replication within cancer cells. Normal urothelial tissue, which maintains regulated E2F activity, is designed to be spared. Viral replication within tumor cells leads to direct cell lysis, and the resulting immunogenic cell death is intended to trigger a secondary anti-tumor immune response. This dual mechanism — direct cytotoxicity combined with local immune activation — is the defining rationale for the program. Nonclinical data cited by UroGen demonstrated cytotoxic activity across a broad panel of bladder cancer cell lines representing multiple disease stages and grades, though the company has not publicly disclosed the specific parameters or comparative benchmarks from those studies. The planned Phase 1 clinical trial will assess the safety, tolerability, and feasibility of intravesical UGN-501 administration in NMIBC patients, with no public listing available for the study at present. The oncolytic virus field in bladder cancer has no currently approved representative, making UGN-501 an early mover in this specific modality for NMIBC. Within NMIBC specifically, the closest mechanistic neighbor is nadofaragene firadenovec, which uses a non-replicating adenoviral vector to deliver a therapeutic gene locally. UGN-501 is designed to actively replicate within tumor cells, amplifying its cytotoxic effect in situ, whereas nadofaragene firadenovec functions as a one-time gene delivery vehicle without viral replication. Complete response rates in the BCG-unresponsive CIS setting for currently approved agents range from roughly 40% to 62% at six months, with durability remaining a challenge across the class. An oncolytic approach that generates durable local immune memory, if validated clinically, could offer a meaningful complement or alternative to existing options. UGN-501 is UroGen’s third clinical-stage asset and its first in the oncolytic virus modality. The company’s two approved products — Zusduri and its upper tract urothelial cancer therapy — both rely on the proprietary RTGel reverse-thermal hydrogel platform for sustained local drug delivery. UGN-501 does not use RTGel; it represents a distinct biological approach within the same disease focus. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

临床申请临床1期上市批准基因疗法临床研究

2025-06-12

·药明康德

近80%患者肿瘤3个月后完全消失！FDA批准创新疗法

今日，美国FDA批准UroGen Pharma公司开发的膀胱内注入用丝裂霉素溶液Zusduri，用于治疗复发性低级别中等风险非肌层浸润性膀胱癌（LG-IR-NMIBC）成年患者。根据新闻稿，这是FDA批准首个针对该适应症的药物。膀胱癌主要发生于老年人群，患者确诊的中位年龄为73岁，且通常伴有多种合并症。目前临床指南将经尿道膀胱肿瘤切除术（TURBT）列为非肌层浸润性膀胱癌（NMIBC）的标准治疗方式。然而，NMIBC的复发率高，约70%的患者至少会经历一次复发，其中低级别中等风险（LG-IR）患者复发概率更高，往往需要多次接受TURBT治疗。FDA此次对药物的批准主要基于在ENVISION试验中的积极有效性数据。这是一项单臂、多中心临床试验，共纳入240名在接受TURBT后复发的低级别NMIBC成年患者，患者符合以下一到两项标准：多个肿瘤、携带＞3厘米的单一肿瘤和/或在1年内复发。患者每周接受一次75毫克丝裂霉素膀胱内注入治疗，连续6周。患者通过膀胱镜检查、有指征时的活检及尿细胞学检查，每3个月评估一次肿瘤状况。▲UGN-102分子结构（图片来源：PubChem）主要疗效终点为3个月时的完全缓解率（CR）和缓解持续时间（DOR）。CR被定义为膀胱镜检查和尿细胞学检查均未发现疾病迹象。如有必要，则会进行活检确认。分析显示，在223例可评估疗效的患者中，78%（95% CI：72-83）达到CR。DOR范围为0至25个月以上，其中79%的应答患者在至少12个月内维持缓解状态。包括实验室检查异常在内的最常见不良反应（≥10%）有肌酐升高、钾升高、排尿困难、血红蛋白下降、天冬氨酸氨基转移酶升高、丙氨酸氨基转移酶升高、嗜酸细胞升高、淋巴细胞减少、泌尿道感染、中性粒细胞减少和血尿。其中12%的患者出现严重不良反应，包括尿潴留（0.8%）和尿道狭窄（0.4%）。另有1名患者出现致死性心力衰竭不良反应。▲UroGen公司专有的RTGel技术能够维持药物在靶组织中的浓度（图片来源：UroGen公司官网）Zusduri（曾用名UGN-102）是一种创新的丝裂霉素膀胱内注入溶液。该产品采用UroGen自主研发的RTGel技术，这是一种基于水凝胶的持续释放平台，旨在通过延长膀胱组织与丝裂霉素的接触时间来治疗肿瘤。在门诊环境下，医护人员可通过导尿管将Zusduri直接注入患者膀胱，实现非手术方式的肿瘤治疗。参考资料：[1] FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Retrieved June 12, 2025 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle[2] U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC). Retrieved June 12, 2025 from https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床研究上市批准

