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4 Products |  |
0 Diseases | | 4 Products |
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5 Trials |  |
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- || dusquetide (SGX942) / Soligenix
Enrollment open, Trial initiation date: Dusquetide for the Treatment of Behcet's Disease (clinicaltrials.gov) - Nov 17, 2024
P2, N=25, Recruiting, Sponsor: Soligenix
Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Nov 2024
- HyBryte (synthetic hypericin) / Soligenix
Trial completion: HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL (clinicaltrials.gov) - Jul 3, 2024
P2, N=10, Completed, Sponsor: Soligenix
Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Nov 2024 Recruiting --> Completed
- |||||||| HyBryte (synthetic hypericin) / Soligenix
New P3 trial: FLASH2: Confirmatory Study of Topical HyBryte (clinicaltrials.gov) - Jun 24, 2024
P3, N=80, Not yet recruiting, Sponsor: Soligenix
- ||| Kepivance (palifermin) / SOBI, Amgen, avasopasem manganese (GC4419) / Galera Therap, dusquetide (SGX942) / Soligenix
Clinical, P3 data, Journal: Comparisons of successful and failed Phase III trials of drugs and biologicals tested for mitigation of oral mucositis in patients being treated with radiotherapy with or without concomitant chemotherapy for cancers of the head and neck. (Pubmed Central) - Apr 28, 2024
We found that differences in the level of sponsor funding, patient inclusion criteria including radiation source and concomitant chemotherapy regimen, and concordance of primary efficacy outcomes between Phase II and Phase III trials influenced outcomes. To properly design clinical trials for OM in HNC patients, it is important that researchers and sponsors take note of specific study characteristics associated with success or failure, particularly with Phase III trials where the risks and costs are the highest.
- || dusquetide (SGX942) / Soligenix
New P2 trial: Dusquetide for the Treatment of Behcet's Disease (clinicaltrials.gov) - Apr 26, 2024
P2, N=25, Not yet recruiting, Sponsor: Soligenix
- | synthetic hypericin (SGX302) / Soligenix
Trial completion date, Trial primary completion date: Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - Apr 23, 2024
P2, N=42, Recruiting, Sponsor: Soligenix
To properly design clinical trials for OM in HNC patients, it is important that researchers and sponsors take note of specific study characteristics associated with success or failure, particularly with Phase III trials where the risks and costs are the highest. Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Oct 2023 --> Apr 2025
- HyBryte (synthetic hypericin) / Soligenix
Enrollment open: HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL (clinicaltrials.gov) - Dec 7, 2023
P2, N=10, Recruiting, Sponsor: Soligenix
Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Oct 2023 --> Apr 2025 Not yet recruiting --> Recruiting
- HyBryte (synthetic hypericin) / Soligenix
New P2 trial: HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL (clinicaltrials.gov) - Nov 27, 2023
P2, N=10, Not yet recruiting, Sponsor: Soligenix
- || HyBryte (synthetic hypericin) / Soligenix
Enrollment open: RW-HPN-MF-01: Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light (clinicaltrials.gov) - Oct 30, 2023
P2, N=50, Recruiting, Sponsor: Ellen Kim, MD
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || HyBryte (synthetic hypericin) / Soligenix
New P2 trial: RW-HPN-MF-01: Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light (clinicaltrials.gov) - May 24, 2023
P2, N=50, Not yet recruiting, Sponsor: Ellen Kim, MD
- | dusquetide (SGX942) / Soligenix
Journal: Linker-Free Synthesis of Antimicrobial Peptides Using a Novel Cleavage Reagent: Characterisation of the Molecular and Ionic Composition by nanoESI-HR MS. (Pubmed Central) - Apr 28, 2023
The novel methodology was successful in synthesising three antimicrobial peptides, including the cyclic compound polymyxin B3, dusquetide, and RR4 heptapeptide. Furthermore, electrospray mass spectrometry (ESI-MS) is successfully used for the full characterisation of both the molecular and ionic composition of the synthetic peptides.
- | dusquetide (SGX942) / Soligenix
Journal: Protocol to identify drug-binding sites in proteins using solution NMR spectroscopy. (Pubmed Central) - Jan 4, 2023
Dusquetide is a next-generation IDR (innate defense regulator) targeting the major autophagy receptor protein SQSTM1/p62 and modulating the innate immune response...For complete details on the use and execution of this protocol, please refer to Zhang et al. (2022).
