2,170 results match your criteria first-in-human clinical

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

J Endovasc Ther 2021 Jul 21:15266028211030536. Epub 2021 Jul 21.

Department of Vascular and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.

Purpose: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV.

Materials And Methods: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. Read More

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First-In-Human, First-In-Class, Phase I Trial of the Fucosylation Inhibitor SGN-2FF in Patients with Advanced Solid Tumors.

Oncologist 2021 Jul 20. Epub 2021 Jul 20.

The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Lessons Learned: Inhibition of glycoprotein fucosylation, as monotherapy and in combination with immune checkpoint blockade, is a promising therapeutic strategy for treating a broad range of cancers. In this first-in-human, first-in-class, phase I study in advanced solid tumors, SGN-2FF demonstrated dose-proportional pharmacokinetics, evidence of pharmacodynamic target inhibition of glycoprotein fucosylation, and preliminary antitumor activity. SGN-2FF was associated with thromboembolic events that led to study termination. Read More

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DRAVET ENGAGE. Parent caregivers of children with Dravet syndrome: Perspectives, needs, and opportunities for clinical research.

Epilepsy Behav 2021 Jul 17;122:108198. Epub 2021 Jul 17.

Encoded Therapeutics, Inc., South San Francisco, CA, USA.

Dravet syndrome (DS) is an intractable developmental and epileptic encephalopathy significantly impacting affected children and their families. A novel, one-time, adeno-associated virus (AAV)-mediated gene regulation therapy was designed to treat the underlying cause of DS, potentially improving the full spectrum of DS manifestations. To ensure the first-in-human clinical trial addresses meaningful outcomes for patients and families, we examined their perspectives, priorities, goals, and desired outcomes in the design phase through a mixed methods approach (quantitative and qualitative). Read More

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Magnets and self-retractable wire for endoscopic septotomies: From concept to first-in-human use.

Endoscopy 2021 Jul 19. Epub 2021 Jul 19.

Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Hopital Erasme, Bruxelles, Belgium.

Background And Study Aims: A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device in symptomatic epiphrenic esophageal diverticulum (EED). Read More

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Pilot study to determine the safety and feasibility of deceased donor liver natural killer cell infusion to liver transplant recipients with hepatocellular carcinoma.

Cancer Immunol Immunother 2021 Jul 19. Epub 2021 Jul 19.

Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

Liver transplantation (LT) is a viable treatment option for cirrhosis patients with hepatocellular carcinoma (HCC). However, recurrence is the rate-limiting factor of long-term survival. To prevent this, we conducted the phase I study of the adoptive transfer of deceased donor liver-derived natural killer (NK) cells. Read More

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Safety, tolerability, and pharmacokinetics of the novel hepatitis B virus capsid assembly modulator GST-HG141 in healthy Chinese subjects: a first-in-human single- and multiple-dose escalation trial.

Antimicrob Agents Chemother 2021 Jul 19:AAC0122021. Epub 2021 Jul 19.

Fujian Cosunter Pharmaceutical Co., Ltd., Fuzhou, China.

Hepatitis B virus capsid assembly modulators (HBV CAMs) are promising, clinically validated therapeutic agents for the treatment of chronic hepatitis B (CHB). The safety, tolerability, and pharmacokinetic (PK) profiles of GST-HG141, a novel HBV CAM, were evaluated in healthy Chinese volunteers. This phase Ia study included two parts: a double-blinded, randomized, placebo-controlled single-ascending-dose (SAD) (50, 100, 200, 300, 400, or 500 mg) study comprising a food-effect investigation (300 mg), and a multiple-ascending-dose (MAD) (100 or 200 mg BID) study. Read More

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Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study.

Contemp Clin Trials Commun 2021 Sep 29;23:100805. Epub 2021 Jun 29.

Department of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Japan.

Herniated nucleus pulposus (NP), one of the most common diseases of the spine, is surgically treated by removing the sequestered NP. However, intervertebral disc (IVD) defects may remain after discectomy, leading to inadequate tissue healing and predisposing patients to IVD degeneration. An acellular, bioresorbable, ultra-purified alginate (UPAL) gel (dMD-001) implantation system can be used to fill any IVD defects in order to prevent IVD degeneration after discectomy. Read More

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September 2021

Safety and tolerability of Miltuximab - a first in human study in patients with advanced solid cancers.

