A Multicenter Open-label Phase 1/1b Study to Evaluate Safety, Feasibility and Early Treatment Effect of Padeliporfin VTP Using Robotic Assisted Bronchoscopy and Cone Beam CT Guidance in Patients With Peripheral Lung Cancer

Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects.
Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Surgery will be performed at 5-21 days following the VTP procedure.
Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.

开始日期2024-05-30

申办/合作机构

IMPACT Biotech Ltd

NCT05919238 / Not yet recruiting临床1期

A Multicenter Open-label Phase 1 Trial to Evaluate Safety and Preliminary Efficacy of Endovascularly Applied Vascular Targeted Photodynamic Therapy (VTP) for Patients With Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma

This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the superior mesenteric artery (SMA) in patients with stage III, locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

开始日期2024-04-30

申办/合作机构

IMPACT Biotech Ltd

EUCTR2020-004494-41-AT / Unknown status临床3期

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low-Grade Upper Tract Urothelial Cancer - ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

开始日期2022-10-14

申办/合作机构

Steba Biotech SA

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100 项与帕利泊芬相关的专利（医药）

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项与帕利泊芬相关的文献（医药）

2023-09-30·Translational andrology and urology

Advances in chemoablation in upper tract urothelial carcinoma: overview of indications and treatment patterns.

Review

作者: Josh Gottlieb ; Jennifer Linehan ; Katie S Murray

Localized upper tract urothelial carcinoma (UTUC) is a difficult disease for clinicians to treat, due to the multitude of oncological and patient factors to consider. Despite the challenges of diagnostic staging, endoscopic management, and disease recurrence, there is still a need for local therapeutic options that do not subject patients to the morbidities of radical nephroureterectomy (RNU). Intraluminal chemotherapies have allowed for improved oncological control in patients with low-grade disease receiving renal-sparing treatment approaches. This narrative review discusses the treatment modalities available for localized low-grade UTUC, with a focus on the current status of chemoablation. The OLYMPUS trial was a pivotal study that lead to the Food and Drug Administration (FDA) approval of UGN-101 (mitomycin-C) in April 2020 for the treatment of low-grade UTUC, and intraluminal chemotherapy is now a widely used modality for managing this disease. The trial reported a complete response (CR) rate of 59%, and an estimated treatment durability of 82% at 1 year. However, a concern was the reported 44% ureteral stricture rate using the retrograde approach. More research is currently underway to determine the ideal instillation method for intraluminal therapies (e.g., retrograde vs. antegrade). Lastly, we discuss upcoming treatment options. Newer novel agents like padeliporfin vascular targeted photodynamic (VTP) therapy (brand name TOOKAD) are currently being studied, which will in hope provide additional treatment options for UTUC patients.

2023-02-01·The Journal of urology

Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-Targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma.

Article

作者: Wesley Yip ; Daniel D Sjoberg ; Lucas M Nogueira ; Andrew T Tracey ; Ricardo G Alvim ; Peter A Reisz ; Quinlan Demac ; Nicole E Benfante ; Rand W Vanden Berg ; Kwanghee Kim ; Hikmat Al-Ahmadie ; Oscar Lin ; Bernard H Bochner ; Guido Dalbagni ; S Machele Donat ; Eugene J Pietzak ; A Ari Hakimi ; David B Solit ; Avigdor Scherz ; Dean F Bajorin ; Jonathan A Coleman

PURPOSE:

Vascular-targeted photodynamic therapy (VTP) with the intravascular photosensitizing agent padeliporfin (WST-11/TOOKAD-Soluble) has demonstrated therapeutic efficacy as an ablative treatment for localized cancer with potential adaptation for endoscopic management of upper tract urothelial carcinoma (UTUC). This phase I trial (NCT03617003) evaluated the safety of VTP with WST-11 in UTUC.

MATERIALS AND METHODS:

Nineteen patients underwent up to 2 endoscopic VTP treatments, with follow-up for up to 6 months. Patients who had residual or recurrent UTUC (any grade/size) failing prior endoscopic treatment or were unable or unwilling to undergo surgical resection were eligible for inclusion. The primary endpoint was to identify the maximally tolerated dose (MTD) of laser light fluence. A dose escalation model was employed, with increasing light fluence (100-200mW/cm) using a modified continual reassessment method. The secondary endpoint was treatment efficacy, defined by absence of visible tumor and negative urine cytology 30 days post-treatment.

