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- || Stakel (padeliporfin) / Steba Biotech
P2 data, Journal: Medium-term Follow-up of Vascular-targeted Photodynamic Therapy of Localized Prostate Cancer Using TOOKAD Soluble WST-11 (Phase II Trials). (Pubmed Central) - Nov 4, 2020
VTP is a safe and efficient treatment and represents an alternative option for localized low-risk PCa management over the medium term. Precise diagnostic methods and imaging tools are thereby essential requirements to ensure safe and complete targeted therapy.
- | Stakel (padeliporfin) / Steba Biotech
Preclinical, Journal: Enzymatic Digestion of Porcine Corneas Cross-linked by Hypo- and Hyperosmolar Formulations of Riboflavin/ultraviolet A or WST11/Near-Infrared Light. (Pubmed Central) - Sep 23, 2020
Both RF and WST11 based CXL significantly increases resistance to enzymatic digestion, with similar effect for hypo-osmolar and hyperosmolar (dextran enriched) formulations. Our findings indicate these formulations are interchangeable, paving the way for the development of novel PACK-CXL protocols for thin corneas and deep-seated infections.
- | Tookad (padeliporfin) / ImPact Biotech
Enrollment change: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - Aug 19, 2020
P1, N=30, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Our findings indicate these formulations are interchangeable, paving the way for the development of novel PACK-CXL protocols for thin corneas and deep-seated infections. N=18 --> 30
- | Stakel (padeliporfin) / Steba Biotech
Preclinical, Journal: Effectiveness of the combination of vascular targeted photodynamic therapy and anti-cytotoxic T-lymphocyte-associated antigen 4 in a preclinical mouse model of urothelial carcinoma. (Pubmed Central) - Jun 18, 2020
Combination of vascular targeted photodynamic therapy with anti-cytotoxic T-lymphocyte-associated antigen 4 is an effective therapy in a urothelial carcinoma syngeneic mouse model. The present results suggest this therapy as a potential treatment option for both bladder and upper tract tumors in future clinical trials.
- || Stakel (padeliporfin) / Steba Biotech
Review, Journal: Photodynamic diagnosis and therapy for urothelial carcinoma and prostate cancer: new imaging technology and therapy. (Pubmed Central) - May 27, 2020
Vascular-activated photosensitizer induces rapid tumor ablation by PDT involving direct tumor cell killing as well as damage to the exposed microvasculature. We summarize the clinical outcomes of PDD and PDT for urothelial carcinoma and prostate cancer.
- Stakel (padeliporfin) / Steba Biotech
[VIRTUAL] Interim Results: A Phase 2b Trial of Padeliporfin (WST11) Vascular-Targeted Photodynamic Therapy as Partial-Gland Ablation for Men with Intermediate-Risk Prostate Cancer () - May 17, 2020 - Abstract #AUA2020AUA_3359;
Full data for the primary endpoint are anticipated by November 2020. Source of Funding: Steba Biotech, Sidney Kimmel Center for Prostate and Urologic Cancers, NIH/NCI Cancer Center Support Grant P30 CA008748, Thompson Family Foundation
- paclitaxel / Generic mfg., Stakel (padeliporfin) / Steba Biotech
[VIRTUAL] A NOVEL P-SELECTIN TARGET NANOPARTICLES CHEMOTHERAPY DELIVERY COMBINED WITH WST-11 VASCULAR TARGET PHOTODYNAMIC THERAPY (TOOKAD-VTP) TO IMPROVE LOCAL TUMOR CONTROL IN A PROSTATE CANCER MODEL (WEWCC: 146C) - May 17, 2020 - Abstract #AUA2020AUA_2072;
P-selectin target nanoparticles chemotherapy combined with VTP ablation is a promising approach to improve local tumor control and decrease tumor relapses in a prostate cancer model. A single dose administration and the high intra-tumor concentration seems to be effective and potentially decreases the risk of chemotherapy side effects. Source of Funding: Tomphson Family Foundation
- | 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 3, 2020
P1, N=30, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Source of Funding: Tomphson Family Foundation Trial completion date: Apr 2020 --> Apr 2021 | Trial primary completion date: Apr 2020 --> Apr 2021
- | 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) - Feb 25, 2020
P1, N=18, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Apr 2020 --> Apr 2021 | Trial primary completion date: Apr 2020 --> Apr 2021 Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2020 --> Aug 2021
- | Tookad (padeliporfin) / Steba Biotech
New P3 trial: Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer (clinicaltrials.gov) - Jan 13, 2020
P3, N=400, Not yet recruiting, Sponsor: Steba Biotech S.A.
