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.

Start Date28 May 2025

Sponsor / Collaborator

IMPACT Biotech Ltd

NCT05919238

/ RecruitingPhase 1

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.

Start Date15 May 2024

Sponsor / Collaborator

IMPACT Biotech Ltd

NCT04620239

/ RecruitingPhase 3

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

This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment

Start Date22 Mar 2021

Sponsor / Collaborator

Steba Biotech NV

[+2]

100 Clinical Results associated with Padeliporfin

100 Translational Medicine associated with Padeliporfin

100 Patents (Medical) associated with Padeliporfin

Literatures (Medical) associated with Padeliporfin

30 Jan 2025·INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE

Proteomics Reveals Mechanisms of Delayed Keratoconus Progression: A Study of Corneas Following Two Light-Activated Crosslinking Treatments

Article

Author: Marcovich, Arie L. ; Mohren, Ronny ; Scherz, Avigdor ; Brandis, Alexander ; Vogels, Demi H. J. ; LaPointe, Vanessa L. S. ; Dickman, Mor M. ; Cillero-Pastor, Berta ; Brekelmans, Jurriaan ; Vos, Naomi R. N.

Purpose:

This study aims to elucidate on changes in biological pathways in rabbit corneas induced by two methods of light-activated corneal stiffening: topical application of riboflavin with dextran (RF-D) or WST11 with dextran (WST-D) followed by ultraviolet A (UVA) or near-infrared (NIR) illumination, respectively.

Methods:

Rabbit corneas were mechanically de-epithelialized, then left untreated (N = 3) or treated with either RF-D/UVA (N = 3) or WST-D/NIR (N = 3). After one week, quantitative proteomics was performed on untreated, RF-D/UVA- and WST-D/NIR-treated corneas. Pathway enrichment analysis was performed to identify the biological processes associated with the treatments. To identify the abundance and spatial distribution of lipids in the untreated, WST-D/NIR- and RF-D/UVA-treated corneal stroma, lipid mass spectrometry imaging was performed together with hematoxylin and eosin staining.

Results:

Between RF-D/UVA- and WST-D/NIR-treated corneas, 37 and 39 proteins, respectively, were differentially expressed compared to untreated corneas (P < 0.05). Pathway enrichment analysis showed the effect of RF-D/UVA treatment on cell metabolism and terminal differentiation of keratocytes, while WST-D/NIR modified extracellular matrix regulation and the mitogen-activated protein kinase signaling cascade. When comparing the RF-D/UVA and WST-D/NIR treatment, 74 proteins were differentially expressed, affecting cellular metabolism and respiration, complement activation, the activation of matrix metalloproteinases, and lipoprotein metabolism. The lipid profile for the RF-D/UVA- and WST-D/NIR-treated stromas were similar, whereas differences were observed comparing both treatments to untreated corneal stroma.

Conclusions:

Proteomics indicated a metabolic shift from oxidative phosphorylation to glycolysis and hypoxia after RF-D/UVA treatment. In contrast, WST-D/NIR stiffening maintained normal respiration and involved extracellular matrix remodeling.

30 Sep 2023·Translational andrology and urology

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

Review

Author: Gottlieb, Josh ; Linehan, Jennifer ; Murray, Katie S

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.

01 May 2023·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

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

Purpose::

Vascular-targeted photodynamic therapy 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. This Phase I trial (NCT03617003) evaluated the safety of vascular-targeted photodynamic therapy with WST-11 in upper tract urothelial carcinoma.

Materials and Methods::

Nineteen patients underwent up to 2 endoscopic vascular-targeted photodynamic therapy treatments, with follow-up for up to 6 months. Patients who had residual or recurrent upper tract urothelial carcinoma (any grade/size) failing prior endoscopic treatment or unable or unwilling to undergo surgical resection were eligible for inclusion. The primary endpoint was to identify the maximally tolerated dose of laser light fluence. A dose escalation model was employed, with increasing light fluence (100-200 mW/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 posttreatment.

Results::

Fourteen (74%) patients received the maximally tolerated dose of 200 mW/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::

Vascular-targeted photodynamic therapy with WST-11 has an acceptable safety profile with strong potential as an effective, kidney-sparing endoscopic management option for upper tract urothelial carcinoma. The recently initiated multicenter Phase 3 ENLIGHTED trial (NCT04620239) is expected to provide further evidence on this therapy.

