维因塔基(BioCancell Therapeutics, Inc.)(Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.))

概要

基本信息

药物类型

基因疗法

别名

diphtheria-toxin-A-H19、Inodiftagene Vixteplasmid、Inodiftagene vixteplasmid

+ [5]

靶点

白喉毒素

作用机制

Diphtheria Toxin modulators

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [1]

在研适应症-

非在研适应症

局部晚期胰腺腺癌非肌层浸润性膀胱肿瘤非肌层浸润性膀胱尿路上皮癌+ [3]

原研机构

BioCancell Therapeutics, Inc.

在研机构-

非在研机构

Anchiano Therapeutics Israel Ltd.

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 29258282

来源: *****

关联

7

项与维因塔基(BioCancell Therapeutics, Inc.) 相关的临床试验

NCT03719300

/ Terminated临床2期

A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

开始日期2019-03-20

申办/合作机构

Anchiano Therapeutics Israel Ltd.

NCT01878188

/ Completed临床1期

Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)
Recurrence after treatment with BC-819/PEI and BCG
Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder
After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

开始日期2013-02-01

申办/合作机构

Anchiano Therapeutics Israel Ltd.

NCT01413087

/ Terminated临床2期

A Multi-Center, Open-Label, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma

This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following intratumoral administration of BC-819 and intravenously administered gemcitabine. Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).
Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival.
Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on:
Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life, Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival

开始日期2011-09-01

申办/合作机构

Anchiano Therapeutics Israel Ltd.

100 项与维因塔基(BioCancell Therapeutics, Inc.) 相关的临床结果

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100 项与维因塔基(BioCancell Therapeutics, Inc.) 相关的转化医学

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100 项与维因塔基(BioCancell Therapeutics, Inc.) 相关的专利（医药）

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11

项与维因塔基(BioCancell Therapeutics, Inc.) 相关的文献（医药）

2020-04-01·Clinica chimica acta; international journal of clinical chemistry3区 · 医学

Long non-coding RNA in bladder cancer

3区 · 医学

Review

作者: Zheng, Shuyun ; Wu, Xiaoli ; Xie, Kaipeng ; Wang, Chao ; Cao, Yuepeng ; Xu, Hanzi ; Li, Weijian ; Wu, Wanke ; Wu, Xuhong ; Zhan, Chuanfei ; Tian, Tian

Bladder cancer (BC) is the ninth most common malignant disease and ranks fourteenth in cancer mortality worldwide. Moreover, among cancers, the incidence and mortality of BC in males increased to the 6th and 9th place, respectively. The overall survival (OS) declines dramatically as the cancer progresses, especially when urothelial cells transition from noninvasive to invasive. It is well known that epithelial cells can acquire invasive properties and a propensity to metastasize through the epithelial-to-mesenchymal transition (EMT) process in tumourigenesis and progression. However, the potential molecular mechanisms and key pathways are still unclear. As the sequencing technology advances, long non-coding RNAs (lncRNAs) have been proven to play an important role in regulating biological processes and cellular pathways. Here, we reviewed important lncRNAs, such as H19, UCA1 and MALAT1, that participate in the malignant phenotype of BC and regulate EMT signalling networks in the invasion-metastasis cascade during BC development. We further discuss MALAT1, PCAT-1 and SPRY4-IT1, and also urine and blood exosomal H19 and PTENP as potential noninvasive biomarkers. Moreover, antisense oligonucleotides (ASOs) and a double-stranded DNA plasmid (BC-819) have been designed for use in preclinical cancer models and clinical trials in patients. Therefore, the results of investigations have gradually prompted the utility of lncRNAs.

2017-03-01·Archives of gynecology and obstetrics4区 · 医学

A phase 1/2a, dose-escalation, safety, pharmacokinetic, and preliminary efficacy study of intraperitoneal administration of BC-819 (H19-DTA) in subjects with recurrent ovarian/peritoneal cancer

4区 · 医学

Article

作者: Lavie, Ofer ; Fishman, Ami ; Levy, Tally ; Segev, Yakir ; Raveh, Eli ; Gilon, Michal ; Hochberg, Avraham ; Edelman, David ; Hubert, Ayala

BACKGROUND:

H19 is a paternally imprinted, oncofetal gene expressed in various embryonic tissues and in 85% of the ovarian tumors. H19-DTA (BC-819) is a DNA plasmid that drives the expression of the diphtheria toxin gene under the regulation of the H19 promoter sequence and therefore is a potential treatment for various tumors that overexpress the H19 gene, among them-ovarian cancer.

OBJECTIVE:

To assess the safety and efficacy of intra-peritoneal (IP) instillations of H19-DTA (BC-819) plasmid in treating ovarian/peritoneal cancer patients with advanced recurrent disease.

METHODS:

A phase 1-2A multi-centric trial included 14 eligible patients who were either platinum-refractory or platinum-resistant with positive H19 expression. Patients were treated IP with escalating weekly doses of BC-819 for a maximum of 6-9 weeks. Dose-limiting toxicities (DLT) were assessed after the first course of treatment for each patient and each subsequent cohort was enrolled once each subject had completed the first course of treatment and its 4-week follow-up period. The occurrence of adverse events (AEs) and response to treatment were assessed after the induction course and then periodically.