RESULTS:

Fourteen (74%) patients received the MTD of 200mW/cm, 2 (11%) of whom experienced a dose-limiting toxicity. The initial 30-day treatment response rate was 94% (50% complete, 44% partial). Eight patients underwent a second treatment, with a final observed 68% complete response rate. Leading toxicities were flank pain (79%) and hematuria (84%), which were transient. No ureteral strictures associated with treatment were identified during follow-up.

CONCLUSIONS:

VTP with WST-11 has an acceptable safety profile with strong potential as an effective, kidney-sparing endoscopic management option for UTUC. The recently initiated multi-center phase 3 ENLIGHTED trial (NCT04620239) is expected to provide further evidence on this therapy.

2022-10-04·Journal of nanobiotechnology

Emerging photodynamic/sonodynamic therapies for urological cancers: progress and challenges.

Review

作者: Xiao Hu ; Yu-Sen Zhang ; Yi-Chao Liu ; Na Wang ; Xian-Tao Zeng ; Ling-Ling Zhang

Photodynamic therapy (PDT), and sonodynamic therapy (SDT) that developed from PDT, have been studied for decades to treat solid tumors. Compared with other deep tumors, the accessibility of urological tumors (e.g., bladder tumor and prostate tumor) makes them more suitable for PDT/SDT that requires exogenous stimulation. Due to the introduction of nanobiotechnology, emerging photo/sonosensitizers modified with different functional components and improved physicochemical properties have many outstanding advantages in cancer treatment compared with traditional photo/sonosensitizers, such as alleviating hypoxia to improve quantum yield, passive/active tumor targeting to increase drug accumulation, and combination with other therapeutic modalities (e.g., chemotherapy, immunotherapy and targeted therapy) to achieve synergistic therapy. As WST11 (TOOKAD® soluble) is currently clinically approved for the treatment of prostate cancer, emerging photo/sonosensitizers have great potential for clinical translation, which requires multidisciplinary participation and extensive clinical trials. Herein, the latest research advances of newly developed photo/sonosensitizers for the treatment of urological cancers, and the efficacy, as well as potential biological effects, are highlighted. In addition, the clinical status of PDT/SDT for urological cancers is presented, and the optimization of the photo/sonosensitizer development procedure for clinical translation is discussed.

项与帕利泊芬相关的新闻（医药）

2023-12-20

·BioSpace

ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer

Phase 1 clinical trial expected to initiate in 1H 2024 – IND clearance in third indication reflects broad platform potential for Padeliporfin VTP across a range of solid tumors – TEL AVIV, Israel, Dec. 20, 2023 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat a range of solid tumors, today announced that the Company’s Investigational New Drug (IND) application for Padeliporfin VTP has been cleared by the U.S. Food and Drug Administration (FDA) to begin a Phase 1 study in patients with unresectable pancreatic adenocarcinoma (PDAC). “We are excited to explore the potential of Padeliporfin VTP in addressing the tremendous unmet need in locally advanced pancreatic cancer and look forward to initiating this study in the first half of next year,” said Barak Palatchi, CEO of ImPact Biotech. “Moreover, alongside our ongoing pivotal study in upper tract urothelial cancer and plans to evaluate Padeliporfin VTP in non-small cell lung cancer, clearance of this IND reflects broadly held conviction in our platform as a non-surgical alternative with potential to improve outcomes and expand the treatable population of patients across a range of solid tumors.” The Phase 1 study is a two-part, multi-center, non-randomized, open-label clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of Padeliporfin VTP therapy in patients with Stage 3, locally advanced and unresectable PDAC. Part A will deploy a 3+3 dose-escalation design assessing the safety and tolerability of Padeliporfin VTP at ascending doses of VTP administered endovascularly via optical fiber in combination with Padeliporfin administered intravenously at a fixed dose. Part B will enroll an expansion cohort, to dose at the maximum tolerated dose and/or recommended dose for expansion identified in Part A, with the primary objective to evaluate preliminary efficacy. About Padeliporfin VTP Padeliporfin VTP (Vascular Targeted Photodynamic) therapy is a minimally invasive oncology platform for the treatment of solid tumors. It offers surgery-like efficacy combined with healthy-tissue or organ preservation. VTP comprises the intravenous delivery of an inactive drug, Padeliporfin. Upon light activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which in-turn enhances cancer cell eradication. About ImPact Biotech ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: Contacts Global Head of Business Development Guy Schmidt guy.schmidt@impactbiotech.com Stern Investor Relations, Inc. Josh Rappaport Josh.rappaport@sternir.com

临床3期临床申请临床1期

2023-12-18

·BioSpace

ImPact Biotech Announces Appointment of Eyal Morag, M.D. as Chief Medical Officer