Asia Ocean J Nucl Med Biol 2021 ;9(2):86-100

Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.

Objectives: Miltuximab is a chimeric antibody targeting Glypican-1 (GPC-1), a cell surface antigen which is overexpressed in solid cancers. Miltuximab has shown promising safety and efficacy in radioimmunotherapy models of prostate cancer. This first in human study used Miltuximab radiolabelled with Gallium-67 ([Ga]Ga-DOTA-Miltuximab). Read More

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January 2021

[Pathogenesis and novel treatment of thrombotic thrombocytopenic purpura].

Rinsho Ketsueki 2021 ;62(5):480-485

Department of Blood Transfusion Medicine, Nara Medical University.

The key clinical symptoms of thrombotic thrombocytopenic purpura (TTP) are severe thrombocytopenia, microangiopathic hemolytic anemia, and organ ischemia/infarction due to microthrombi. Hemolytic anemia in TTP is characterized by mechanical damage to red blood cells. TTP is caused by a severe deficiency of ADAMTS13 activity, which is caused by mutations in the ADAMTS13 gene (congenital TTP) or by autoantibodies affecting the function or clearance of ADAMTS13 (immune TTP). Read More

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The translational and regulatory development of an implantable microdevice for multiple drug sensitivity measurements in cancer patients.

IEEE Trans Biomed Eng 2021 Jul 9;PP. Epub 2021 Jul 9.

Objective: The purpose of this article is to report the translational process of an implantable microdevice platform with an emphasis on the technical and engineering adaptations for patient use, regulatory advances, and successful integration into clinical workflow.

Methods: We developed design adaptations for implantation and retrieval, established ongoing monitoring and testing, and facilitated regulatory advances that enabled the administration and examination of a large set of cancer therapies simultaneously in individual patients.

Results: Six applications for oncology studies have successfully proceeded to patient trials, with future applications in progress. Read More

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Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting.

MAbs 2021 Jan-Dec;13(1):1938796

Translational Safety & Bioanalytical Sciences, Amgen Research (Munich) GmbH, Munich, Germany.

New challenges and other topics in non-clinical safety testing of biotherapeutics were presented and discussed at the nineth European BioSafe Annual General Membership meeting in November 2019. The session topics were selected by European BioSafe organization committee members based on recent company achievements, agency interactions and new data obtained in the non-clinical safety testing of biotherapeutics, for which data sharing would be of interest and considered as valuable information. The presented session topics ranged from strategies of testing, immunogenicity prediction, bioimaging, and developmental and reproductive toxicology (DART) assessments to first-in-human (FIH) dose prediction and bioanalytical challenges, reflecting the entire space of different areas of expertise and different molecular modalities. Read More

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Safety, pharmacokinetics and quantitative EEG modulation of TAK-071, a novel muscarinic M1 receptor positive allosteric modulator, in healthy subjects.

Br J Clin Pharmacol 2021 Jul 8. Epub 2021 Jul 8.

Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA.

Aims: TAK-071 is a muscarinic M receptor positive allosteric modulator designed to have low cooperativity with acetylcholine. This was a first-in-human study to evaluate the safety, pharmacokinetics, and pharmacodynamics of TAK-071.

Methods: TAK-071 was administered as single and multiple doses in a randomized, double-blind, placebo-controlled, parallel-group design in healthy volunteers alone and in combination with donepezil. Read More

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Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial.

Abdom Radiol (NY) 2021 Jul 9. Epub 2021 Jul 9.

Department of Medical Imaging, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.

Graphical Abstarct: PURPOSE: To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique.

Methods: A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2. Read More

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Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.

J Hematol Oncol 2021 Jul 8;14(1):108. Epub 2021 Jul 8.

Division of Hematology and Medical Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA.

Lung cancer remains the leading cause of cancer-related mortality in both men and women in the US and worldwide. Non-small cell lung cancer is the most common variety accounting for 84% of the cases. For a subset of patients with actionable mutations, targeted therapy continues to provide durable responses. Read More

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First-in-Human Trial of EphA2-Redirected CAR T-Cells in Patients With Recurrent Glioblastoma: A Preliminary Report of Three Cases at the Starting Dose.