RESULTS:

During the study, no DLTs were observed. Only 5 grade 1 and 2 AEs, which occurred in 4 patients were considered as possibly related to BC-819. The best tumor response seen was stable disease. Median survivals of 3.2, 5.3 and 6.5 months were observed for the 60, 120 and 240 mg cohorts, respectively.

CONCLUSIONS:

BC-819 can be considered safe and well tolerated in intraperitoneal doses up to 240 mg. Hybridization of intraperitoneal chemotherapy with the biological treatment of BC-819 should be further evaluated in phase 2 and 3 studies.

2014-06-01·The Journal of urology1区 · 医学

DNA Based Therapy with Diphtheria Toxin-A BC-819: A Phase 2b Marker Lesion Trial in Patients with Intermediate Risk Nonmuscle Invasive Bladder Cancer

1区 · 医学

Article

作者: Lamm, Donald L. ; Dotan, Zohar ; Halachmi, Sarel ; Yutkin, Vladimir ; Ehrlich, Nahum ; Gofrit, Ofer N. ; Benjamin, Shalva ; Leibovitch, Ilan ; Hochberg, Abraham ; Ben-Am, Monique

PURPOSE:

H19 is a paternally imprinted oncofetal gene expressed in various embryonic tissues and in 85% of bladder tumors but suppressed in the adult healthy bladder. BC-819 is a DNA plasmid that carries the gene for diphtheria toxin-A under regulation of the H19 promoter sequence. We assessed the efficacy and toxicity of intravesical BC-819 instillations to prevent tumor recurrence and ablate a marker lesion in a phase 2b trial.

MATERIALS AND METHODS:

A total of 47 patients with recurrent, multiple nonmuscle invasive bladder tumors in whom prior intravesical therapy had failed underwent transurethral resection of all except 1 marker tumor. Patients expressing H19 received a 6-week induction course of intravesical BC-819. Patients who achieved a complete response (absent new tumors at 3 months) were given 3 maintenance courses of 3-weekly instillations every 3 months.

RESULTS:

All patients were evaluable for adverse effects and 39 were evaluable for efficacy. Complete tumor ablation was achieved in 33% of patients and in 64% there were no new tumors at 3 months. Median time to recurrence was 11.3 months in all cases but significantly longer (22.1 months) when analyzed by response status at 3 months. Adverse events were mild. The study was limited by the small number of patients.

CONCLUSIONS:

BC-819 prevented new tumor growth in two-thirds of the patients and ablated a third of the marker lesions. Prolonged time to recurrence was observed in responding patients. These results along with the good safety profile make BC-819 a potential medication for bladder cancer.

1

项与维因塔基(BioCancell Therapeutics, Inc.) 相关的新闻（医药）

2022-11-28

·Business Wire

2022 Bladder Cancer Update Bulletin: Key Opinion Leader (KOL) Views on Recent Developments - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Bladder Cancer: Update Bulletin #2" newsletter has been added to ResearchAndMarkets.com's offering. This edition presents leading key opinion leader (KOL) views on recent developments in the Bladder Cancer market. Topics covered include: Bristol-Myers Squibb (BMS) presenting positive data from a Phase I/II study investigating a combination of its PD-1 inhibitor Opdivo (nivolumab) with its pipeline indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, BMS-986205, in heavily pretreated patients with advanced bladder cancer; BioCanCell announcing final results for its Phase IIb combination trial investigating its lead compound BC-819 in combination with the BCG vaccine in 38 patients with intermediate-and high-risk non-muscle invasive bladder cancer (NMIBC); KOLs offering their updated opinions on the the supply status of the BCG vaccine in the US and key European markets. Business Questions: How do the KOLs perceive the Phase II combination results for BMS' Opdivo with the IDO inhibitor BMS-986205 in patients with advanced bladder cancer? Do KOLs view PD-1/PD-L1 and IDO inhibition as a viable combination approach going forward? What are experts' thoughts on PD-L1 expression and its future use as a biomarker in patients with bladder cancer? Do KOLs hold any other concerns about dual immunotherapy combinations such as cost, access or increased risk of toxicity? If approved, how and when would KOLs consider using the combination approach of Opdivo with an IDO inhibitor? Based on published Phase II data, how do the experts view the results so far for BC-819 with BCG in patients with NMIBC? Are the KOLs enthusiastic about intravesical gene therapies as treatments for NMIBC and if so, why? How do the experts perceive the planned Phase III trial investigating BC-819 in patients that are BCG-recurrent? If approved, can BC-819 gain market share in patients with high-risk or intermediate-risk NMIBC? What are KOLs' opinions on the supply shortages previously reported for the BCG vaccine and are they being addressed? For more information about this newsletter visit https://www.researchandmarkets.com/r/9ke1kl

临床2期疫苗免疫疗法临床结果ASCO会议

100 项与维因塔基(BioCancell Therapeutics, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16017

