2023
A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumors: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS).
LoRusso P, Gounder M, Yamamoto N, Patel M, Bauer T, Geng J, Sailer R, Tang Y, Jayadeva G, Schöffski P. A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumors: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS). Journal Of Clinical Oncology 2023, 41: 11554-11554. DOI: 10.1200/jco.2023.41.16_suppl.11554.Peer-Reviewed Original ResearchTreatment-related AEsProgression-free survivalManageable safety profileOverall response rateDedifferentiated liposarcomaSafety profileCohort 1Day 1Phase IbSolid tumorsMedian progression-free survivalDisease control rateECOG PS 0/1MDM2-p53 antagonistsPrior systemic therapySmall intestine obstructionSubgroups of ptsAdvanced solid tumorsFirst-line treatmentPreclinical antitumor activityFast track designationIA/IBPS 0/1Serious AEsPrimary endpoint
2020
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approval
2015
Immune regulatory and neuroprotective properties of preimplantation factor: From newborn to adult
Barnea E, Almogi-Hazan O, Or R, Mueller M, Ria F, Weiss L, Paidas M. Immune regulatory and neuroprotective properties of preimplantation factor: From newborn to adult. Pharmacology & Therapeutics 2015, 156: 10-25. PMID: 26546485, DOI: 10.1016/j.pharmthera.2015.10.008.Peer-Reviewed Original ResearchConceptsPreImplantation FactorNeurological disordersAdverse maternal environmentSynthetic preimplantation factorEarly adverse eventsHigh safety profileFast track designationComplex neurological disorderEmbryonic-maternal interactionColon ulcerationPIF's effectHost diseaseLeukemia effectAdverse eventsLiver inflammationTransplant acceptanceBrain infectionNeuroprotective effectsAutoimmune disordersImmune suppressionNeuroprotective propertiesImmune modulationNeonatal prematuritySupraphysiological dosesSkin ulceration
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