2025-06-04

·PRNewswire

INVESTOR ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In UroGen To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $75,000 in UroGen between July 27, 2023 and May 15, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, June 4, 2025 /PRNewswire/ -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against UroGen Pharma Ltd. ("UroGen" or the "Company") (NASDAQ: URGN) and reminds investors of the July 28, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Continue Reading Faruqi & Faruqi Logo (PRNewsfoto/Faruqi & Faruqi, LLP) Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See . As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On May 16, 2025, before the market opened, the U.S. Food and Drug Administration ("FDA") published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's new drug application ("NDA") for UGN-102, which stated the agency doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In the briefing document, the FDA stated: "[g]iven that [the ENVISION trial] lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret." The FDA also said it had "recommended a randomized trial design to the Applicant several times during their product's development due to concerns with interpreting efficacy results" but UroGen "chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate." On this news, UroGen's stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, on unusually heavy trading volume. Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, UroGen's stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding UroGen's conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the UroGen Pharma Ltd. class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. SOURCE Faruqi & Faruqi, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

申请上市

100 项与 Hyaluronidase/Mitomycin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06205

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床2期	美国	Halozyme Therapeutics, Inc.	2006-03-30

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临床结果

适应症

分期

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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


NCT00318643 (CTgov)	临床1/2期	非肌层浸润性膀胱肿瘤	27	Mitomycin C+Chemophase (Cohort 5: MMC Plus Chemophase 800,000 U)	衊膚廠艱襯窪餘壓夢壓 = 鑰遞蓋窪築壓鬱鬱簾網膚餘鑰鹽窪遞膚餘網夢 (構鏇蓋網鏇廠網觸範範, 製積艱淵顧鹽淵憲獵淵 ~ 襯簾顧廠鬱築餘鬱窪範) 更多	-	2021-10-29
NCT00318643 (CTgov)	临床1/2期	非肌层浸润性膀胱肿瘤	27	Mitomycin C+Chemophase (Cohort 1: MMC Plus Chemophase 20,000 U)	醖簾網積衊繭壓鏇蓋壓 = 壓遞範觸鬱範鏇遞蓋衊獵壓遞築壓顧餘選夢憲 (醖鏇醖鏇願淵遞蓋憲糧, 遞艱遞膚獵鬱簾鹽廠選 ~ 遞鹹醖鹽選願艱鏇醖獵) 更多	-	2021-10-29
NCT01928030 (CTgov)	临床1/2期	肿瘤 \| 淋巴水肿	3	rHuPH20+Chemophase	鹹範衊積蓋獵壓簾觸廠(憲淵鏇蓋壓憲顧構製淵) = 願醖齋艱鹽鹹窪糧壓艱憲鏇簾製網餘選衊願鑰 (襯窪襯窪願夢觸壓築範, 蓋鑰衊壓製願顧遞願鏇 ~ 憲淵鬱觸顧齋餘餘鑰夢) 更多	-	2017-02-07