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期胰腺腺癌	临床2期	美国	Anchiano Therapeutics Israel Ltd.	2011-09-01
局部晚期胰腺腺癌	临床2期	以色列	Anchiano Therapeutics Israel Ltd.	2011-09-01
胰腺腺癌	临床2期	美国	Anchiano Therapeutics Israel Ltd.	2011-09-01
胰腺腺癌	临床2期	以色列	Anchiano Therapeutics Israel Ltd.	2011-09-01
不能切除性胰腺癌	临床2期	美国	Anchiano Therapeutics Israel Ltd.	2009-08-01
不能切除性胰腺癌	临床2期	以色列	Anchiano Therapeutics Israel Ltd.	2009-08-01
复发性铂耐药性卵巢癌	临床2期	以色列	Anchiano Therapeutics Israel Ltd.	2009-06-01
非肌层浸润性膀胱肿瘤	临床2期	美国	Anchiano Therapeutics Israel Ltd.	2008-01-01
非肌层浸润性膀胱肿瘤	临床2期	以色列	Anchiano Therapeutics Israel Ltd.	2008-01-01
非肌层浸润性膀胱尿路上皮癌	临床1期	以色列	Anchiano Therapeutics Israel Ltd.	2013-02-01

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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


NCT03719300 (CTgov)	临床2期	非肌层浸润性膀胱肿瘤	32	inodiftagene vixteplasmid	顧遞鹽鏇淵網網夢淵憲(築鹽餘願構構鹹積醖顧) = 獵餘糧廠鹽衊簾網鑰繭衊選衊淵鹽齋餘淵遞獵 (選壓糧壓範觸窪衊醖願, 壓淵築獵築製齋鹹製獵 ~ 醖衊簾鹽構醖蓋築構鑰) 更多	-	2020-08-19
NCT01413087 (LAPC-BC-819, CTgov)	临床2期	胰腺腺癌 \| 局部晚期胰腺腺癌	12	Biological/Vaccine: BC-819 (8 mg BC-819 and Gemcitabine)	壓網鏇鬱鏇選衊築壓鹽(遞夢廠築淵襯鏇獵顧簾) = 鬱築顧鬱網壓鏇範鑰齋齋窪遞窪鏇膚糧廠鹽獵 (觸鑰顧積繭壓鏇鹹糧蓋, 膚願顧鏇獵窪衊鹹襯觸 ~ 網夢艱窪選餘壓襯構築) 更多	-	2019-11-01
NCT01413087 (LAPC-BC-819, CTgov)	临床2期	胰腺腺癌 \| 局部晚期胰腺腺癌	12	Biological/Vaccine: BC-819 (12 mg BC-819 and Gemcitabine)	壓網鏇鬱鏇選衊築壓鹽(遞夢廠築淵襯鏇獵顧簾) = 構壓獵蓋獵壓選範網積齋窪遞窪鏇膚糧廠鹽獵 (觸鑰顧積繭壓鏇鹹糧蓋, 餘鹹築糧範夢觸築繭壓 ~ 衊醖蓋淵艱繭顧夢網夢) 更多	-	2019-11-01
NCT01878188 (ASCO_GU2018)	临床2期	非肌层浸润性膀胱肿瘤	38	BC-819 and BCG	觸遞構膚醖廠顧艱壓艱(齋壓製鏇艱憲積艱獵構) = 觸顧製獵齋醖艱構構簾醖繭選鏇壓憲糧膚蓋夢 (鬱構壓壓憲願觸蓋遞構 ) 更多	积极	2018-02-26
NCT00711997 (CTgov)	临床1/2期	不能切除性胰腺癌	9	BC-819 (BC-819 4 mg)	築製鹽積鹽餘壓構鑰艱(齋鹽顧遞範願鏇餘選網) = 艱糧艱襯網鑰淵築鏇鹹鹹鬱選觸選齋廠繭製積 (築簾鬱遞鑰膚遞範淵鏇, 願鏇淵憲製鑰鏇衊窪簾 ~ 壓艱網鏇網簾網蓋淵顧) 更多	-	2013-12-02
NCT00711997 (CTgov)	临床1/2期	不能切除性胰腺癌	9	BC-819 (BC-819 8 mg)	築製鹽積鹽餘壓構鑰艱(齋鹽顧遞範願鏇餘選網) = 窪鬱醖繭遞襯醖築範遞鹹鬱選觸選齋廠繭製積 (築簾鬱遞鑰膚遞範淵鏇, 窪夢遞遞壓廠鹹構艱壓 ~ 鏇襯艱蓋築築簾艱築壓) 更多	-	2013-12-02
NCT00595088 (CTgov)	临床2期	非肌层浸润性膀胱肿瘤	47	BC-819/PEI	構鬱憲淵齋遞廠襯齋繭(淵顧鹽壓簾壓膚淵製繭) = 製糧齋獵窪鏇簾糧鏇蓋構鹽網願獵蓋餘淵鑰鑰 (襯餘餘糧鹽繭淵憲襯襯, 獵窪繭醖醖鹽製鹹淵憲 ~ 構繭廠壓餘鹹壓蓋構膚) 更多	-	2013-08-21