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Artikel ; Online: KEYNOTE - D36: personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma.

Long, Georgina V / Ferrucci, Pier Francesco / Khattak, Adnan / Meniawy, Tarek M / Ott, Patrick Alexander / Chisamore, Michael / Trolle, Thomas / Hyseni, Agon / Heegaard, Erik

Future oncology (London, England)

2022 Band 18, Heft 31, Seite(n) 3473–3480

Abstract: Despite improvements made with checkpoint inhibitor (CPI) therapy, a need for new approaches to improve outcomes for patients with unresectable or metastatic melanoma remains. EVX-01, a personalized neoepitope vaccine, combined with pembrolizumab ... ...

Abstract	Despite improvements made with checkpoint inhibitor (CPI) therapy, a need for new approaches to improve outcomes for patients with unresectable or metastatic melanoma remains. EVX-01, a personalized neoepitope vaccine, combined with pembrolizumab treatment, holds the potential to fulfill this need. Here we present the rationale and novel design behind the KEYNOTE - D36 trial: an open label, single arm, phase II trial aiming to establish the clinical proof of concept and evaluate the safety of EVX-01 in combination with pembrolizumab in CPI naive patients with unresectable or metastatic melanoma. The primary objective is to evaluate if EVX-01 improves best overall response after initial stable disease or partial response to pembrolizumab treatment, in patients with advanced melanoma. The novel end points ensure a decisive readout which may prove helpful before making major investments in phase III trials with limited phase I data.
Mesh-Begriff(e)	Humans ; Melanoma/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Immunotherapy ; Vaccines/therapeutic use
Chemische Substanzen	pembrolizumab (DPT0O3T46P) ; Antibodies, Monoclonal, Humanized ; Vaccines
Sprache	Englisch
Erscheinungsdatum	2022-09-01
Erscheinungsland	England
Dokumenttyp	Journal Article ; Clinical Trial Protocol
ZDB-ID	2274956-1
ISSN	1744-8301 ; 1479-6694
ISSN (online)	1744-8301
ISSN	1479-6694
DOI	10.2217/fon-2022-0694
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).

Klonoff, David C / Evans, Mark L / Lane, Wendy / Kempe, Hans-Peter / Renard, Eric / DeVries, J Hans / Graungaard, Tina / Hyseni, Agon / Gondolf, Theis / Battelino, Tadej

Diabetes, obesity & metabolism

2019 Band 21, Heft 4, Seite(n) 961–967

Abstract: Aim: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D).: Materials and methods: This was a ... ...

Abstract	Aim: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D). Materials and methods: This was a double-blind, treat-to-target, randomized, 16-week trial investigating CSII treatment with faster aspart (n = 236) or IAsp (n = 236). All available information, regardless of treatment discontinuation, was used for the evaluation of effect. Results: Faster aspart was non-inferior to IAsp regarding the change from baseline in glycated haemoglobin (HbA1c; primary endpoint). The mean HbA1c changed from 58.4 mmol/mol (7.5%) at baseline to 57.8 mmol/mol (7.4%) with faster aspart and to 56.8 mmol/mol (7.4%) with IAsp after 16 weeks' treatment, with an estimated treatment difference (ETD) of 1.0 mmol/mol (95% confidence interval [CI] 0.14; 1.87) or 0.09% (95% CI 0.01; 0.17; P < 0.001) for non-inferiority (0.4% margin; P < 0.02 for statistical significance in favour of IAsp). Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/dL [95% CI -25.7; -7.0]; P = 0.001), with statistically significant reductions also at 30 minutes and 2 hours. The improvement in PPG was reflected in the change from baseline in 1-hour interstitial glucose increment after all meals (ETD -0.21 mmol/L [95% CI -0.31; -0.11] or -3.77 mg/dL [95% CI -5.53; -2.01]). There was no statistically significant difference in the overall rate of severe or blood glucose-confirmed hypoglycaemia (estimated rate ratio 1.00 [95% CI 0.85; 1.16]). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and 4-week run-in periods (4 vs 0). Conclusions: Faster aspart provides an effective and safe option for CSII treatment in T1D.
Mesh-Begriff(e)	Adult ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/metabolism ; Dosage Forms ; Double-Blind Method ; Excipients ; Female ; Glycated Hemoglobin A/metabolism ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemic Agents/therapeutic use ; Infusions, Subcutaneous ; Insulin Aspart/therapeutic use ; Insulin Infusion Systems ; Male ; Middle Aged
Chemische Substanzen	Dosage Forms ; Excipients ; Glycated Hemoglobin A ; Hypoglycemic Agents ; hemoglobin A1c protein, human ; Insulin Aspart (D933668QVX)
Sprache	Englisch
Erscheinungsdatum	2019-01-13
Erscheinungsland	England
Dokumenttyp	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.13610
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Active von Willebrand factor predicts 28-day mortality in patients with systemic inflammatory response syndrome.