TEL AVIV, Israel, Dec. 18, 2023 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat a range of solid tumors, today announced the appointment of Eyal Morag, M.D., as Chief Medical Officer (CMO). Dr. Morag brings extensive experience as a practicing clinical radiologist, specializing in image-guided minimally invasive procedures, as well as extensive leadership experience developing and establishing radiology related businesses. “We are thrilled to announce Eyal’s appointment as our Chief Medical Officer,” said Barak Palatchi, ImPact Biotech’s Chief Executive Officer. “With numerous years of leadership, both as a clinical radiologist and biotech entrepreneur, Dr. Morag’s background offers a rich combination that will be immeasurable as we seek to translate our vision for ImPact into reality for patients.” Dr. Morag joins ImPact from Microbot Medical Ltd., where he served as Chief Medical Officer. Currently, he also serves in scientific and medical advisory roles at Aidoc Medical, Vortex Imaging and HighRad. Previously, Dr. Morag co-founded InTek Technology and Global Versa Radiology (GVR), for which he also served as Chief Medical Officer and Vice President. Earlier in his career, Dr. Morag held leadership roles earlier as a clinical radiologist as the Chairman of the Department of Radiology and Nuclear Medicine at Assuta Ashdod Medical Center, Regional Radiology Director for Mercy Health Partners in Toledo, OH and Chief of Radiology at Holyoke Medical Center in Holyoke, MA. Dr. Morag earned his M.D. from the Boston University School of Medicine and completed a fellowship in Cardiovascular and Interventional Radiology at Beth Israel Deaconess Medical Center and Harvard Medical School. He is certified both by the American Board of Radiology and the Israeli Ministry of Health. “I am pleased to be joining ImPact Biotech at this critical juncture in the company’s growth,” said Dr. Eyal Morag. “I am particularly encouraged by data from Padeliporfin VTP which thus far demonstrate its potential as a minimally invasive, alternative treatment for patients whose cancer is unresectable. I look forward supporting advancement of this program through the ongoing pivotal study in UTUC and for treatment of other solid tumors.” About ImPact Biotech ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: Contacts Global Head of Business Development Guy Schmidt guy.schmidt@impactbiotech.com Stern Investor Relations, Inc. Josh Rappaport Josh.rappaport@sternir.com

高管变更临床3期

2023-08-14

·Pharmaceutical Technology

ImPact enters partnership for pathologic myopia therapy development

Pathologic myopia, or myopic macular degeneration, is a severe eye disease. Credit: Serafino Mozzo / Shutterstock.com. Israeli biotech organisation ImPact Biotech has entered a research partnership with Maastricht University in the Netherlands to develop a therapy for arresting the progression of pathologic myopia or myopic macular degeneration (MMD), a severe eye disease. The organisation will work with two researchers from the university, associate professor Dr Mor Dickman and MERLN Institute associate professor Dr Vanessa LaPointe. Recommended Reports Reports LOA and PTSR Model - Radiprodil in Neurodegenerative Diseases GlobalData Reports LOA and PTSR Model - Spebrutinib Besylate in Follicular Lymphoma GlobalData View all Companies Intelligence Maastricht University Impact BioTech Ltd View all The parties will leverage the Padeliporfin vascular targeted photodynamic (VTP) therapy platform of ImPact for developing the treatment. Padeliporfin has received the European Medicines Agency’s approval for usage in low-risk prostate cancer patients. It is currently being evaluated in a Phase III clinical trial for treating low-grade upper tract urothelial carcinoma. The organisation also plans to commence further studies of Padeliporfin in patients with non-small cell lung cancer and pancreatic cancer. ImPact Biotech Research and Development global head Dr David Perry stated: “We look forward to collaborating with Maastricht University’s Drs LaPointe and Dickman on this important research collaboration to address the huge unmet medical need in progressive myopia while leveraging our Padeliporfin VTP technology to help patients afflicted with this highly debilitating condition. “Initial results with our Padeliporfin approach are very encouraging and we are looking forward to progressing it rapidly towards clinical research by growing our understanding of the disease and the potential interventions to change its course with the contribution of this collaboration.” The organisation is also partnering with research institutes and specialists in associated areas to analyse its platform’s potential to treat pathological myopia.