- ||| synthetic hypericin (SGX302) / Soligenix
Enrollment open, Enrollment change: Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - Dec 19, 2022
P2, N=42, Recruiting, Sponsor: Soligenix
(2022). Not yet recruiting --> Recruiting | N=32 --> 42
- ||| HyBryte (synthetic hypericin) / Soligenix
Clinical, P3 data, Journal: Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. (Pubmed Central) - Sep 24, 2022
P3
The findings of this randomized clinical trial indicate that synthetic hypericin PDT is effective in early-stage patch and plaque MF/CTCL and has a favorable safety profile. ClinicalTrials.gov Identifier: NCT02448381.
- ||||||| dusquetide (SGX942) / Soligenix
Trial completion: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer (clinicaltrials.gov) - Aug 29, 2022
P3, N=266, Completed, Sponsor: Soligenix
ClinicalTrials.gov Identifier: NCT02448381. Active, not recruiting --> Completed
- HyBryte (synthetic hypericin) / Soligenix
Trial completion: PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma (clinicaltrials.gov) - Aug 25, 2022
P2a, N=9, Completed, Sponsor: Soligenix
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | dusquetide (SGX942) / Soligenix
Journal: Dusquetide modulates innate immune response through binding to p62. (Pubmed Central) - Aug 11, 2022
Dusquetide binding modulates the p62-RIP1 complex, increases p38 phosphorylation, and enhances CEBP/B expression without activating autophagy. Our findings provide molecular details underlying the IDR action that may help in the development of new strategies to pharmacologically target p62.
- HyBryte (synthetic hypericin) / Soligenix
Enrollment closed: PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma (clinicaltrials.gov) - Jul 1, 2022
P2a, N=9, Active, not recruiting, Sponsor: Soligenix
Our findings provide molecular details underlying the IDR action that may help in the development of new strategies to pharmacologically target p62. Recruiting --> Active, not recruiting
- || synthetic hypericin (SGX302) / Soligenix
New P2 trial: Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - Jul 1, 2022
P2, N=32, Not yet recruiting, Sponsor: Soligenix
- | dusquetide (SGX942) / Soligenix
$SNGX Key Binding Characteristics of Dusquetide to Important Intracellular Protein Identified https://t.co/jqqLcBTizZ (Twitter) - Jun 1, 2022
- HyBryte (synthetic hypericin) / Soligenix
New P2a trial: PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma (clinicaltrials.gov) - May 18, 2022
P2a, N=6, Recruiting, Sponsor: Soligenix
- ||||| HyBryte (synthetic hypericin) / Soligenix
Trial completion: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - Jan 11, 2022
P3, N=169, Completed, Sponsor: Soligenix
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||| HyBryte (synthetic hypericin) / Soligenix
Clinical: $SNGX Soligenix Granted Pediatric Investigational Plan Waiver for HyBryte™ in CTCL in the United Kingdom https://t.co/CeniKPwlN8 (Twitter) - Nov 8, 2021
- || HyBryte (synthetic hypericin) / Soligenix
$SNGX HyBryte™ FLASH Study Selected as a 'Top Poster' Winner for Presentation at the National Organization for Rare Disorders' Rare Diseases and Orphan Products Breakthrough Summit https://t.co/rviAkF4rNs (Twitter) - Oct 12, 2021
- ||| HyBryte (synthetic hypericin) / Soligenix
$SNGX Soligenix to Advance Synthetic Hypericin Development in Psoriasis https://t.co/1Fmncfbuac (Twitter) - Sep 16, 2021
- || HyBryte (synthetic hypericin) / Soligenix
NDA: $SNGX ↓ 22% PM. NDA submission for SGX301 pushed to 1H'22. (Twitter) - May 10, 2021
- |||| synthetic hypericin (SGX301) / Soligenix
FDA event: $SNGX Soligenix Receives Conditional FDA Acceptance of Proposed Brand Name HyBryte™ for SGX301 in CTCL https://t.co/ezlAuY23g1 (Twitter) - Apr 7, 2021
- ||| synthetic hypericin (SGX301) / Soligenix
FDA event: $SNGX Soligenix is Ready for Commercialization of SGX301 (HyBryte(TM)); FDA Has Approval Process on Fast Track https://t.co/DmBODwHeJo (Twitter) - Feb 23, 2021
- HyBryte (synthetic hypericin) / Soligenix
[VIRTUAL] Topical hypericin ointment photodynamic therapy is effective and safe in CTCL (FLASH study) () - Feb 12, 2021 - Abstract #SID2021SID_420;
No drug-related serious AEs occurred and SGX310 was not found systemically. SGX301 is effective in early stage CTCL with a highly favorable safety profile.