- | Tookad (padeliporfin) / Steba Biotech
Enrollment closed, Trial completion date, HEOR: CLIN1601 PCM204t: Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. (clinicaltrials.gov) - Dec 24, 2019
P2, N=50, Active, not recruiting, Sponsor: Steba Biotech S.A.
Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2020 --> Aug 2021 Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Oct 2024
- || Firmagon (degarelix) / Astellas, Ferring, Stakel (padeliporfin) / Steba Biotech
Clinical, Journal: Androgen Deprivation Therapy Potentiates the Efficacy of Vascular Targeted Photodynamic Therapy of Prostate Cancer Xenografts. (Pubmed Central) - Dec 24, 2019
Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Oct 2024 Improvement of local tumor control following androgen deprivation combined with VTP provides the rationale and preliminary protocol parameters for clinical trials in patients presented with locally advanced PCa.
- || Stakel (padeliporfin) / Steba Biotech, TLD1433 / Theralase
Review, Journal: Metal-based photosensitizers for photodynamic therapy: the future of multimodal oncology? (Pubmed Central) - Nov 24, 2019
This short review surveys two recent clinical examples of metal complexes, namely TOOKAD®-Soluble and TLD-1433, which have ideal photophysical properties to act as PDT PSs. We highlight the important role played by the metal ions in the PS for PDT activity.
- | Stakel (padeliporfin) / Steba Biotech
Clinical, Journal: Expanding indication of padeliporfin (WST11) vascular-targeted photodynamic therapy: results of prostate cancer Latin-American multicenter study. (Pubmed Central) - Sep 22, 2019
We highlight the important role played by the metal ions in the PS for PDT activity. Results support the efficacy, safety, and QoL associated with padeliporfin focal treatment for low/intermediate risk localized PCa.
- | Stakel (padeliporfin) / Steba Biotech
Journal: Sphingosinithalassobacter portus gen. nov., sp. nov., a novel member of the family Sphingomonadaceae isolated from surface seawater. (Pubmed Central) - Sep 12, 2019
...Phylogenetic analysis based on 16S rRNA gene sequences indicated that strain FM6 belonged to the family Sphingomonadaceae and was closely related to species of the genera Sphingomonas (96.3 %) and Stakelama (96.0 %)...nov. is FM6 (=MCCC 1K03501=JCM 32714).
- ||| Stakel (padeliporfin) / Steba Biotech
Parcour 2019 bekend. Worden 21 #keiharde kilometers. #smr #smr2019 #Hellendoorn #obstakels #dontcryjustrun #running #4weeks (Twitter) - Aug 2, 2019
- | Stakel (padeliporfin) / Steba Biotech
Journal, PD(L)-1 Biomarker, IO biomarker: Systemic antitumor immunity by PD-1/PD-L1 inhibition is potentiated by vascular-targeted photodynamic therapy of primary tumors. (Pubmed Central) - Jul 26, 2019
Our results demonstrate a role for local immune modulation with VTP in combination with PD-1/PD-L1 pathway inhibition for generation of potent local and systemic antitumor responses. This combined-modality strategy may be an effective therapy in cancers resistant to PD-1/PD-L1 pathway inhibition alone.
- | Stakel (padeliporfin) / Steba Biotech
Preclinical, Journal: Potentiating vascular-targeted photodynamic therapy through CSF-1R modulation of myeloid cells in a preclinical model of prostate cancer. (Pubmed Central) - May 10, 2019
Importantly, we found that targeting myeloid cells using anti-CSF1R in combination with VTP therapy decreased the number of tumor MDSCs and TAMs, especially M2 macrophages, as well as increased CD8 T cell infiltration, decreased tumor growth and improved overall survival. These results suggest that targeting myeloid cells via CSF1R targeting is a promising strategy to potentiate the anti-tumor effects of VTP.
- | 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 3, 2019
P1, N=36, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
These results suggest that targeting myeloid cells via CSF1R targeting is a promising strategy to potentiate the anti-tumor effects of VTP. Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2019 --> Apr 2020
- | Tookad (padeliporfin) / Steba Biotech
Trial completion date, Trial primary completion date, HEOR: CLIN1601 PCM204t: Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. (clinicaltrials.gov) - Jan 28, 2019
P2, N=50, Recruiting, Sponsor: Steba Biotech S.A.
Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2019 --> Apr 2020 Trial completion date: Mar 2024 --> Dec 2025 | Trial primary completion date: Mar 2019 --> Dec 2020
- | Stakel (padeliporfin) / Steba Biotech
Preclinical, Journal: WST11 Vascular Targeted Photodynamic Therapy Effect Monitoring by Multispectral Optoacoustic Tomography (MSOT) in Mice. (Pubmed Central) - Dec 14, 2018
Handheld MSOT non-invasively monitored WST11-VTP effects based on the SO2 signal and detected blood saturation changes within the first 20 min post-treatment. MSOT may potentially serve as a means for both VTP induction and real-time VTP monitoring in a theranostic approach.
- | Stakel (padeliporfin) / Steba Biotech
Journal: Treatment Effects of WST11 Vascular Targeted Photodynamic Therapy in Urothelial Cell Carcinoma and Feasibility, Safety, and Long Term Outcomes in the Upper Urinary Tract of Swine. (Pubmed Central) - Aug 12, 2018
Depth of WST11 vascular-targeted photodynamic therapy treatment effects can be modulated in a dose-dependent manner by titration of light intensity. Moreover, this treatment modality, applied to the porcine upper urinary tract, is feasible via antegrade and retrograde access.
- | Stakel (padeliporfin) / Steba Biotech
Preclinical, Journal: Contrast enhanced ultrasound imaging can predict vascular-targeted photodynamic therapy induced tumor necrosis in small animals. (Pubmed Central) - Aug 12, 2018
Moreover, this treatment modality, applied to the porcine upper urinary tract, is feasible via antegrade and retrograde access. CEUS allows accurate monitoring of VTP induced tumor necrosis in a small animal model.
- | Stakel (padeliporfin) / Steba Biotech
Clinical, P1/2 data, Journal: Final Results of a Phase I/II Multicenter Trial of WST11 (TOOKAD® Soluble) Vascular-Targeted Photodynamic Therapy (VTP) for Hemiablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Conducted in the United States. (Pubmed Central) - Aug 8, 2018
Dosing parameters and the light dose index appear related to tissue response as determined by magnetic resonance imaging and biopsy. These parameters may serve as the basis for further prospective studies.
- | Tookad (padeliporfin) / ImPact Biotech
New P1 trial: Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - Aug 6, 2018
P1, N=18, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- | Stakel (padeliporfin) / Steba Biotech
Journal: Bombesin Antagonist Based Radiotherapy of Prostate Cancer Combined with WST-11 Vascular Targeted Photodynamic Therapy. (Pubmed Central) - May 4, 2018
These parameters may serve as the basis for further prospective studies. Tumor vascular arrest by VTP improves 90Y-DOTA-AR retention in the tumor microenvironment thereby enhancing therapeutic efficacy.
- | Tookad (padeliporfin) / ImPact Biotech
Enrollment change: Vascular Targeted Photodynamic Therapy T1a Renal Tumours (clinicaltrials.gov) - Jan 10, 2018
P2a, N=5, Terminated, Sponsor: University of Oxford
Tumor vascular arrest by VTP improves 90Y-DOTA-AR retention in the tumor microenvironment thereby enhancing therapeutic efficacy. N=12 --> 5
- | Stakel (padeliporfin) / Steba Biotech
Journal: Transurethral Photoacoustic Endoscopy for Prostate Cancer: A Simulation Study. (Pubmed Central) - Dec 17, 2017
The sensitivity of the photoacoustic detection for TOOKAD was 0.18ng/mg at a 763 nm laser wavelength. Results of this study will greatly enhance the potential of prostate PAE for in vivo monitoring of drug delivery and guidance of the laser-induced therapy for future clinical use.
- | Tookad (padeliporfin) / Steba Biotech
New P2 trial, HEOR: CLIN1601 PCM204t: Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. (clinicaltrials.gov) - Oct 20, 2017
P2, N=50, Recruiting, Sponsor: Steba Biotech S.A.
- | Tookad (padeliporfin) / ImPact Biotech
New P1 trial: 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) - Apr 27, 2017
P1, N=36, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- | Tookad (padeliporfin) / Steba Biotech
Trial completion: Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (clinicaltrials.gov) - Nov 9, 2015
P3, N=413, Completed, Sponsor: Steba Biotech S.A.
