2024
Association between growth differentiation factor-15 and adverse outcomes among patients with heart failure: A systematic literature review
Javaheri A, Ozcan M, Moubarak L, Smoyer K, Rossulek M, Revkin J, Groarke J, Tarasenko L, Kosiborod M. Association between growth differentiation factor-15 and adverse outcomes among patients with heart failure: A systematic literature review. Heliyon 2024, 10: e35916. PMID: 39229539, PMCID: PMC11369438, DOI: 10.1016/j.heliyon.2024.e35916.Peer-Reviewed Original ResearchGDF-15 concentrationsGrowth differentiation factor 15Differentiation factor 15GDF-15Heart failureMultivariate analysisRenal functionComposite outcomeAdverse outcomesOptimal treatment regimensPredictors of mortalityCardiovascular-related mortalityCross-sectional studyPrognostic roleTreatment regimensClinical risk prediction modelsPoor outcomeRisk prediction modelExercise capacityEligibility criteriaPatientsPRISMA guidelinesMortalityNonfatal outcomesOutcomesPhase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design
Groarke J, Crawford J, Collins S, Lubaczewski S, Breen D, Harrington M, Jacobs I, Qiu R, Revkin J, Rossulek M, Saxena A. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design. Journal Of Cachexia Sarcopenia And Muscle 2024, 15: 1054-1061. PMID: 38500292, PMCID: PMC11154777, DOI: 10.1002/jcsm.13435.Peer-Reviewed Original ResearchPhysical activityPhysical functionPhase 2 studyCancer cachexiaGDF-15 concentrationsGDF-15Unintentional loss of weightLumbar skeletal muscle indexQuality of lifeSkeletal muscle indexBiomarker of cancer cachexiaNon-small-cell lungIncidence of adverse eventsResponse Evaluation CriteriaGrowth differentiation factor 15Safety laboratory testsOpen-label treatmentPlacebo-controlled studyCharacteristics of cachexiaCancer-related cachexiaMetabolic wasting syndromeHuman monoclonal antibodyCancer-relatedDifferentiation factor 15Phase 1 data
2023
A Phase 1b First-In-Patient Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ponsegromab in Participants with Cancer and Cachexia
Crawford J, Calle R, Collins S, Weng Y, Lubaczewski S, Buckeridge C, Wang E, Harrington M, Tarachandani A, Rossulek M, Revkin J. A Phase 1b First-In-Patient Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ponsegromab in Participants with Cancer and Cachexia. Clinical Cancer Research 2023, 30: 489-497. PMID: 37982848, PMCID: PMC10831332, DOI: 10.1158/1078-0432.ccr-23-1631.Peer-Reviewed Original ResearchPhase 2 study to assess the efficacy, safety, and tolerability of the GDF-15 inhibitor ponsegromab in patients with cancer cachexia.
Crawford J, Lubaczewski S, Tarachandani A, Harrington M, Weng Y, Qiu R, Collins S, Rossulek M, Revkin J. Phase 2 study to assess the efficacy, safety, and tolerability of the GDF-15 inhibitor ponsegromab in patients with cancer cachexia. Journal Of Clinical Oncology 2023, 41: tps12147-tps12147. DOI: 10.1200/jco.2023.41.16_suppl.tps12147.Peer-Reviewed Original ResearchGDF-15 concentrationsCancer cachexiaPhysical activityBody weightSelective humanized monoclonal antibodyNon-small cell lungGrowth differentiation factor 15Double-blind periodMultifactorial metabolic syndromeSafety laboratory testsUnintended weight lossWeek 12 visitPlacebo-controlled studyOpen-label treatmentPhase 2 studyDifferentiation factor 15Humanized monoclonal antibodyE max modelSkeletal muscle massQuality of lifePrimary endpointSecondary endpointsWeek 72Adverse eventsGDF-15