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  1. Article ; 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  Volume 18, Issue 31, Page(s) 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 term(s) Humans ; Melanoma/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Immunotherapy ; Vaccines/therapeutic use
    Chemical Substances pembrolizumab (DPT0O3T46P) ; Antibodies, Monoclonal, Humanized ; Vaccines
    Language English
    Publishing date 2022-09-01
    Publishing country England
    Document type 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
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    Zs.A 6478: Show issues Location:
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  2. Article ; 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  Volume 21, Issue 4, Page(s) 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 term(s) 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
    Chemical Substances Dosage Forms ; Excipients ; Glycated Hemoglobin A ; Hypoglycemic Agents ; hemoglobin A1c protein, human ; Insulin Aspart (D933668QVX)
    Language English
    Publishing date 2019-01-13
    Publishing country England
    Document type 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
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    Zs.A 5442: Show issues Location:
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  3. Article ; 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  Volume 123, Issue 14, Page(s) 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 term(s) 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
    Chemical Substances von Willebrand Factor
    Language English
    Publishing date 2014-01-23
    Publishing country United States
    Document type 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
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    Zs.MO 364: Show issues

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  4. Article ; 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  Volume 34, Issue 6, Page(s) 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 term(s) Breast Neoplasms/metabolism ; Female ; Humans ; Hypoxia-Inducible Factor 1, alpha Subunit/metabolism ; Immunohistochemistry ; In Vitro Techniques ; Mixed Function Oxygenases/metabolism ; Repressor Proteins/metabolism
    Chemical Substances Hypoxia-Inducible Factor 1, alpha Subunit ; Repressor Proteins ; Mixed Function Oxygenases (EC 1.-) ; HIF1AN protein, human (EC 1.14.11.-)
    Language English
    Publishing date 2011-07-06
    Publishing country Netherlands
    Document type 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
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    Zs.A 6908: Show issues Location:
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  5. Article ; 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  Volume 131, Issue 3, Page(s) 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 term(s) 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
    Chemical Substances CCL5 protein, human ; Chemokine CCL5 ; NAP1L4 protein, human ; Nuclear Proteins ; Osteoprotegerin ; Thrombospondin 1
    Language English
    Publishing date 2013-03
    Publishing country United States
    Document type 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
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  6. Article: 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  Volume 111, Issue 08, Page(s) 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.
    Keywords Factor VIIa ; haemophilia ; prophylaxis ; platelet ; thrombin generation
    Language English
    Publishing date 2014-01-01
    Publisher Schattauer GmbH
    Publishing place Stuttgart ; New York
    Document type Article
    ZDB-ID 518294-3
    ISSN 2567-689X ; 0340-6245
    ISSN (online) 2567-689X
    ISSN 0340-6245
    DOI 10.1160/TH13-09-0798
    Database Thieme publisher's database

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