他拉泊芬钠(Talaporfin Sodium) - 在研适应症：食管癌，脑癌，肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Aptocine、Leserfin、Litx

+ [14]

靶点-

作用方式-

作用机制

光敏剂

治疗领域

肿瘤神经系统疾病消化系统疾病+ [1]

在研适应症

食管癌脑癌肺癌

非在研适应症

乳腺癌心血管疾病脉络膜新生血管+ [17]

原研机构

Meiji Seika Pharma Co., Ltd.

在研机构

Meiji Seika Pharma Co., Ltd.

非在研机构

Light Sciences Oncology, Inc.Light Sciences, Inc.

最高研发阶段批准上市

首次获批日期

日本 (2003-10-16),

肺癌

最高研发阶段(中国)-

特殊审评孤儿药 (日本)

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结构/序列

分子式C38H41N5Na4O9

InChIKeyDSZWCAQEOJGGCM-LBARBQQXSA-N

CAS号220201-34-3

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关联

26

项与他拉泊芬钠相关的临床试验

JPRN-jRCTs041230002

/ Suspended临床2/3期IIT

Specified clinical study of the effects of photodynamic therapy using ME2906 and PNL6405CIN for patients with cervical intraepithlial neoplasia on vaginal bacteria

开始日期2023-04-05

申办/合作机构-

JPRN-jRCT2041220118

/ Recruiting临床1/2期IIT

Phase1/2 study of endoscopic photodynamic therapy using ME2906 and ultrathin PDT probe in unresectable bile duct cancer

开始日期2023-02-03

申办/合作机构-

JPRN-jRCT2021220040

/ Recruiting临床2期IIT

Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405SCT for patients with malignant spinal cord tumor.

开始日期2023-01-12

申办/合作机构-

100 项与他拉泊芬钠相关的临床结果

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100 项与他拉泊芬钠相关的转化医学

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100 项与他拉泊芬钠相关的专利（医药）

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420

项与他拉泊芬钠相关的文献（医药）

2024-12-31·Neurospine

First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol

Article

作者: Takahashi, Yoshiharu ; Sato, Aya ; Miyata, Satoshi ; Fukami, Shinjiro ; Nishizawa, Taketo ; Akimoto, Jiro ; Sasaki, Tatsuya ; Endo, Toshiki

Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).

2024-10-21·ACS Applied Bio Materials

Water-Soluble Rotaxane-Type Porphyrin Dyes as a Highly Membrane-Permeable and Durable Photosensitizer Suitable for Photodynamic Therapy

Article

作者: Iwamura, Munetaka ; Chiba, Junya ; Ohishi, Yuki ; Yamashita, Juri ; Nozaki, Koichi ; Zhou, Yue ; Ichikawa, Taiki ; Yokoyama, Satoru ; Inouye, Masahiko

Porphyrins have emerged as highly effective photosensitizers in the field of photodynamic therapy (PDT) because of their high singlet oxygen generation efficiency. However, most porphyrin derivatives do not have adequate water solubility and cell membrane permeability suitable for use in PDT. In addition, they frequently suffer from low durability under photoirradiation. Here, we propose rotaxane-type photosensitizers, in which a porphyrin axle is irreversibly encapsulated within cyclodextrins (CDs), to overcome the drawbacks of porphyrins for PDT. The rotaxane-type photosensitizers were synthesized in high yields by employing a cooperative capture strategy. The CD derivatives worked as a transparent shell to impart a porphyrin axle not only with water solubility but also with photostability. These rotaxanes showed higher cell membrane permeability and photoinduced cytotoxic abilities than talaporfin sodium, presently used as a clinical photosensitizer. The rotaxane-based photosensitizer could have potential for being ideal PDT drugs.

2024-10-01·World Neurosurgery

The Safety of Intraoperative Photodynamic Diagnosis Using 5-Aminolevulinic Acid Combined with Talaporfin Sodium Photodynamic Therapy in Recurrent High-Grade Glioma

Article

作者: Miki, Shunichiro ; Matsuda, Masahide ; Kohzuki, Hidehiro ; Tsurubuchi, Takao ; Ishikawa, Eiichi ; Sugii, Narushi ; Zaboronok, Alexander

BACKGROUNDIntraoperative photodynamic diagnosis (PDD) using 5-aminolevulinic acid (5-ALA) is a widely adopted technique to enhance the extent of resection during high-grade glioma (HGG) surgery. Recent updates to the package insert for 5-ALA in Japan now allow its use in combination with drugs that may induce photosensitivity, such as talaporfin sodium (TS). TS is employed in intraoperative photodynamic therapy (PDT) and has been shown to improve overall survival. The combination of 5-ALA with TS is expected to offer further benefits. However, the safety of this combination had not been established. This study reports on the safety of 5-ALA-PDD with TS-PDT in the treatment of recurrent HGG.METHODS7 patients with recurrent HGG underwent tumor resection using a combination of 5-ALA-PDD and TS-PDT. The incidence of photosensitivity as an adverse effect associated with 5-ALA and TS was evaluated as described in the package insert. Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.RESULTSTumor-specific fluorescence intensity was strong in 4 cases and weak in 3. Photosensitivity occurred in only 1 patient (14.3%). Three patients exhibited CTCAE grade 1 or 2 abnormal liver function, and 1 patient experienced CTCAE grade 1 γ-GTP elevation. All abnormalities improved during follow-up.CONCLUSIONSThe combined use of 5-ALA-PDD and TS-PDT for HGG surgery did not increase the risk of serious adverse events in our study. Further investigations with a larger number of cases are needed for a more accurate assessment of its safety and efficacy.

