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- Tookad (padeliporfin) / ImPact Biotech
ENLIGHTED phase 3 study: 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). (Arie Crown Theater) - Apr 23, 2025 - Abstract #ASCO2025ASCO_1256;
P3
Clinical Trial Registration Number: NCT04620239 The abstract will be released to the public on May 31, 2025 at 7:00 AM CDT
- Tookad (padeliporfin) / ImPact Biotech
Combination of gemcitabine and local tumor ablation WST-11 vascular-targeted photodynamic therapy displays superior efficacy compared to either monotherapy in a urothelial cancer model (Section 6; Poster Board No: 9) - Mar 25, 2025 - Abstract #AACR2025AACR_4878;
P1
Assessment of systemic anti-tumor responses using a bilateral tumor model, re-challenge in surviving mice and host immune effect in Rag1-/- (lacking T-cell and B-cell populations) mice bearing MB49 suggests that there is a long-term systemic immune modulation and antitumor activity enforced by the combination of VTP and gemcitabine. Additional analyses by flow cytometry and immunohistochemistry suggests that the combination of gemcitabine and VTP induces both innate and adaptive immune responses.
- Tookad (padeliporfin) / ImPact Biotech
Intravesical Vascular-Targeted Photodynamic Therapy of Urothelial Carcinomas Derived from the Oncopig Model (Casanova 501; In Person) - Mar 6, 2025 - Abstract #AUA2025AUA_2365;
VTP procedure included infusion of Padeliporfin (WST11) followed by laser illumination of tumor lesions using a frontal laser fiber at a light dose of 191 mW/cm2... Vascular-targeted photodynamic therapy shows effective ablation of urothelial carcinomas in the Oncopig model, supporting its potential for targeted intravesical cancer treatment.
- Tookad (padeliporfin) / ImPact Biotech
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 (Marco Polo 805; In Person) - Mar 6, 2025 - Abstract #AUA2025AUA_2227;
Continued follow-up to the protocol defined 5-year endpoint is pending with final 5-year results expected by early 2025. Based on the presented data, this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate risk disease.
- Tookad (padeliporfin) / ImPact Biotech
Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LGUTUC): ENLIGHTED Phase 3 study (Casanova 501; In Person) - Mar 6, 2025 - Abstract #AUA2025AUA_2078;
P1, P3
Padeliporfin VTP has shown evidence of safety and efficacy with preliminary data that is consistent with prior experience. Recruitment for the ENLIGHTED trial isongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts.
- || Tookad (padeliporfin) / ImPact Biotech
Clinical, Journal: The Safety and Efficacy of Vascular-Targeted Photodynamic Therapy in Low-Risk Prostate Cancer. (Pubmed Central) - Feb 26, 2025
Recruitment for the ENLIGHTED trial isongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts. Vascular-targeted photodynamic therapy is a safe and effective alternative to active surveillance in patients with low-risk prostate cancer.
- | Tookad (padeliporfin) / ImPact Biotech
Journal: Proteomics Reveals Mechanisms of Delayed Keratoconus Progression: A Study of Corneas Following Two Light-Activated Crosslinking Treatments. (Pubmed Central) - Jan 30, 2025
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...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.
- Tookad (padeliporfin) / ImPact Biotech
ENLIGHTED Phase 3 study: Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC) (Green Area, EGPT 1) - Jan 13, 2025 - Abstract #EAU2025EAU_3774;
- | Tookad (padeliporfin) / ImPact Biotech
Trial completion date, HEOR: CLIN1601 PCM204t: Study of the Efficacy, Safety and Quality of Life After TOOKAD (clinicaltrials.gov) - Dec 20, 2024
P2, N=50, Active, not recruiting, Sponsor: Steba Biotech S.A.
In contrast, WST-D/NIR stiffening maintained normal respiration and involved extracellular matrix remodeling. Trial completion date: Nov 2024 --> Feb 2025
- | Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial primary completion date: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - Dec 16, 2024
P1, N=30, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Nov 2024 --> Feb 2025 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
- Tookad (padeliporfin) / ImPact Biotech
ENLIGHTED Phase 3 study: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC) (Exhibition) - Nov 9, 2024 - Abstract #EMUC2024EMUC_501;
P1, P3
Conclusions Padeliporfin VTP has shown evidence of safety and efficacy with preliminary data that is consistent with prior experience. Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts.