- orBec (beclomethasone dipropionate oral) / Soligenix
[VIRTUAL] IMPACT OF UPPER AND LOWER ACUTE GASTROINTESTINAL GRAFT-VERSUS-HOST DISEASE ON GRADING AND OUTCOME OF ALLOGENEIC STEM CELL TRANSPLANTATION: A RETROSPECTIVE ANALYSIS IN 122 CONSECUTIVE PATIENTS (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_3298;
GI aGVHD remains an important obstacle to the success of allo-HSCT, in particularly lower GI aGVHD represents a potentially fatal complication of allo-HSCT. Upper GI aGVHD presents a minor impact on survival and patients with aGVHD classified as grade 2A have similar outcome as those with lower grade aGVHD.
- orBec (beclomethasone dipropionate oral) / Soligenix
[VIRTUAL] IMPACT OF UPPER AND LOWER ACUTE GASTROINTESTINAL GRAFT-VERSUS-HOST DISEASE ON GRADING AND OUTCOME OF ALLOGENEIC STEM CELL TRANSPLANTATION: A RETROSPECTIVE ANALYSIS IN 122 CONSECUTIVE PATIENTS (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_3297;
GI aGVHD remains an important obstacle to the success of allo-HSCT, in particularly lower GI aGVHD represents a potentially fatal complication of allo-HSCT. Upper GI aGVHD presents a minor impact on survival and patients with aGVHD classified as grade 2A have similar outcome as those with lower grade aGVHD.
- orBec (beclomethasone dipropionate oral) / Soligenix
[VIRTUAL] IMPACT OF UPPER AND LOWER ACUTE GASTROINTESTINAL GRAFT-VERSUS-HOST DISEASE ON GRADING AND OUTCOME OF ALLOGENEIC STEM CELL TRANSPLANTATION: A RETROSPECTIVE ANALYSIS IN 122 CONSECUTIVE PATIENTS (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_3296;
GI aGVHD remains an important obstacle to the success of allo-HSCT, in particularly lower GI aGVHD represents a potentially fatal complication of allo-HSCT. Upper GI aGVHD presents a minor impact on survival and patients with aGVHD classified as grade 2A have similar outcome as those with lower grade aGVHD.
- ||||| dusquetide (SGX942) / Soligenix
Enrollment closed: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer (clinicaltrials.gov) - Jul 1, 2020
P3, N=268, Active, not recruiting, Sponsor: Soligenix
Upper GI aGVHD presents a minor impact on survival and patients with aGVHD classified as grade 2A have similar outcome as those with lower grade aGVHD. Recruiting --> Active, not recruiting
- | Journal: Efonidipine-Induced Exanthematic Drug Eruption and Literature Review. (Pubmed Central) - May 19, 2020
Her presenting complaints were initially managed with parenteral pheniramine maleate and hydrocortisone...She was prescribed topical beclomethasone and oral antihistamines for better control of her symptoms...World Health Organization-Uppsala Monitoring Centre causality assessment criteria indicated a "certain" association. To the best of the knowledge of the authors, this is one among the first reported cases of efonidipine-induced exanthematic drug eruption.
- orBec (beclomethasone dipropionate oral) / Soligenix
[VIRTUAL] IMPACT OF UPPER AND LOWER ACUTE GASTROINTESTINAL GRAFT-VERSUS-HOST DISEASE ON GRADING AND OUTCOME OF ALLOGENEIC STEM CELL TRANSPLANTATION: A RETROSPECTIVE ANALYSIS IN 122 CONSECUTIVE PATIENTS (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_1213;
GI aGVHD remains an important obstacle to the success of allo-HSCT, in particularly lower GI aGVHD represents a potentially fatal complication of allo-HSCT. Upper GI aGVHD presents a minor impact on survival and patients with aGVHD classified as grade 2A have similar outcome as those with lower grade aGVHD.