Front Oncol 2021 21;11:694941. Epub 2021 Jun 21.

Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.

Glioblastoma is the most common primary brain malignancy with limited treatment options. EphA2 is a tumor-associated-antigen overexpressed in glioblastoma. Pre-clinical studies have demonstrated the promise of EphA2-redirected CAR T-cells against glioblastoma. Read More

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Ethical challenges for a new generation of early-phase pediatric gene therapy trials.

Genet Med 2021 Jul 7. Epub 2021 Jul 7.

Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD, USA.

After decades of setbacks, gene therapy (GT) is experiencing major breakthroughs. Five GTs have received US regulatory approval since 2017, and over 900 others are currently in development. Many of these GTs target rare pediatric diseases that are severely life-limiting, given a lack of effective treatments. Read More

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A randomized dose-escalation study on the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of a novel recombinant human albumin in healthy subjects.

Eur J Pharm Sci 2021 Jul 3;165:105923. Epub 2021 Jul 3.

Department of Hepatology, First Hospital, Jilin University, Changchun, 130021, Jilin, China. Electronic address:

Objective: Recombinant human albumin (rHA) is an alternative to human serum albumin (HSA) for treating ascites in cirrhosis patients. This study was to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics/pharmacodynamics (PK/PD) of rHA in healthy subjects to guide the design for further clinical trials.

Methods: Healthy subjects aged 18-55 years were enrolled in this double-blinded, first-in-human, placebo-controlled single ascending dose (SAD) (1. Read More

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First-in-human validation of CT-based proton range prediction using prompt gamma imaging in prostate-cancer treatments.

Int J Radiat Oncol Biol Phys 2021 Jul 3. Epub 2021 Jul 3.

OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden - Rossendorf, Dresden, Germany; Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology - OncoRay, Dresden, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; German Cancer Consortium (DKTK), partner site Dresden, Germany and German Cancer Research Center (DKFZ), Heidelberg, Germany.

Purpose: Uncertainty of CT-based range prediction is substantially impairing the accuracy of proton therapy. Direct determination of stopping-power ratio (SPR) from dual-energy CT (DECT) has been proposed (DirectSPR) and initial validation studies in phantoms and biological tissues have proven a high accuracy. However, a thorough validation of range prediction in patients has not yet been achieved by any means. Read More

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Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial): Rationale, Design, and Clinical Considerations.

Am Heart J 2021 Jul 2. Epub 2021 Jul 2.

Division of Cardiac Surgery, The Ohio State Wexner Medical Center, Columbus, OH.

Background: Patients with refractory angina (RA) have poor quality of life and new therapies are needed. XC001 is a novel adenoviral vector expressing multiple isoforms of vascular endothelial growth factor (VEGF) promoting an enhanced local angiogenic effect.

Methods: The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) trial is a 6-month (with 6-month extension) phase 1/2, first-in-human, multicenter, open-label, single-arm, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of XC001 in patients with RA. Read More

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Efficacy of clinical-grade human placental mesenchymal stromal cells in fetal ovine myelomeningocele repair.

J Pediatr Surg 2021 Jun 5. Epub 2021 Jun 5.

Department of Surgery, Division of Pediatric General, Thoracic, and Fetal Surgery, University of California Davis Medical Center, Sacramento, CA, United States; Surgical Bioengineering Laboratory, University of California Davis Medical Center, Sacramento, CA, United States.

Background: While fetal repair of myelomeningocele (MMC) revolutionized management, many children are still unable to walk independently. Preclinical studies demonstrated that research-grade placental mesenchymal stromal cells (PMSCs) prevent paralysis in fetal ovine MMC, however this had not been replicated with clinical-grade cells that could be used in an upcoming human clinical trial. We tested clinical-grade PMSCs seeded on an extracellular matrix (PMSC-ECM) in the gold standard fetal ovine model of MMC. Read More

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First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma.

Cancer Immunol Immunother 2021 Jul 3. Epub 2021 Jul 3.

START Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain.