Hyseni, Agon / Kemperman, Hans / de Lange, Dylan W / Kesecioglu, Jozef / de Groot, Philip G / Roest, Mark

Blood

2014 Band 123, Heft 14, Seite(n) 2153–2156

Abstract: Endothelial dysfunction contributes to the pathology of systemic inflammatory response syndrome (SIRS). However, endothelial biomarkers are not routinely evaluated in this setting. Here, 275 patients with SIRS and plasma levels of von Willebrand factor ( ... ...

Abstract	Endothelial dysfunction contributes to the pathology of systemic inflammatory response syndrome (SIRS). However, endothelial biomarkers are not routinely evaluated in this setting. Here, 275 patients with SIRS and plasma levels of von Willebrand factor (VWF), thrombospondin-1, myeloperoxidase, ADAMTS-13, and active VWF (aVWF) were studied in relation to 28-day mortality. On admission, aVWF levels were higher in nonsurvivors vs survivors (0.69 vs 0.47 µg/mL, P = .019). Patients in the highest tertile of aVWF levels had a lower cumulative survival (86% vs 75%, P = .017) and twofold increased hazard ratio (HR). When adjusted for the Acute Physiology and Chronic Health Evaluation IV (APACHE-IV) score, this difference remained significant (HR 1.82, 95% confidence interval, 1.03-3.3). On admission, no significant differences were measured for the other proteins. These observations suggest that the stimulated release of VWF is not predictive for mortality in patients with SIRS, opposite of the processing of VWF after release. aVWF could be used with the APACHE-IV score to stratify SIRS patients at high mortality risk.
Mesh-Begriff(e)	APACHE ; Aged ; Female ; Humans ; Intensive Care Units ; Male ; Middle Aged ; Prognosis ; Severity of Illness Index ; Survival Analysis ; Systemic Inflammatory Response Syndrome/blood ; Systemic Inflammatory Response Syndrome/mortality ; Time Factors ; von Willebrand Factor/analysis
Chemische Substanzen	von Willebrand Factor
Sprache	Englisch
Erscheinungsdatum	2014-01-23
Erscheinungsland	United States
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2013-08-508093
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Subcellular FIH-1 expression patterns in invasive breast cancer in relation to HIF-1α expression.

Hyseni, Agon / van der Groep, Petra / van der Wall, Elsken / van Diest, Paul J

Cellular oncology (Dordrecht)

2011 Band 34, Heft 6, Seite(n) 565–570

Abstract: Background: Hypoxia Inducible Factor-1α (HIF-1α) expression in breast cancer is associated with a poor clinical outcome. HIF-1α shows two expression patterns: the canonical poor prognosis hypoxia-related perinecrotic pattern and a diffuse expression ... ...

Abstract	Background: Hypoxia Inducible Factor-1α (HIF-1α) expression in breast cancer is associated with a poor clinical outcome. HIF-1α shows two expression patterns: the canonical poor prognosis hypoxia-related perinecrotic pattern and a diffuse expression pattern that seems to have less downstream effects and is clearly associated with poor survival. Factor-inhibiting hypoxia-inducible factor 1 (FIH-1) inhibits HIF-1 activity by hydroxylating the C-terminal trans-activation domain of the HIF-1α subunit, thus preventing HIF-1 from recruiting co-activators CPB/p300, which are important for inducing the transcription of target genes. The aim of this study was to investigate the expression patterns of FIH-1 in breast cancer and evaluate the relationship between FIH-1 and HIF-1α expression in breast cancer as a possible explanation for apparently less downstream effects of diffuse HIF-1α expression. Methods: Tissue sections from 92 consecutive invasive breast carcinomas were stained by immunohistochemistry for FIH-1, HIF-1α, glucose transporter 1 (GLUT-1) and carbonic anhydrase IX (CAIX). Results: 45 cases overexpressed HIF-1α, 5 of which in a perinecrotic fashion while FIH-1 was positive in 73 of the 92 cases studied. Contrary to our expectations, three out of five cases with perinecrotic HIF-1α expression were also positive for FIH1. Cytoplasmic FIH-1 correlated with HIF-1α expression (P = 0.03) and tumor grade (P = 0.01). HIF-1α overexpression predicted poorer prognosis as usual (P = 0.02). FIH expression had no additional prognostic value to HIF-1α. Conclusions: FIH1 is expressed in the majority of invasive breast carcinomas and shows distinct subcellular localization patterns. FIH-1 expression does not seem to explain the proposed functional differences between diffuse and perinecrotic HIF-1α expression in breast cancer.
Mesh-Begriff(e)	Breast Neoplasms/metabolism ; Female ; Humans ; Hypoxia-Inducible Factor 1, alpha Subunit/metabolism ; Immunohistochemistry ; In Vitro Techniques ; Mixed Function Oxygenases/metabolism ; Repressor Proteins/metabolism
Chemische Substanzen	Hypoxia-Inducible Factor 1, alpha Subunit ; Repressor Proteins ; Mixed Function Oxygenases (EC 1.-) ; HIF1AN protein, human (EC 1.14.11.-)
Sprache	Englisch
Erscheinungsdatum	2011-07-06
Erscheinungsland	Netherlands
Dokumenttyp	Journal Article
ZDB-ID	2595109-9
ISSN	2211-3436 ; 1875-8606 ; 2211-3428
ISSN (online)	2211-3436
ISSN	1875-8606 ; 2211-3428
DOI	10.1007/s13402-011-0053-5
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Chronic dysfunction of the endothelium is associated with mortality in acute coronary syndrome patients.

Hyseni, Agon / Roest, Mark / Braun, Siegmund L / Barendrecht, Arjan D / de Groot, Philip G / Ndrepepa, Gjin / Kastrati, Adnan

Thrombosis research

2013 Band 131, Heft 3, Seite(n) 198–203

Abstract: Introduction: Platelet activation and endothelium dysfunction are determinants of atherothrombosis in acute coronary syndrome (ACS) patients. The aim of this study was to investigate the relationship between platelet and endothelial cell activation ... ...

Abstract	Introduction: Platelet activation and endothelium dysfunction are determinants of atherothrombosis in acute coronary syndrome (ACS) patients. The aim of this study was to investigate the relationship between platelet and endothelial cell activation markers and mortality in patients presenting with ACS. Materials and methods: Plasma levels of RANTES, Neutrophil Activating Protein-2 (NAP-2), Thrombospondin-1 (TSP-1), Von Willebrand Factor (VWF), Von Willebrand Factor Propeptide (VWF:pp) and Osteoprotegerin (OPG) were measured in a cohort study of 339 consecutive ACS patients who underwent percutaneous coronary interevention (PCI). The primary endpoint was 4-year mortality. Results: There were 46 deaths during the follow up. Median values of VWF (12.2μg/mL versus 7.86μg/mL, P=0.001) and VWF:pp (7.34nM versus 6.17nM, P=0.011) were higher in non-survivors compared to survivors. High levels of OPG were found in 37 patients: 27 of them were survivors (9.2%) and 10 were non-survivors (21.7%, P=0.011). Kaplan-Meier estimates of mortality for VWF were 7.5% in the first quartile (n=6 deaths), 12.2% in the second quartile (n=10 deaths), 11.2% in the third quartile (n=9 deaths) and 25% in the fourth quartile (n=21 deaths) of VWF (P=0.004). There was a 27.8% of probability of mortality when high OPG was measured versus 12.4% when low OPG was measured (P=0.007). No relationship between baseline platelet activation markers and mortality was found. Conclusion: In patients with ACS undergoing PCI, increased chronic endothelial cell activation and dysfunction is associated with an increased risk of long-term mortality.
Mesh-Begriff(e)	Acute Coronary Syndrome/mortality ; Acute Coronary Syndrome/pathology ; Aged ; Blood Platelets/cytology ; Chemokine CCL5/metabolism ; Coronary Vessels/pathology ; Endothelial Cells/cytology ; Endothelium, Vascular/physiopathology ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Nuclear Proteins/metabolism ; Osteoprotegerin/metabolism ; Percutaneous Coronary Intervention/adverse effects ; Prognosis ; Thrombospondin 1/metabolism ; Time Factors
Chemische Substanzen	CCL5 protein, human ; Chemokine CCL5 ; NAP1L4 protein, human ; Nuclear Proteins ; Osteoprotegerin ; Thrombospondin 1
Sprache	Englisch
Erscheinungsdatum	2013-03
Erscheinungsland	United States
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	121852-9
ISSN	1879-2472 ; 0049-3848
ISSN (online)	1879-2472
ISSN	0049-3848
DOI	10.1016/j.thromres.2012.12.001
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Sustained pro-haemostatic activity of rFVIIa in plasma and platelets in non-bleeding pigs may explain the efficacy of a once-daily prophylaxis in humans

Schut, Anne Marieke / Hyseni, Agon / Adelmeijer, Jelle / Meijers, Joost C. M. / de Groot, Philip G. / Lisman, Ton

Thrombosis and Haemostasis

2014 Band 111, Heft 08, Seite(n) 304–310

Abstract: Recombinant factor VIIa (rFVIIa) is registered for treatment of inhibitor-complicated haemophilia, and a once-daily prophylactic administration of rFVIIa is successful in reducing the number of bleeding events. This suggests that a single rFVIIa dose has ...

Abstract	Recombinant factor VIIa (rFVIIa) is registered for treatment of inhibitor-complicated haemophilia, and a once-daily prophylactic administration of rFVIIa is successful in reducing the number of bleeding events. This suggests that a single rFVIIa dose has a pro-haemostatic effect up to 24 hours (h), which is difficult to explain given its half-life of 2 h. In this study, six pigs received a 90 µg/kg rFVIIa bolus. Plasma was collected and platelets were isolated at various time points up to 48 h, and analysed for FVIIa levels and associated haemostatic activity. Elevated plasma FVIIa levels were detected up to 24 h post-administration (36 (32–56) mU/ml [median (interquartile range [IQR]), 24 h] vs 2 (2–14) mU/ml [baseline]). Corresponding prothrombin time (PT) values remained shortened compared to baseline until 24 h post-administration (9.4 (9.3–9.9) seconds (s) [24 h] vs 10.5 (10.2–11.0) s [baseline], p ≤0.01). The lag time in thrombin generation testing as well as clotting times in plasma-based assays were shortened up to 12 or 24 h post-administration, respectively (lag times 1.8 (1.7–2.1) minutes (min) [12 h] vs 2.3 (2.3–2.6) min [baseline], p ≤0.01 and clotting times 3.8 (3.2–3.9) min [24 h] vs 5.2 (4.6–5.5) min [baseline], p ≤0.001). Platelet FVIIa levels were elevated up to 48 h (7.7 (3.4–9.0) ng VIIa/mg actin [48 h] vs 2.5 (0.7–4.8) ng VIIa/mg actin [baseline]). In conclusion, elevated and haemostatically active plasma and platelet FVIIa levels are detectable up to 24–48 h following rFVIIa administration in pigs. This prolonged pro-haemostatic effect of FVIIa may explain the prophylactic efficacy of a once-daily rFVIIa treatment.
Schlagwörter	Factor VIIa ; haemophilia ; prophylaxis ; platelet ; thrombin generation
Sprache	Englisch
Erscheinungsdatum	2014-01-01
Verlag	Schattauer GmbH
Erscheinungsort	Stuttgart ; New York
Dokumenttyp	Artikel
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1160/TH13-09-0798
Datenquelle	Thieme Verlag

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Artikel ; Online: KEYNOTE - D36: personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma.

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Artikel ; Online: A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).

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Artikel ; Online: Active von Willebrand factor predicts 28-day mortality in patients with systemic inflammatory response syndrome.

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Artikel ; Online: Subcellular FIH-1 expression patterns in invasive breast cancer in relation to HIF-1α expression.

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Artikel ; Online: Chronic dysfunction of the endothelium is associated with mortality in acute coronary syndrome patients.

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Artikel: Sustained pro-haemostatic activity of rFVIIa in plasma and platelets in non-bleeding pigs may explain the efficacy of a once-daily prophylaxis in humans

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