- ||| dusquetide (SGX942) / Soligenix
#Soligenix Announces Japanese Patent Allowance for Use of #Dusquetide in #OralMucositis $SNGX https://t.co/Svvpa5Fnsn (Twitter) - Feb 4, 2020
- |||| HyBryte (synthetic hypericin) / Soligenix
Enrollment closed: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - Dec 4, 2019
P3, N=169, Active, not recruiting, Sponsor: Soligenix
Upper GI aGVHD presents a minor impact on survival and patients with aGVHD classified as grade 2A have similar outcome as those with lower grade aGVHD. Recruiting --> Active, not recruiting
- ||||| dusquetide (SGX942) / Soligenix
Enrollment change, Trial completion date, Trial primary completion date: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer (clinicaltrials.gov) - Nov 3, 2019
P3, N=260, Recruiting, Sponsor: Soligenix
Recruiting --> Active, not recruiting N=190 --> 260 | Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Jun 2020
- ||| dusquetide (SGX942) / Soligenix
Trial completion date, Trial primary completion date: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer (clinicaltrials.gov) - Apr 23, 2019
P3, N=190, Recruiting, Sponsor: Soligenix
N=190 --> 260 | Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Jun 2020 Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Mar 2019 --> Mar 2020
- ||||| HyBryte (synthetic hypericin) / Soligenix
Enrollment change, Trial primary completion date: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - Oct 23, 2018
P3, N=160, Recruiting, Sponsor: Soligenix
Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Mar 2019 --> Mar 2020 N=120 --> 160 | Trial primary completion date: Dec 2018 --> Dec 2019
- |||| HyBryte (synthetic hypericin) / Soligenix
Trial primary completion date: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - Apr 23, 2018
P3, N=120, Recruiting, Sponsor: Soligenix
N=120 --> 160 | Trial primary completion date: Dec 2018 --> Dec 2019 Trial primary completion date: Dec 2017 --> Dec 2018
- |||||||||| dusquetide (SGX942) / Soligenix
New P3 trial: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer (clinicaltrials.gov) - Aug 1, 2017
P3, N=190, Recruiting, Sponsor: Soligenix
- |||| dusquetide (SGX942) / Soligenix
Trial completion, Enrollment change: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Jul 31, 2017
P2, N=111, Completed, Sponsor: Soligenix
Trial primary completion date: Dec 2017 --> Dec 2018 Active, not recruiting --> Completed | N=78 --> 111
- |||| HyBryte (synthetic hypericin) / Soligenix
Trial primary completion date: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - Mar 23, 2017
P3, N=120, Recruiting, Sponsor: Soligenix
Active, not recruiting --> Completed | N=78 --> 111 Trial primary completion date: Dec 2016 --> Dec 2017
- |||||| HyBryte (synthetic hypericin) / Soligenix
Enrollment open, Trial initiation date: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - Dec 14, 2015
P3, N=120, Recruiting, Sponsor: Soligenix
Trial primary completion date: Dec 2016 --> Dec 2017 Not yet recruiting --> Recruiting | Initiation date: Jun 2015 --> Dec 2015
- ||| dusquetide (SGX942) / Soligenix
Enrollment closed: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Sep 22, 2015
P2, N=78, Active, not recruiting, Sponsor: Soligenix
Not yet recruiting --> Recruiting | Initiation date: Jun 2015 --> Dec 2015 Recruiting --> Active, not recruiting
- || dusquetide (SGX942) / Soligenix
Trial primary completion date: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Jun 11, 2015
P2, N=78, Recruiting, Sponsor: Soligenix
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2014 --> Oct 2015
- orBec (beclomethasone dipropionate oral) / Soligenix
Enrollment change, Trial termination, Monotherapy: Study of orBec (clinicaltrials.gov) - Jun 11, 2015
P2, N=2, Terminated, Sponsor: Soligenix
Trial primary completion date: Dec 2014 --> Oct 2015 N=40 --> 2 | Recruiting --> Terminated; The study was stopped due to patient enrollment challenges.
- |||||||||| HyBryte (synthetic hypericin) / Soligenix
New P3 trial: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (clinicaltrials.gov) - May 19, 2015
P3, N=135, Not yet recruiting, Sponsor: Soligenix
- |||| dusquetide (SGX942) / Soligenix
Enrollment open: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Jan 6, 2014
P2, N=78, Recruiting, Sponsor: Soligenix
N=40 --> 2 | Recruiting --> Terminated; The study was stopped due to patient enrollment challenges. Active, not recruiting --> Recruiting