News (Medical) associated with Padeliporfin

22 May 2025

·www.einpresswire.com

ImPact Biotech Announces Late-Breaking Podium Presentation at ASCO 2025 Highlighting ENLIGHTED Study Interim Analysis

-- Company to present interim update from ENLIGHTED Phase 3 Study in LG UTUC following assessment of 50% of targeted total evaluable patient enrollment -- TEL AVIV, Israel, May 22, 2025 (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 will present an interim analysis with updated data from the ongoing Phase 3 ENLIGHTED study evaluating Padeliporfin VTP in patients low-grade upper tract urothelial cancer (UTUC) in a late-breaking podium session at the American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3, 2025 in Chicago, Illinois. “Evaluation of Padeliporfin VTP in the ENLIGHTED study continues to steadily progress as we work to complete enrollment in the second half of 2025 and push towards potentially registrational topline results later this year,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We believe this interim analysis, capturing 50% of the targeted enrollment of evaluable patients, will continue to support the robust value proposition for Padeliporfin VTP in UTUC as a best-in-class, paradigm shifting treatment option for patients currently underserved by the standard of care. We look forward to sharing these results and future updates as the data matures.” Podium Presentation Details: Poster Title: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC): ENLIGHTED phase 3 study Presenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical Center Poster Number: LBA4513 Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma Session Date & Time: May 31, 2025, 1:15 PM CT About ENLIGHTED The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care follow-up visits every three months with optional VTP therapy administered on each visit for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. 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: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com . Contacts Global Head of Business Development Guy Schmidt guy.schmidt@impactbiotech.com Precision AQ John Norton john.norton@precisionaq.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3ASCO

28 Apr 2025

·www.globenewswire.com

ImPact Biotech Presents Updated Efficacy Data from Evaluation of Padeliporfin VTP in LG UTUC and Intermediate-Risk Prostate Cancer at AUA 2025

– Complete response (CR) observed in 79% (26/33) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP) of the ENLIGHTED Phase 3 trial evaluating Padeliporfin VTP in UTUC – – Padeliporfin VTP treatment continues to be safe and efficacious, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase (MTP) – – Additional podium presentation reinforces platform applicability across solid tumors and highlights robust, long-term durability of response out to 48 months post-treatment with Padeliporfin VTP in intermediate-risk prostate cancer – TEL AVIV, Israel, April 28, 2025 (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 updated preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), as well as long-term follow up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk of prostate cancer. These data were presented at the American Urological Association’s 2025 Annual Meeting (AUA) on April 27, 2025 in Las Vegas, Nevada. “Positive updates from the ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to shift the treatment paradigm as a promising non-invasive option for patients with low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We are highly encouraged by the robust complete response rate, which is in line with other minimally invasive interventions but without incurring risk of organ injury or loss. We also see potential for deepening of partial responses in a real-world setting, where retreatment may be possible beyond the number of inductions included in trial protocol. We look forward to sharing additional updates from the ENLIGHTED study, and anticipate reporting complete topline data within the year to support potential registration of Padeliporfin VTP in this indication.” Key updated preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP: As of November 4, 2024, the data cut-off for the poster presentation at AUA, 44 patients had begun treatment, of which 33 had completed ITP and were evaluable for efficacy. Clinical Profile: 26 of the 33 (79%) response-evaluable patients achieved a CR at the end of ITP.6 of the 33 (18%) response-evaluable patients achieved a partial response (PR) at the end of ITP. Safety and Tolerability Profile: Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results.Adverse events (AEs) observed were primarily Grade 1 or 2, most of which were related to the ureteroscopic procedure rather than VTP, and all resolved within two to seven days. Only one patient experienced a Grade 3 serious adverse event that was related to the VTP therapy, which resolved within two days, and there were no VTP related Grade 4 or 5 serious adverse events observed. ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment in mid-2025. Long-term follow-up from PCM-204 Phase 2b trial in intermediate-risk prostate cancer: In addition to updates from the ENLIGHTED study, the Company delivered an oral presentation on 48-month follow-up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk prostate cancer. 46 of the 50 (92%) of patients included in the study were assessable at the 48-month follow-up interval. “We are further excited by the updates from longer-term evaluation in men with intermediate-risk prostate cancer, extending prior observations in low-risk prostate cancer for which Padeliporfin VTP has previously been approved,” Dr. Morag continued. “These data further underscore the potential of our technology’s applicability across solid tumors and, importantly, provide visibility into the durability of response to treatment with Padeliporfin VTP.” Efficacy Profile: 32 off the 46 (69%) of the evaluable men remained free from evidence of clinical disease progression at 48 months post-treatment. Functional Outcomes and Safety: Padeliporfin demonstrated minimal long-term toxicity including low impact on urinary and sexual function, consisted with the safety and tolerability profile established in the Phase 3 trial in low-risk disease. Functional outcomes at 48 months post-treatment included a non-significant mean decrease in IIEF-5 scores from baseline of -0.67 (standard deviation [SD] 4.4).IPSS demonstrated an average non-significant change of -0.34 (SD 5.1).All patients maintained pad-free urinary continence. Padeliporfin VTP (brand name Tookad) has previously been approved by the European Union, Israel, and Mexico as a treatment for low-risk prostate cancer, following demonstration of significant clinical benefit as a localized partial gland ablation (PGA) therapy when compared to active surveillance for low-risk prostate cancer. Podium and Poster Session Details: Poster Title: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): ENLIGHTED Phase 3 StudyPresenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical CenterPoster Number: IP-12-14Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma Podium Session Title: 48-Month Follow up of Results of the PCM-204 Phase 2b Trial of Partial-Gland Ablation for Men with Intermediate-Risk Prostate Cancer with Padeliporfin (WST11 or Tookad) Vascular-Targeted Photodynamic TherapyPresenter: Jonathan Fainberg, Urologic Surgeon, Memorial Sloan Kettering Cancer CenterPodium Session Number: PD19-06 About ENLIGHTEDThe Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. About ImPact BiotechImPact 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: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com. Contacts Global Head of Business DevelopmentGuy Schmidtguy.schmidt@impactbiotech.com Precision AQJosh Rappaportjosh.rappaport@precisionaq.com

