Search results for " Investigational"

showing 10 items of 20 documents

Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspecti…

2021

International audience; Extracellular vesicles (EV) are emergent therapeutic effectors that have reached clinical trial investigation. To translate EV-based therapeutic to clinic, the challenge is to demonstrate quality, safety, and efficacy, as required for any medicinal product. EV research translation into medicinal products is an exciting and challenging perspective. Recent papers, provide important guidance on regulatory aspects of pharmaceutical development, defining EVs for therapeutic applications and critical considerations for the development of potency tests. In addition, the ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics as well as the Exosomes C…

Quality ControlKnowledge management[SDV.BIO]Life Sciences [q-bio]/BiotechnologyBiological medicinal productsmedia_common.quotation_subjectDrug Compounding[SDV]Life Sciences [q-bio]Regulatory requirementsPharmaceutical ScienceMarketing authorizationExosomesChemistry Techniques Analytical03 medical and health sciencesExtracellular Vesicles0302 clinical medicineDrug DevelopmentDrug Stability[CHIM]Chemical SciencesHumansQuality (business)ComputingMilieux_MISCELLANEOUS030304 developmental biologymedia_commonCell-free therapySecretome0303 health sciencesClinical Trials as TopicClinical-grade EVScientific progressbusiness.industryDrug Administration RoutesExtracellular vesicleDrugs InvestigationalRegulatory affairs3. Good health[SDV.BIO] Life Sciences [q-bio]/BiotechnologyClinical trialEuropeAnalytics030220 oncology & carcinogenesisPosition paperMedicinal productsBusinessMicrovesicles
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Targeted therapy for hepatocellular carcinoma: novel agents on the horizon.

2012

Hepatocellular carcinoma (HCC) is the most common liver cancer, accounting for 90% of primary liver cancers. In the last decade it has become one of the most frequently occurring tumors worldwide and is also considered to be the most lethal of the cancer systems, accounting for approximately one third of all malignancies. Although the clinical diagnosis and management of early-stage HCC has improved significantly, HCC prognosis is still extremely poor. Furthermore, advanced HCC is a highly aggressive tumor with a poor or no response to common therapies. Therefore, new effective and well-tolerated therapy strategies are urgently needed. Targeted therapies have entered the field of anti-neopl…

SorafenibOncologymedicine.medical_specialtyPathologyCarcinoma Hepatocellularmedicine.medical_treatmentReviewsAntineoplastic AgentsDiseasesignal transduction inhibitorsModels BiologicalTargeted therapyInternal medicinemedicineCarcinomacancerAnimalsHumansMolecular Targeted TherapyHCCneoplasmsCause of deathbusiness.industryTherapies InvestigationalLiver NeoplasmsCancerDrugs Investigationalmedicine.diseasetargeted therapyVEGFdigestive system diseasesOncologyHepatocellular carcinomaRas/Raf/MEK/ERKHCC targeted therapy VEGF Ras/Raf/MEK/ERK PI3K/Akt/PTEN/mTOR signal transduction inhibitors cancPI3K/Akt/PTEN/mTORLiver cancerbusinessmedicine.drugSignal Transduction
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Conquests and perspectives of cardio-oncology in the field of tumor angiogenesis-targeting tyrosine kinase inhibitor-based therapy

2015

Abstract: Introduction: Angiogenesis is fundamental for tumor development and progression. Hence, anti-angiogenic drugs have been developed to target VEGF and its receptors (VEGFRs). Several tyrosine kinase inhibitors (TKIs) have been developed over the years and others are still under investigation, each anti-VEGFR TKI showing a different cardiotoxic profile. Knowledge of the cardiac side-effects of each drug and the magnitude of their expression and frequency can lead to a specific approach. Areas covered: This work reviews the mechanism of action of anti-VEGFR TKIs and the pathophysiological mechanisms leading to cardiotoxicity, followed by close examination of the most important drugs i…

SorafenibOncologymedicine.medical_specialtymedicine.drug_classSettore MED/06 - Oncologia MedicaAntineoplastic AgentsPharmacologyVandetanibModels BiologicalTyrosine-kinase inhibitorPazopanibchemistry.chemical_compoundInternal medicineRegorafenibNeoplasmsmedicineHumansPharmacology (medical)Molecular Targeted TherapyProtein Kinase Inhibitorstyrosine kinase inhibitor cardiac toxicityNeovascularization PathologicSunitinibbusiness.industryPharmacology. TherapyCancerHeartGeneral MedicineDrugs InvestigationalProtein-Tyrosine Kinasesmedicine.diseaseAxitinibReceptors Vascular Endothelial Growth FactorchemistryCardiovascular Diseasesbusinessmedicine.drug
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A critical evaluation of caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura

2020

Introduction: Acquired thrombotic thrombocytopenic purpura (aTTP) is a thrombotic microangiopathy caused by inhibitory autoantibodies against ADAMTS13 protein. Until recently, the combination of plasma exchange (PEX) and immunosuppression has been the standard front-line treatment in this disorder. However, aTTP-related mortality, refractoriness, and relapse are still a matter of concern. Areas covered: The better understanding of the pathophysiological mechanisms of aTTP has allowed substantial improvements in the diagnosis and treatment of this disease. Recently, the novel anti-VWF nanobody caplacizumab has been approved for acute episodes of aTTP. Caplacizumab is capable to block the adh…

Thrombotic microangiopathyExacerbationvirusesmedicine.medical_treatmentADAMTS13 ProteinDiseaseBioinformaticsAutoantigens03 medical and health sciencesPlatelet Adhesiveness0302 clinical medicineFibrinolytic AgentsProtein DomainsCrotalid Venomsvon Willebrand FactormedicineHumansImmunologic FactorsMulticenter Studies as TopicLectins C-TypeMolecular Targeted TherapyDrug ApprovalClinical Trials as TopicAcquired Thrombotic Thrombocytopenic PurpuraPlasma ExchangePurpura Thrombotic Thrombocytopenicbusiness.industryStandard treatmentfungiImmunosuppressionDrugs InvestigationalHematologyAptamers NucleotideSingle-Domain Antibodiesbiochemical phenomena metabolism and nutritionmedicine.diseaseCombined Modality TherapyRecombinant ProteinsADAMTS13AcetylcysteineTreatment Outcome030220 oncology & carcinogenesisDrug Therapy CombinationCaplacizumabbusinessImmunosuppressive Agents030215 immunologyExpert Review of Hematology
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Phosphatidylcholine liposomes as carriers to improve topical ascorbic acid treatment of skin disorders

2015

Gabriel Serrano,1,* Patricia Almudéver,2,* Juan-Manuel Serrano,1 Javier Milara,2–5 Ana Torrens,1 Inmaculada Expósito,1 Julio Cortijo2–51Sesderma Laboratorios, 2Department of Pharmacology, Faculty of Medicine, University of Valencia, 3Clinical Research Unit, University General Hospital Consortium, 4CIBERES, Health Institute Carlos III, 5Research Foundation of the University General Hospital of Valencia, Valencia, Spain*These authors contributed equally to this workAbstract: Liposomes have been intensively investigated as carriers for different applications in dermatology and cosmetics. Ascorbic acid has potent antioxidant and anti-inflammatory proper…

liposomesSodium ascorbateLiposomefluoresceinintegumentary systembusiness.industryHuman skinDermatologyAscorbic acidskin absorptionchemistry.chemical_compoundmedicine.anatomical_structureClinical Cosmetic and Investigational DermatologyDermischemistryPhosphatidylcholineImmunologyBiophysicsStratum corneumMedicineFluoresceinbusinessphosphatidylcholinesodium ascorbateOriginal ResearchClinical, Cosmetic and Investigational Dermatology
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Microneedling dilates the follicular infundibulum and increases transfollicular absorption of liposomal sepia melanin

2015

Gabriel Serrano,1 Patricia Almudéver,2 Juan M Serrano,3 Julio Cortijo,2 Carmen Faus,1 Magda Reyes,1 Inmaculada Expósito,3 Ana Torrens,3 Fernando Millán1 1Clínica Dermatológica Serrano, 2Department of Pharmacology, University of Valencia, 3Research and Development Department, Sesderma Laboratories, Valencia, Spain Abstract: Encapsulation of chemicals in liposomes and microneedling are currently used techniques to enhance the penetration of several substances through skin and hair. In this study, we apply a liposomal melanin–fluorescein compound to an ex vivo model of human skin, using a new electrical microneedling device (Nano…

liposomeshair removalmedicine.medical_specialtymedicine.medical_treatmentfollicular infundibulumHuman skinDermatologyInfundibulumMelaninFluorescence microscopemedicineSepiaLaser hair removalOriginal ResearchLiposomeintegumentary systembusiness.industryPenetration (firestop)melaninSurgerymedicine.anatomical_structureClinical Cosmetic and Investigational DermatologyBiophysicssense organsbusinessmicroneedlingClinical, Cosmetic and Investigational Dermatology
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Anti-endothelin drugs in solid tumors

2010

Importance of the field: The endothelin (ET) axis, which includes the biological functions of ETs and their receptors, has played a physiological role in normal tissue, acting as a modulator of vasomotor tone, tissue differentiation and development, cell proliferation and hormone production. Interestingly, it also functions in the growth and progression of various tumors. Several researchers have identified the blockade of the ET-1 receptor as a promising therapeutic approach. Areas covered in this review: The clinical investigation of an orally bioavailable ET antagonist, atrasentan, in prostate cancer, is encouraging. In this neoplasia, it has shown antitumor activity, bone metastasis con…

medicine.hormoneEndothelin Receptor AntagonistsMalemedicine.medical_specialtyPyrrolidinesSettore MED/06 - Oncologia Medicaatrasentan endothelins prostate cancer zibotentanModels BiologicalEndothelinsProstate cancerchemistry.chemical_compoundDrug Delivery SystemsInternal medicineNeoplasmsAntineoplastic Combined Chemotherapy ProtocolsmedicineHumansPharmacology (medical)ReceptorPharmacologyZibotentanbusiness.industryReceptors EndothelinEndothelinsAtrasentanBone metastasisProstatic NeoplasmsDrugs Investigationalmedicine.diseaseBlockadeEndocrinologychemistryAtrasentanCancer researchEndothelin receptorbusinessmedicine.drugSignal Transduction
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Emerging therapies for raising high-density lipoprotein cholesterol (HDL-C) and augmenting HDL particle functionality.

2014

High-density lipoprotein (HDL) particles are highly complex polymolecular aggregates capable of performing a remarkable range of atheroprotective functions. Considerable research is being performed throughout the world to develop novel pharmacologic approaches to: (1) promote apoprotein A-I and HDL particle biosynthesis; (2) augment capacity for reverse cholesterol transport so as to reduce risk for the development and progression of atherosclerotic disease; and (3) modulate the functionality of HDL particles in order to increase their capacity to antagonize oxidation, inflammation, thrombosis, endothelial dysfunction, insulin resistance, and other processes that participate in arterial wal…

medicine.medical_specialtyEndocrinology Diabetes and MetabolismRVX 208BiologyBioinformaticschemistry.chemical_compoundEndocrinologyInsulin resistanceHigh-density lipoproteinInternal medicinemedicineHumansEndothelial dysfunctionLiver X receptorDyslipidemiasTherapies InvestigationalReverse cholesterol transportCholesterol HDLGenetic Therapymedicine.diseaseUp-RegulationEndocrinologychemistryCardiovascular Diseaseslipids (amino acids peptides and proteins)Farnesoid X receptorLipoproteinBest practiceresearch. Clinical endocrinologymetabolism
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Investigational agents for Crohn's disease.

2010

IMPORTANCE OF THE FIELD: Increased understanding of the biological mechanisms of Crohn's disease has opened the door to a large number of new molecules; some of these are approved for clinical use, while others remain under evaluation. In this review, we examine the clinical efficacy of all the new drugs that have been evaluated in controlled trials in the last 12 years. AREAS COVERED IN THIS REVIEW: Anti-TNF therapy has been reviewed briefly, given the many comprehensive reviews on this topic; attention is focused mainly on the other biological therapies. In assessing the clinical efficacy of these molecules, we consider only the remission rate, as this is considered the most meaningful en…

medicine.medical_specialtybiological therapy. Crohn' s disease. Integrins.Probiotics.Small molecules.DiseaseAdaptive ImmunityReceptors Tumor Necrosis FactorCrohn DiseaseGastrointestinal AgentsmedicineHumansImmunologic FactorsPharmacology (medical)Clinical efficacyIntensive care medicineRandomized Controlled Trials as TopicPharmacologyMitogen-Activated Protein Kinase KinasesBiological therapiesCrohn's diseaseEverolimusEnd pointINVESTIGATIONAL AGENTSbusiness.industryRemission InductionAntibodies MonoclonalGeneral MedicineDrugs Investigationalmedicine.diseaseImmunity InnateImmunologyCytokinesRemission rateImmunotherapybusinessCell Adhesion Moleculesmedicine.drugExpert opinion on investigational drugs
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Efficacy of Oxybrasion and Cosmetic Acids on Selected Skin Parameters in the Treatment with Acne Vulgaris

2023

Karolina Chilicka,1 Monika Rusztowicz,1 Aleksandra M Rogowska,2 Renata Szyguła,1 Danuta Nowicka3 1Department of Health Sciences, Institute of Health Sciences, University of Opole, Opole, Poland; 2Department of Social Sciences, Institute of Psychology, University of Opole, Opole, Poland; 3Department of Dermatology, Venereology and Allergology, Wrocław Medical University, Wrocław, PolandCorrespondence: Karolina Chilicka, Department of Health Sciences, Institute of Health Sciences, University of Opole, Katowicka 68 Street, Opole, 45-040, Poland, Tel +48665439443, Email karolina.chilicka@uni.opole.plPurpose: The present study aimed to evaluate the efficacy of an…

oxybrasionClinical Cosmetic and Investigational Dermatologycorneometeracne vulgarisDermatologysebumetercosmetic acidsClinical, Cosmetic and Investigational Dermatology
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