- || Tookad (padeliporfin) / ImPact Biotech
Enrollment open: Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov) - Oct 30, 2024
P1, N=36, Recruiting, Sponsor: Impact Biotech Ltd
Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts. Suspended --> Recruiting
- ||| Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial suspension, Trial primary completion date: Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov) - Oct 3, 2024
P1, N=36, Suspended, Sponsor: Impact Biotech Ltd
Suspended --> Recruiting Trial completion date: Dec 2027 --> Dec 2028 | Not yet recruiting --> Suspended | Trial primary completion date: May 2026 --> May 2027
- || Tookad (padeliporfin) / ImPact Biotech
Enrollment open, Metastases: Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov) - Aug 27, 2024
P1, N=30, Recruiting, Sponsor: Impact Biotech Ltd
Trial completion date: Dec 2027 --> Dec 2028 | Not yet recruiting --> Suspended | Trial primary completion date: May 2026 --> May 2027 Active, not recruiting --> Recruiting
- Tookad (padeliporfin) / ImPact Biotech
Padeliporphin VTP Reverts NSCLC Orthotopic Tumors in Animal Models Into Highly Responsive to aPD1 Therapy (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1139;
Conclusions : Based on the immune landscape of the LLC tumors, timely synchronization of VTP and clinically used ICI was designed and found effective and safe for treatment of orthotopic NSCLC in mice. Similar exploration in the upcoming Phase 1 clinical trial of Padeliporfin-VTP in patients with peripheral lung cancer is expected to provide guidelines for new treatment protocols combining ICI and VTP.
- || Tookad (padeliporfin) / ImPact Biotech
Enrollment closed, Trial primary completion date, Metastases: Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov) - May 21, 2024
P1, N=30, Active, not recruiting, Sponsor: Impact Biotech Ltd
Similar exploration in the upcoming Phase 1 clinical trial of Padeliporfin-VTP in patients with peripheral lung cancer is expected to provide guidelines for new treatment protocols combining ICI and VTP. Not yet recruiting --> Active, not recruiting | Trial primary completion date: Apr 2025 --> May 2026
- Tookad (padeliporfin) / ImPact Biotech
Phase 1 study to evaluate safety and preliminary efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) in patients with locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). (Hall A; Poster Bd #: 172a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3933;
Conversion of unresectable locally advanced pancreatic cancer to surgery is a critical unmet need. This phase I trial explores a novel approach to treat the tumor encasement enabling surgery.
- Tookad (padeliporfin) / ImPact Biotech
ENLIGHTED phase 3 study: Efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) for treatment of low-grade upper tract urothelial cancer (LG UTUC). (Hall A; Poster Bd #: 309b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1787;
P1, P3
To date Padeliporfin VTP has shown evidence of safety and efficacy with preliminary data that is consistent with prior experience. Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts.
- ||| Tookad (padeliporfin) / ImPact Biotech
Trial primary completion date: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov) - Mar 17, 2024
P3, N=100, Recruiting, Sponsor: Steba Biotech S.A.
Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts. Trial primary completion date: Feb 2024 --> Dec 2024
- Tookad (padeliporfin) / ImPact Biotech
Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): Phase 3 preliminary results (303A) - Mar 12, 2024 - Abstract #AUA2024AUA_1843;
P1, P3
Padeliporfin VTP has shown evidence of safety and efficacy with preliminary data that is consistent with prior experience. Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts.
- Tookad (padeliporfin) / ImPact Biotech
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 (303B) - Mar 12, 2024 - Abstract #AUA2024AUA_1773;
Continued follow-up to the protocol defined 5-year endpoint is pending. Based on this data, this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate risk disease.
- Tookad (padeliporfin) / ImPact Biotech
aPD1 treatment of urothelial cancers is synergistically enhanced by activating anti tumor immunity using vascular targeted photodynamic therapy (Section 1) - Mar 5, 2024 - Abstract #AACR2024AACR_9464;
These observations indicate that elevating the content of anti-tumor immune cells in the tumor microenvironment by VTP in combination with ICI synergistically enhances the therapeutic effect providing a much higher complete cure compared with the individual therapies. The cure rate extent strongly depends on the synchronization of the two modalities providing guidelines for the clinical management of HG-UTUC treatment.
- || Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial initiation date, Trial primary completion date: Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov) - Mar 5, 2024
P1, N=36, Not yet recruiting, Sponsor: Impact Biotech Ltd
The cure rate extent strongly depends on the synchronization of the two modalities providing guidelines for the clinical management of HG-UTUC treatment. Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Oct 2023 --> May 2024 | Trial primary completion date: Mar 2025 --> May 2026
- || Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial initiation date, Trial primary completion date, Metastases: Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov) - Mar 5, 2024
P1, N=30, Not yet recruiting, Sponsor: Impact Biotech Ltd
Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Oct 2023 --> May 2024 | Trial primary completion date: Mar 2025 --> May 2026 Trial completion date: Oct 2025 --> Oct 2026 | Initiation date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2024 --> Apr 2025
- | Tookad (padeliporfin) / ImPact Biotech
Enrollment closed, Trial completion date, Trial primary completion date: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - Dec 14, 2023
P1, N=30, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Oct 2025 --> Oct 2026 | Initiation date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2024 --> Apr 2025 Completed --> Active, not recruiting | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
- || Tookad (padeliporfin) / ImPact Biotech, Jelmyto (mitomycin urothelial gel) / UroGen
Review, Journal: Advances in chemoablation in upper tract urothelial carcinoma: overview of indications and treatment patterns. (Pubmed Central) - Oct 10, 2023
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.
- | Tookad (padeliporfin) / ImPact Biotech
Trial completion, Trial completion date, Trial primary completion date: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - Oct 3, 2023
P1, N=30, Completed, Sponsor: Memorial Sloan Kettering Cancer Center
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. Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Oct 2023 | Trial primary completion date: Aug 2024 --> Oct 2023
- Tookad (padeliporfin) / ImPact Biotech
A novel approach to convert non-resectable pancreatic cancer with major artery involvement using endovascular activation of Padeliporfin by vascular-targeted photodynamic therapy (Level 2, Exhibit Hall D) - Sep 22, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_708;
- | Tookad (padeliporfin) / ImPact Biotech
New P1 trial: Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov) - Jun 26, 2023
P1, N=36, Not yet recruiting, Sponsor: Steba Biotech S.A.
- | Tookad (padeliporfin) / ImPact Biotech
New P1 trial, Metastases: Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov) - Jun 26, 2023
P1, N=30, Not yet recruiting, Sponsor: Steba Biotech S.A.
- | Tookad (padeliporfin) / ImPact Biotech
Enrollment closed, Trial completion date, Trial primary completion date: A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing (clinicaltrials.gov) - May 24, 2023
P1, N=12, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Oct 2023 | Trial primary completion date: Aug 2024 --> Oct 2023 Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2025
- |||| Tookad (padeliporfin) / Steba Biotech
Clinical: Now in @JUrology by @UrologyMSK @WesleyYipMD @lucasmnnogueira @preiszmd @bbmdmsk @eugene_pietzak @arihakimi et al.: Final results of a phase I trial of WST-11 (TOOKAD soluble) vascular-targeted photodynamic therapy for upper tract urothelial carcinoma https://t.co/ZoNkNfXJkc (Twitter) - May 11, 2023
- Tookad (padeliporfin) / Steba Biotech
A phase 3 multicenter study to evaluate the safety and efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) in treatment of low-grade (LG) upper tract urothelial cancer (UTUC). (On Demand | Hall A; Poster Bd # 99a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2113;
P1, P3
DSMB last reviewed the trial in Sep 2022 and suggested the trial continue as planned. Clinical trial information: NCT04620239.
- || Tookad (padeliporfin) / Steba Biotech
P1 data, Journal: Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-Targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma. (Pubmed Central) - Apr 10, 2023
P1, P3
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.
- Tookad (padeliporfin) / Steba Biotech
WST-11 vascular-targeted photodynamic therapy induced immune modulation in upper tract urothelial cancer (Section 3; Poster Board #21) - Mar 14, 2023 - Abstract #AACR2023AACR_5399;
However, the MDSC level returned close to pretreatment level in the majority of cases. The frequency of CD8 T cells among the total (CD3 positive) T cells in PBMC was increased immediately after VTP in both CR and PR.
- | Tookad (padeliporfin) / ImPact Biotech
Trial completion: A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing (clinicaltrials.gov) - Feb 27, 2023
P1, N=12, Completed, Sponsor: Memorial Sloan Kettering Cancer Center
The frequency of CD8 T cells among the total (CD3 positive) T cells in PBMC was increased immediately after VTP in both CR and PR. Active, not recruiting --> Completed
- ||| Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial primary completion date: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov) - Dec 20, 2022
P3, N=100, Recruiting, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Completed Trial completion date: Jan 2028 --> Jan 2029 | Trial primary completion date: Jan 2023 --> Feb 2024
- | Tookad (padeliporfin) / ImPact Biotech
Enrollment closed, Enrollment change: A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing (clinicaltrials.gov) - Oct 26, 2022
P1, N=12, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Jan 2028 --> Jan 2029 | Trial primary completion date: Jan 2023 --> Feb 2024 Recruiting --> Active, not recruiting | N=24 --> 12
- || Tookad (padeliporfin) / Steba Biotech
Review, Journal: Emerging photodynamic/sonodynamic therapies for urological cancers: progress and challenges. (Pubmed Central) - Oct 12, 2022
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.
- | Tookad (padeliporfin) / Steba Biotech
Journal: Excimer laser-assisted corneal epithelial pattern ablation for corneal cross-linking. (Pubmed Central) - May 12, 2022
The different safety profile of near-infrared (NIR) may allow safe WST11/NIR CXL even with reduced stromal chromophore concentration values. In vivo studies are needed to evaluate the benefits and further assess safety of excimer laser-assisted patterned de-epithelialization for corneal CXL.
- | Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial primary completion date: A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing (clinicaltrials.gov) - May 5, 2022
P1, N=30, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
In vivo studies are needed to evaluate the benefits and further assess safety of excimer laser-assisted patterned de-epithelialization for corneal CXL. Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2022 --> Apr 2023
- | Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial primary completion date: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - Apr 25, 2022
P1, N=30, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2022 --> Apr 2023 Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
- Tookad (padeliporfin) / Steba Biotech
Final Results of a Phase I Trial of WST11 (TOOKAD Soluble) Vascular-Targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma (Room 252) - Apr 10, 2022 - Abstract #AUA2022AUA_3084;
Conclusions : This clinical trial provides necessary data on light dosing and treatment effects to establish safe treatment conditions with WST-11 VTP for UTUC. An approved Phase 3, multicenter trial with Society of Urologic Oncology-Clinical Trials Consortium support is upcoming.
- || Stakel (padeliporfin) / Steba Biotech, TLD-1433 / Theralase
Clinical, Journal: Clinical Development of Metal Complexes as Photosensitizers for Photodynamic Therapy of Cancer. (Pubmed Central) - Feb 11, 2022
In an effort to overcome these drawbacks, much attention has been devoted towards the incorporation of a metal ion. Herein, the clinical development of metal containing compounds including Purlytin ® , Lutrin ® /Antrin ® , Photosens ® , TOOKAD ® soluble or TLD-1433 is critically reviewed.
- | Stakel (padeliporfin) / Steba Biotech
Preclinical, Journal: Neoadjuvant vascular-targeted photodynamic therapy improves survival and reduces recurrence and progression in a mouse model of urothelial cancer. (Pubmed Central) - Dec 16, 2021
After urothelial tumor implantation and 17 days before surgical resection, mice received neoadjuvant sbVTP (WST11; Tookad Soluble, Steba Biotech, France)...In summary, neoadjuvant sbVTP delayed local and systemic progression, prolonged progression-free and overall survival, and reduced local recurrence, thereby demonstrating therapeutic efficacy through an immune-mediated response. These findings strongly support its evaluation in clinical trials.
- Stakel (padeliporfin) / Steba Biotech
Investigating the multi-modality anti-tumour effects of combined sequential tumour irradiation and vascular-targeted photodynamic therapy in preclinical prostate cancer. ([VIRTUAL]) - Nov 16, 2021 - Abstract #NCRI2021NCRI_278;
We investigated whether sequential delivery of 3x5 Gy FRT followed by VTP (at 7-9 mg/kg WST-11) 7 days later improved tumour control compared to monotherapy with FRT or VTP alone...Further research aims to identify potential mechanisms of co-operation between these two treatments, with the aim of harnessing anti-tumour immunological responses. Impact statement This pre-clinical data provides first proof-of-concept for this multi-modality treatment, and may help to inform the design of future early phase clinical trials.
- ||| Tookad (padeliporfin) / ImPact Biotech
Trial completion date, Trial primary completion date: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov) - Oct 20, 2021
P3, N=100, Recruiting, Sponsor: Steba Biotech S.A.
Impact statement This pre-clinical data provides first proof-of-concept for this multi-modality treatment, and may help to inform the design of future early phase clinical trials. Trial completion date: Jul 2024 --> Jan 2028 | Trial primary completion date: Jul 2022 --> Jan 2023
- Foscan (temoporfin) / American BriVision, Stakel (padeliporfin) / Steba Biotech
[VIRTUAL] Investigation of a novel class of aluminum tris-dipyrrinato complexes as potential photosensitizers (Room: Zoom Room 15) - Aug 13, 2021 - Abstract #ACSFall2021ACS_Fall_6221;
Subsequently, we will focus on the photophysical properties upon photoexcitation and the influence of the metal coordination center. In addition, we intend to investigate the electronic effects of the withdrawing or donating groups to the dipyrrin core; the singlet or triplet intraligant state ability; their emissive properties; and their triplet excited states properties.
- Stakel (padeliporfin) / Steba Biotech
[VIRTUAL] 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 () - Aug 5, 2021 - Abstract #AUA2021AUA_2763;
These positive trial results show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer with minimal toxicity including impact on urinary and sexual function, consistent with the Phase 3 trial results in low-risk disease. Based on these data this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate risk disease.
- Stakel (padeliporfin) / Steba Biotech
[VIRTUAL] Updated Treatment Results from a Phase I study of WST11 Phototherapy (VTP) for Upper Tract Urothelial Carcinoma. () - Aug 5, 2021 - Abstract #AUA2021AUA_2601;
WST11-VTP shows promising evidence of therapeutic treatment effect in low- and high-grade upper tract urothelial tumors with limited treatment related toxicity. These early results provide support for further investigation to evaluate the curative potential for this therapy in a planned multicenter trial.