Clinical ResultPhase 3Phase 2

15 Apr 2025

·www.globenewswire.com

ImPact Biotech Announces New Data Presentations at AUA 2025 Highlighting Safety and Efficacy of Padeliporfin VTP

- Company to present updated preliminary results from ENLIGHTED Phase 3 Study in LG UTUC - - Additional podium presentation to provide updates from long-term evaluation of Padeliporfin VTP in intermediate-risk prostate cancer - April 11, 2025 -- 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 will present updated preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), as well as long-term follow up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk of prostate cancer, at the American Urological Association’s 2025 Annual Meeting taking place April 26-29, 2025 in Las Vegas, Nevada. “We are excited for the opportunity to share positive updates from the ENLIGHTED trial, which we believe will continue to reinforce Padeliporfin VTP’s potential to shift the treatment paradigm as a promising non-invasive option for patients with low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We also look forward to presenting results from longer-term evaluation of Padeliporfin VTP in intermediate-risk prostate cancer, where our mechanism of action is already well-understood in low-risk disease. ImPact continues to progress evaluation of Padeliporfin VTP in LG UTUC and other solid tumor indications, and we anticipate completing enrollment of the ENLIGHTED trial in 2nd half of 2025.” Poster Title: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): ENLIGHTED Phase 3 Study Presenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical Center Poster Number: IP-12-14 Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma Session Date & Time: April 27, 2025, 1:00 PM Podium Session Title: 48-Month Follow up of Results of the PCM-204 Phase 2b Trial of Partial-Gland Ablation for Men with Intermediate-Risk Prostate Cancer with Padeliporfin (WST11 or Tookad) Vascular-Targeted Photodynamic Therapy Presenter: Jonathan Fainberg, Urologic Surgeon, Memorial Sloan Kettering Cancer Center Podium Session Number: PD19-06 Session Date and Time: April 27, 2025, 4:10 PM The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across over 20 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed via a ureteroscope, applying laser fiber illumination for 10 minutes in the close vicinity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care 3 month follow ups, alongside potential single VTP treatment, for up to 12 months. The study’s primary objective is to assess the efficacy and response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. 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: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

100 Deals associated with Padeliporfin

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KEGG	Wiki	ATC	Drug Bank
-	Padeliporfin	L01XD07	DB15575