Results of this study will greatly enhance the potential of prostate PAE for in vivo monitoring of drug delivery and guidance of the laser-induced therapy for future clinical use. Active, not recruiting --> Completed
- Tookad (padeliporfin) / Steba Biotech
Enrollment change, Trial termination, Trial primary completion date: Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD (clinicaltrials.gov) - Apr 29, 2015
P2a, N=11, Terminated, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Completed N=18 --> 11 | Suspended --> Terminated | Trial primary completion date: Sep 2013 --> May 2012; Retinal vascular occlusion in 2 patients
- | Tookad (padeliporfin) / Steba Biotech
Trial completion, Trial primary completion date, HEOR: Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (clinicaltrials.gov) - Apr 28, 2015
P3, N=81, Completed, Sponsor: Steba Biotech S.A.
N=18 --> 11 | Suspended --> Terminated | Trial primary completion date: Sep 2013 --> May 2012; Retinal vascular occlusion in 2 patients Active, not recruiting --> Completed | Trial primary completion date: Jul 2014 --> Dec 2014
- | Tookad (padeliporfin) / Steba Biotech
Enrollment closed, HEOR: Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (clinicaltrials.gov) - Jul 1, 2014
P3, N=81, Active, not recruiting, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Completed | Trial primary completion date: Jul 2014 --> Dec 2014 Recruiting --> Active, not recruiting
- Tookad (padeliporfin) / ImPact Biotech
Trial initiation date: Vascular Targeted Photodynamic Therapy T1a Renal Tumours (clinicaltrials.gov) - Jun 30, 2013
P2a, N=12, Recruiting, Sponsor: University of Oxford
Recruiting --> Active, not recruiting Initiation date: May 2012 --> May 2013
- Tookad (padeliporfin) / ImPact Biotech
Enrollment open: Vascular Targeted Photodynamic Therapy T1a Renal Tumours (clinicaltrials.gov) - Jun 30, 2013
P2a, N=12, Recruiting, Sponsor: University of Oxford
Initiation date: May 2012 --> May 2013 Not yet recruiting --> Recruiting
- | Tookad (padeliporfin) / Steba Biotech
Enrollment closed: Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (clinicaltrials.gov) - Jun 18, 2013
P3, N=413, Active, not recruiting, Sponsor: Steba Biotech S.A.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || Tookad (padeliporfin) / Steba Biotech
New P3 trial, HEOR: Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (clinicaltrials.gov) - Jun 9, 2013
P3, N=80, Recruiting, Sponsor: Steba Biotech S.A.
- Tookad (padeliporfin) / Steba Biotech
Trial completion: Study Using WST11 in Patients With Localized Prostate Cancer (clinicaltrials.gov) - Sep 13, 2012
P2, N=86, Completed, Sponsor: Steba Biotech S.A.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- Tookad (padeliporfin) / Steba Biotech
Trial completion: Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer (clinicaltrials.gov) - Sep 13, 2012
P1/2, N=30, Completed, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Tookad (padeliporfin) / Steba Biotech
Trial completion: Study of WST11 in Patients With Localized Prostate Cancer (clinicaltrials.gov) - Jul 3, 2012
P2, N=40, Completed, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Tookad (padeliporfin) / ImPact Biotech
New P2a trial: Vascular Targeted Photodynamic Therapy T1a Renal Tumours (clinicaltrials.gov) - Apr 4, 2012
P2a, N=12, Recruiting, Sponsor: University of Oxford
- Tookad (padeliporfin) / Steba Biotech
Trial termination: Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 3, 2012
P2, N=3, Terminated, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Completed Active, not recruiting --> Terminated; Early end of enrolment with regards to difficulty met to enrol patients.
- Tookad (padeliporfin) / Steba Biotech
Trial suspension: Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD (clinicaltrials.gov) - Jan 3, 2012
P2a, N=18, Suspended, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Terminated; Early end of enrolment with regards to difficulty met to enrol patients. Recruiting --> Suspended
- Tookad (padeliporfin) / Steba Biotech
Enrollment change: Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 3, 2012
P2, N=3, Terminated, Sponsor: Steba Biotech S.A.
Recruiting --> Suspended N=18 --> 3
- Tookad (padeliporfin) / Steba Biotech
Trial termination: Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma (clinicaltrials.gov) - Jan 3, 2012
P2, N=7, Terminated, Sponsor: Steba Biotech S.A.
N=18 --> 3 Active, not recruiting --> Terminated; Early end of enrolment with regards to difficulty met to enrol patients .
- Tookad (padeliporfin) / Steba Biotech
Enrollment change: Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma (clinicaltrials.gov) - Jan 3, 2012
P2, N=7, Terminated, Sponsor: Steba Biotech S.A.
Active, not recruiting --> Terminated; Early end of enrolment with regards to difficulty met to enrol patients . N=12 --> 7