100 项与他拉泊芬钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01985	他拉泊芬钠	L01	DB11812

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
食管癌	日本	Meiji Seika Pharma Co., Ltd.	2015-05-20
脑癌	日本	Meiji Seika Pharma Co., Ltd.	2013-09-20
肺癌	日本	Meiji Seika Pharma Co., Ltd.	2003-10-16

未上市

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
不可切除的肝细胞癌	药物发现	中国香港	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	瑞典	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	韩国	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	马来西亚	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	塞尔维亚	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	波兰	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	克罗地亚	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	菲律宾	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	新加坡	Light Sciences Oncology, Inc.	2006-07-01
不可切除的肝细胞癌	药物发现	印度	Light Sciences Oncology, Inc.	2006-07-01

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临床结果

适应症

分期

评价

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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


UEGW2024	N/A	肿瘤	-	Talaporfin PDT	蓋製膚簾淵憲鏇膚壓夢(遞艱選餘網鑰夢積積艱) = 鹽艱觸獵糧積簾醖築廠鏇願願製衊積夢膚選鏇 (醖選鑰簾齋糧憲餘構鏇 ) 更多	-	2024-10-13
				Talaporfin (STING knockout cells)	蓋製膚簾淵憲鏇膚壓夢(遞艱選餘網鑰夢積積艱) = 鹽醖鏇鑰窪鑰鏇鹹網顧鏇願願製衊積夢膚選鏇 (醖選鑰簾齋糧憲餘構鏇 ) 更多
P11.10.B (EANO2023)	N/A	胶质母细胞瘤 IDH mutant \| MGMT promotor methylation	145	PDT with Talaporfin Sodium	觸襯醖糧壓襯選蓋積膚(蓋襯醖積壓範鑰餘網膚) = 1 case in PDT group 選餘糧襯壓壓簾壓選獵 (膚夢願製夢齋窪網壓窪 ) 更多	积极	2023-09-08
				Talaporfin sodium (Non-PDT Group)
SURG-27 (SNO2022)	N/A	复发性胶质母细胞瘤	-	Talaporfin sodium mediated photodynamic therapy (PDT)	膚壓簾獵鏇襯淵鹽願鹹(糧鏇觸遞鬱願窪襯窪積) = no case did treatment-related severe adverse effects 憲繭鹹憲糧觸餘壓構壓 (網製壓構膚構獵繭窪齋 )	积极	2022-11-14
				Talaporfin sodium (Maximal resection alone)
UEGW2019	N/A	食管癌	-	Talaporfin sodium	製願餘構顧鑰淵積齋糧(夢夢鏇憲鏇築獵顧夢積) = 襯餘繭襯襯壓鑰顧憲艱淵襯餘繭網選廠襯網範 (餘鑰艱醖夢製製夢獵淵 )	-	2019-10-01
ACTR-39 (SNO2016)	临床2期	胶质母细胞瘤	-	PDT with Talaporfin sodium and semiconductor laser	鬱蓋憲襯構夢鬱艱蓋簾(壓窪顧製齋夢遞衊製淵) = 構鹽廠鏇淵淵齋鏇膚觸糧鏇蓋顧壓醖範繭淵餘 (選膚築蓋願鬱齋觸膚築 ) 更多	积极	2016-11-07
				Talaporfin sodium (Surgical resection)	(襯範窪壓鬱憲獵壓鹹齋) = 淵願鹹簾蓋範鬱獵醖網窪鑰鑰糧願簾範顧網壓 (繭繭遞繭範顧觸壓襯鏇 ) 更多
NCT00440310 (CTgov)	临床3期	肝转移 \| 结直肠癌 \| 局部肿瘤复发	483	Interstitial light emitting diodes+leucovorin+irrinotecan+oxaliplatin+fluorouracil+Talaporfin sodium (Litx + Chemotherapy)	(糧齋淵鹽壓構齋窪壓構) = 簾簾糧網願鏇鹽觸繭顧窪襯衊願齋積簾鬱願觸 (構顧繭網鑰遞艱鹽夢鬱, 艱構蓋簾構築遞鬱鑰鏇 ~ 積築鹽簾醖選餘鬱觸顧) 更多	-	2015-08-25
				leucovorin+irrinotecan+oxaliplatin+fluorouracil (Chemotherapy Alone)	(糧齋淵鹽壓構齋窪壓構) = 糧選衊壓糧積網獵窪觸窪襯衊願齋積簾鬱願觸 (構顧繭網鑰遞艱鹽夢鬱, 齋願網網襯繭窪艱顧醖 ~ 廠構膚鬱鹹膚齋積憲製) 更多
JPRN-UMIN000003970 (ASCO_GI2012)	临床1期	复发性食管鳞状细胞癌 \| 食管癌	9	Talaporfin sodium-based PDT	(簾醖蓋壓窪簾蓋選顧壓) = 願壓壓繭襯範簾鹽窪選糧襯選鹽襯遞憲膚夢衊 (願積衊糧範製願選齋夢 )	-	2012-02-01
ASCO2006	N/A	肺癌	204	Laserphyrin	(醖製觸膚餘廠鏇餘淵鑰) = 襯齋憲窪願廠鬱醖壓醖簾鏇繭簾製築築夢獵範 (膚積製範淵簾遞蓋遞齋 )	-	2006-06-20
ASCO2005	临床2期	结直肠癌肝转移	10	Talaporfin sodium + intratumoral placement of LEDs	衊構醖窪繭鏇構範顧窪(餘簾壓鬱觸獵壓鹹製鹽) = 廠鬱顧遞網夢蓋壓繭範廠網願衊糧艱夢遞鏇鑰 (襯顧範艱鬱製糧簾觸襯 )	-	2005-06-01