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Adenocarcinoma of prostate	European Union	Steba Biotech NV	10 Nov 2017
Adenocarcinoma of prostate	Iceland	Steba Biotech NV	10 Nov 2017
Adenocarcinoma of prostate	Liechtenstein	Steba Biotech NV	10 Nov 2017
Adenocarcinoma of prostate	Norway	Steba Biotech NV	10 Nov 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 3	United States	Steba Biotech NV	22 Mar 2021
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 3	Austria	Steba Biotech NV	22 Mar 2021
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 3	France	Steba Biotech NV	22 Mar 2021
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 3	Germany	Steba Biotech NV	22 Mar 2021
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 3	Israel	Steba Biotech NV	22 Mar 2021
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 3	Spain	Steba Biotech NV	22 Mar 2021
Transitional cell cancer of the renal pelvis and ureter recurrent	Phase 3	United States	Steba Biotech NV	22 Mar 2021
Transitional cell cancer of the renal pelvis and ureter recurrent	Phase 3	Austria	Steba Biotech NV	22 Mar 2021
Transitional cell cancer of the renal pelvis and ureter recurrent	Phase 3	France	Steba Biotech NV	22 Mar 2021
Transitional cell cancer of the renal pelvis and ureter recurrent	Phase 3	Germany	Steba Biotech NV	22 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04620239 (UCM301 \| ENLIGHTED, GlobeNewswire) Manual	Phase 3	Transitional Cell Carcinoma	44	Padeliporfin VTP	isaakalkof(yfcdoktbrq) = edvvwgmlok rqfbusbrib (emtnhtdupm ) View more	Positive	28 Apr 2025
NCT03315754 (PCM-204, GlobeNewswire) Manual	Phase 2	Prostatic Cancer	46	Padeliporfin VTP	nvkcqvzloy(loabfzhtjr) = eqzvsnebfm aeckhlljer (fknnnihbcs ) View more	Positive	28 Apr 2025
NCT04620239 (ENLIGHTED, GlobeNewswire) Manual	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma	20	Padeliporfin VTP	wvrmnsvgqb(germtzaalw) = hhcxbyfjzd bmtramxqcs (ooqphtdqji )	Positive	04 Dec 2024
NCT04620239 (UCM301 \| ENLIGHTED, GlobeNewswire) Manual	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma	14	Padeliporfin VTP	iphudifmth(dgqjnqjvas) = womexzbfxc uutyrxopwj (djxprpukks )	Positive	07 Nov 2024
NCT04620239 (ENLIGHTED, Biospace) Manual	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma	13	Padeliporfin	rvrluianad(bqraxipdcd) = hdvppmixta vmilpuqdvd (qbxomtwjmg ) View more	Positive	02 Jun 2024
NCT04620239 (ENLIGHTED, Biospace) Manual	Phase 3	Transitional Cell Carcinoma	9	Padeliporfin	cassqyvrrc(anhsrxivfc) = dtkpngeurw pbvngvdylf (rtoibokosh )	Positive	06 May 2024
NCT03315754 (PCM-204, CTgov)	Phase 2	Localized Prostate Carcinoma	50	TOOKAD Soluble 4 mg/kg	tjjywoliut = rfmiwfuibw rdlbzsoztx (lgxfrlywta, tttbnnwyxf - iuwelpnzvh) View more	-	02 Aug 2023
NCT03315754 (ASCO 12021 \| ASCO 22021) Manual	Phase 2	Prostatic Cancer	46	padeliporfin	wifccpfrgo(fllpcnyuqc) = qpyysbaoca eelyxgvgyc (qzepsuexki ) View more	Positive	28 May 2021
NCT03617003 (ASCO_GU2021) Manual	Phase 1	Renal Pelvis and Ureter Urothelial Carcinoma	14	phototherapy +WST11	dugqvszswr(gjvvlgdstu) = plvmjocypj bmcjualaqz (zagthglbqr ) View more	Positive	20 Feb 2021
NCT01310894 (CLIN1001 PCM301, Pubmed \| Lancet Oncol) Manual	Phase 3	Prostatic Cancer	-	Padeliporfin	odrthjhyps(yvcuplokvy) = duisdarikt yoiapzikso (iulswdxwdi ) View more	Positive	01 Feb 2017
NCT01310894 (CLIN1001 PCM301, Pubmed \| Lancet Oncol) Manual	Phase 3	Prostatic Cancer	-	active surveillance	odrthjhyps(yvcuplokvy) = ydsycfcefk yoiapzikso (iulswdxwdi ) View more	Positive	01 Feb 2017

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis