Venex (diosmin) / Elder Pharma - LARVOL DELTA

Integrating Computational Cytomorphological Analysis of Bone Marrow Smears and Clinical Data for Predicting Response to Venetoclax and Hypomethylating Agents in AML (ASH 2024) - P2 | "Methods We collected clinical data and cytomorphological BM slides from 100 AML patients treated with Ven+HMA, including 79 patients from the nationwide VenEx trial (NCT04267081, Kuusanmäki, Haematologica 2023) by the Finnish AML Study Group and 21 patients treated at the Helsinki University Hospital outside the trial. Recent developments in computer vision permit reliable quantitative analysis of BM morphology and add a novel data modality to predictive modeling. Future work will focus on further exploring quantitative cytomorphology and linking it with other modalities and predictive assays."

Clinical data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH2 • NPM1

AZACITIDINE IN COMBINATION WITH REDUCED DURATION VENETOCLAX IN PATIENTS WITH DE NOVO; SECONDARY; AND RELAPSE/REFRACTORY ACUTE MYELOID LEUKEMIA: INTERIM ANALYSIS OF THE PROSPECTIVE NAMLG LD-VENEX TRIAL (EHA 2025) - P2 | "CRc rates and mOS for sAML (46%, 10.3 mo) and R/R AML (61%, 13.0 mo) exceeded full-dose VEN/AZA in the prospective VenEx trial (sAML+R/R AML 39%, 8.4 mo) (5) as well as prior trials (6) and real-world evidence (7–10). TEAE grade ≥ 3 were slightly reduced compared to Viale-A results, particularly thrombocytopenia (25% vs. 45%)"

Clinical • Combination therapy • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia • TP53

AZACITIDINE IN COMBINATION WITH REDUCED DURATION VENETOCLAX IN PATIENTS WITH DE NOVO, SECONDARY, AND RELAPSE/REFRACTORY ACUTE MYELOID LEUKEMIA: INTERIM ANALYSIS OF THE PROSPECTIVE NAMLG LD-VENEX TRIAL (EHA 2025) - P2 | "Efficacy of VEN/AZA treatment with shortened VEN duration is comparable to full-dose VEN/AZA. CRc rates and mOS for dnAML (70%, 17.6 mo) corresponded to Viale-A results (66.8%, 14.7 mo) (3,4). CRc rates and mOS for sAML (46%, 10.3 mo) and R/R AML (61%, 13.0 mo) exceeded full-dose VEN/AZA in the prospective VenEx trial (sAML+R/R AML 39%, 8.4 mo) (5) as well as prior trials (6) and real-world evidence (7-10)."

Clinical • Combination therapy • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia • TP53

VenEx precisely predicts ven-aza response. (PubMed, Blood) - No abstract available

Journal

Ex Vivo Venetoclax Sensitivity Predicts Clinical Response in Acute Myeloid Leukemia in the Prospective VenEx Trial. (PubMed, Blood) - P2 | "We evaluated the utility of ex vivo venetoclax sensitivity testing to predict treatment responses to venetoclax-azacitidine in a prospective, multicenter, phase 2 trial conducted by the Finnish AML Group (VenEx, NCT04267081). In univariate and multivariate analysis, ex vivo venetoclax sensitivity was the strongest predictor for a favorable treatment response and survival. The VenEx trial demonstrates the feasibility of integrating ex vivo drug testing into clinical practice to identify AML patients, particularly in the R/R setting, who benefit from venetoclax."

Journal • Preclinical • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Complications of cyanoacrylate adhesive closure therapy in chronic venous insufficiency: A single center, single-surgeon study. (PubMed, Phlebology) - "Although CAC therapy is a reliable method, its complications should not be ignored. Its use by experienced surgeons reduces the risk of complications."

Journal • Cardiovascular • Dermatology • Hematological Disorders • Ophthalmology • Pulmonary Embolism • Respiratory Diseases • Venous Thromboembolism

BCL-2/BCL-XL INHIBITION INDUCES APOPTOSIS AND CIRCUMVENTS VENETOCLAX RESISTANCE IN TP53-MUTATED ACUTE MYELOID LEUKEMIA (EHA 2023) - P2 | " 109 AML samples' blast-specific ex vivo responses to venetoclax (BCL-2 inhibitor), navitoclax (BCL-2/BCL-XL inhibitor), A-1331852 (BCL-XL inhibitor) and S-63845 (MCL-1 inhibitor) were profiled by flow cytometry... In the computational comparison analysis of VenEx trial participants' genetic aberrations and BH3 mimetic ex vivo responses, TP53 mutation (p=0.005) and complex karyotype (p=0.003) were the strongest predictors of venetoclax resistance, while IDH2 (p=0.006) and SRSF2 (p=0.007) mutations predicted favorable responses (Figure A)... This study showed that AML patients harboring TP53 mutations have reduced ex vivo sensitivity to venetoclax, which might be associated with decreased BCL-2 protein expression. In contrast, our BH3 mimetic drug screening results demonstrated that the dual inhibition of BCL-2 and BCL-XL by navitoclax is capable of inducing apoptosis in myeloid blast cells regardless of TP53 mutation status. However, larger patient cohorts..."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2 • BCL2L1 • CD34 • IDH2 • SRSF2 • TP53

CAPILLARY BLOOD SAMPLING ALLOWS FEASIBLE METHOD FOR VENETOCLAX CONCENTRATION MEASUREMENT IN AN ACADEMIC MULTICENTER CLINICAL TRIAL CONTEXT (EHA 2023) - P2 | "Aims: We collected capillary blood for venetoclax trough concentration (C min ) analysis within our VenEx trial (NCT04267081)...The first three 28-day cycles of the therapy consisted of azacytidine (75mg/m 2 for 7 days) and venetoclax (400mg daily for 21-28 days)... The C1d15 capillary blood C min correlated excellently (R 2 0.835, p<0.001) with the parallel plasma concentration (fig 1A) demonstrating the feasibility of the assay. In the whole population, median capillary blood C min was 720 (58-12600) ng/L in C1d15 and 846 (134-9790) ng/L in C2d15. There was no significant correlation between age (R 2 0,017, p = 0.115) or weight (R 2 0,003, p = 0.486) and C min on d15."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CYP3A4 • CYP3A5

Ex Vivo Venetoclax Sensitivity Testing Predicts Response and Overall Survival in De Novo and s/R/R AML Patients Treated with Azacitidine and Venetoclax (ASH 2022) - P2 | "In the VenEx trial we used ex vivo Ven-sensitivity testing to predict therapy response and overall survival. Leukemic blast-specific ex vivo Ven-sensitivity showed a high correlation with treatment responses, and univariate analysis showed Ven-sensitivity to be the best predictor for treatment response. Further, ex vivo Ven-sensitivity predicted longer OS – and importantly, this was also observed in R/R/sAML pts, suggesting the method's usefulness in selecting pts for Ven-Aza therapy."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • ANXA5 • FLT3 • KIT • TP53

Ex vivo venetoclax sensitivity testing predicts treatment response in acute myeloid leukemia. (PubMed, Haematologica) - P2 | "Here we report the results of the first stage of the prospective Phase 2 VenEx trial evaluating the utility and predictiveness of venetoclax sensitivity testing using different cell culture conditions and cell viability assays in patients receiving venetoclax-azacitidine (NCT04267081). 001). T his analysis illustrates the feasibility of integrating drug-response profiling into clinical practice and demonstrates excellent predictivity."

IO biomarker • Journal • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Ex Vivo Drug Sensitivity Testing to Predict Response to Venetoclax + Azacitidine in Acute Myeloid Leukemia: Interim Results of the Prospective Multicenter Phase II Venex Trial (ASH 2021) - P2 | "Notably, experimental conditions had considerable influence on the predictive value of ex vivo Ven sensitivity; thus, between-trial standardization is crucial. The ongoing VenEx trial will validate these findings in the second part of the trial (60 pts) where ex vivo Ven sensitivity guides therapy in pts with R/R or sAML."

IO biomarker • P2 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH2 • TP53

Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Ain Shams University

New P3 trial • Pain • IL1B

Use of Haddenham Venex armsleeve for lymphoedema management in clinical practice. (PubMed, Br J Community Nurs) - "This article examines how, following recent improvements to the comfort and overall fit of the Haddenham Venex lymphoedema sleeve, patient feedback informed the implementation of further modifications, and how gaining feedback from patients has empowered them to manage and monitor their own condition. By taking ownership for their own care, long-term control of the condition is improved and self-management is enhanced."

Clinical • Journal

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