临床3期上市批准

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研发状态

适应症	最高研发状态	国家/地区	公司
前列腺腺癌	批准上市	挪威更多	Steba Biotech NV 更多
肾盂输尿管移行细胞癌复发	临床3期	奥地利更多	Steba Biotech SA 更多
不能切除性胰腺癌	临床1期	-	IMPACT Biotech Ltd 更多
胰腺导管腺癌	临床1期	-	IMPACT Biotech Ltd 更多
胰腺癌	临床前	美国更多	IMPACT Biotech Ltd 更多

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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


MP59-03 (AUA2014)	N/A	-	16	WST-11 VTP	齋觸築選簾鹽廠艱築遞(鬱襯壓網遞構選繭衊鹽) = Chronic ablations showed the development of cortical fibrosis 襯蓋遞艱範鏇繭鏇遞餘 (網遞窪選憲廠膚範夢繭 ) 更多	-	2014-04-01
NCT00975429 \| NCT00707356 \| NCT01310894 (Pubmed \| World J Urol)	N/A	局限性前列腺癌	-	Tookad Soluble (Salvage radical prostatectomy)	(壓膚鬱鏇蓋鏇醖顧窪齋) = 繭衊鹽醖鏇蓋淵醖築鏇網餘壓觸齋繭餘築憲鏇 (願積網顧艱蓋繭壓構鹽 ) 更多	-	2015-07-01
NCT03315754 (CTgov)	临床2期	局限性前列腺癌	50	TOOKAD Soluble 4 mg/kg	齋餘膚製齋齋簾襯觸窪(獵窪築鏇觸齋繭積觸襯) = 範醖襯鹽窪簾齋衊選簾構遞蓋淵製範積積蓋顧 (築繭繭淵齋糧餘製顧鏇, 選選獵壓獵壓積積餘廠 ~ 範膚遞夢獵窪遞獵艱壓) 更多	-	2023-08-02
Pubmed \| BJU Int	N/A	前列腺癌	40	4 mg/kg WST11	(積顧艱鹹顧築淵顧觸餘) = not significantly different between baseline and 6 months after VTP 構遞鹹鹹齋鹽積鏇鑰獵 (壓襯網鬱夢蓋範艱糧鑰 ) 更多	-	2015-12-01
2019 ARVO Annual Meeting (ARVO2019)	N/A	-	5	WST11	繭糧範鹹鬱鑰憲鏇艱簾(鏇觸製夢鑰製鹹齋簾鏇) = 糧鹽網衊衊繭繭壓範鑰膚觸醖鏇選鑰窪鹽糧艱 (襯膚膚鏇鹽遞製夢餘壓 ) 更多	-	2019-07-01
NCT03617003 (ASCO_GU2021) 人工标引	临床1期	肾盂和输尿管尿路上皮癌	14	phototherapy +WST11	(網鬱選獵鑰餘廠鹹鑰構) = 製糧鹹蓋簾餘製顧製鑰獵構蓋築糧鬱淵夢廠觸 (鬱簾願糧顧鏇積膚夢蓋 ) 更多	积极	2021-02-20
NCT01310894 (CLIN1001 PCM301, Pubmed \| Lancet Oncol) 人工标引	临床3期	前列腺癌	-	Padeliporfin	(範製製齋製獵醖襯選憲) = 構鹹醖鹹衊簾壓蓋選範襯艱鏇築繭衊製壓醖窪 (繭願願範築範選餘夢艱 ) 更多	积极	2017-02-01
NCT01310894 (CLIN1001 PCM301, Pubmed \| Lancet Oncol) 人工标引	临床3期	前列腺癌	-	active surveillance	(範製製齋製獵醖襯選憲) = 鹽築繭夢選襯網窪願膚襯艱鏇築繭衊製壓醖窪 (繭願願範築範選餘夢艱 ) 更多	积极	2017-02-01
NCT03315754 (ASCO2021) 人工标引	临床2期	前列腺癌	46	padeliporfin	蓋鑰觸醖餘淵餘鹹繭壓(艱構蓋糧衊憲廠積淵網) = 糧蓋蓋壓繭廠憲餘積顧艱顧選襯憲選糧願醖夢 (窪鏇夢繭鑰製齋齋餘遞 ) 更多	积极	2021-05-28
NCT00975429 \| NCT00707356 \| NCT01875393 \| NCT01310894 \| NCT00946881 (Pubmed \| World J Urol)	临床2期	局限性前列腺癌	117	TOOKAD® Soluble	壓鏇淵糧夢築蓋夢鹽憲(艱構顧壓蓋簾廠衊夢廠) = 膚艱壓網鹹憲築築醖鏇鬱遞糧構憲醖襯構蓋夢 (醖鹹窪齋繭醖獵獵夢積 ) 更多	-	2015-07-01