Background: Budigalimab is a humanized, recombinant immunoglobulin G1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) expansion cohorts of the phase 1 first-in-human study of budigalimab monotherapy (NCT03000257; registered 15 December 2016).

Patients And Methods: Patients with recurrent/metastatic HNSCC or locally advanced/metastatic NSCLC naive to PD-1/PD-1-ligand inhibitors were enrolled; patients were not selected on the basis of oncogene driver mutations or PD-L1 status. Read More

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Neural stem cell delivery of an oncolytic adenovirus in newly diagnosed malignant glioma: a first-in-human, phase 1, dose-escalation trial.

Lancet Oncol 2021 Jun 29. Epub 2021 Jun 29.

Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address:

Background: Malignant glioma is the most common and lethal primary brain tumour, with dismal survival rates and no effective treatment. We examined the safety and activity of NSC-CRAd-S-pk7, an engineered oncolytic adenovirus delivered by neural stem cells (NSCs), in patients with newly diagnosed high-grade glioma.

Methods: This was a first-in-human, open-label, phase 1, dose-escalation trial done to determine the maximal tolerated dose of NSC-CRAd-S-pk7, following a 3 + 3 design. Read More

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Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results.

J Cardiovasc Electrophysiol 2021 Jul 1. Epub 2021 Jul 1.

Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Introduction: Cryoablation has evolved as a safe alternative to radiofrequency ablation in the treatment of several supraventricular arrhythmias and has potential advantages, yet is limited by the properties of the cryogen used. We investigated a novel ultralow temperature cryoablation (ULTC) system using nitrogen near its liquid-vapor critical point as a freezing source, achieving temperatures as low as -196 degrees Celsius in a long linear catheter with a continuous energy release. Initial safety, procedural and efficacy outcomes of ULTC are described in patients undergoing cavotricuspid isthmus (CTI) ablation. Read More

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First-in-human high-density epicardial mapping and ablation through a left anterior minithoracotomy in an LVAD patient presenting in electrical storm: a case report.

Eur Heart J Case Rep 2021 Jun 26;5(6):ytab248. Epub 2021 Jun 26.

Clinic for Cardio and Thoracic Surgery, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstr. 11, 32545 Bad Oeynhausen, Germany.

Background: Despite substantial technical improvements in long-term mechanical circulatory support, ventricular tachycardia (VT) remains a major challenge in left ventricular assist device (LVAD) patients. Recurrent VTs in LVAD patients are not only associated with limited quality of life, but also increased mortality. Although LVAD therapy improves VT tolerance of the left ventricle, haemodynamical deterioration of the right ventricle is the limiting factor in these patients. Read More

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Characterisation of pharmacokinetics, safety and tolerability in a first-in-human study for AZD8154, a novel inhaled selective PI3Kγδ dual inhibitor targeting airway inflammatory disease.

Br J Clin Pharmacol 2021 Jun 28. Epub 2021 Jun 28.

Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Aim: This three-part, randomised, phase 1 first-in-human study (NCT03436316) investigated the safety, tolerability and pharmacokinetics (PK) of AZD8154, a dual phosphoinositide 3-kinase (PI3K γδ) inhibitor developed as a novel inhaled anti-inflammatory treatment for respiratory disease.

Methods: Healthy men, and women of non-childbearing potential, were enrolled to receive single and multiple ascending inhaled doses of AZD8154 in parts 1 and 3 of the study, respectively, while part 2 characterised the systemic PK after a single intravenous (IV) dose. In part 1, participants received 0. Read More

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A Novel Treatment for Giant Congenital Melanocytic Nevi Combining Inactivated Autologous Nevus Tissue by High Hydrostatic Pressure and a Cultured Epidermal Autograft: First-in-Human, Open, Prospective Clinical Trial.

Plast Reconstr Surg 2021 Jul;148(1):71e-76e

From the Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University; Department of Plastic and Reconstructive Surgery, Kansai Medical University; Department of Biomedical Engineering, National Cerebral and Cardiovascular Center Research Institute; Hiroshima University Hospital Center for Integrated Medical Research; Department of Plastic and Reconstructive Surgery, National Hospital Organization Kyoto Medical Center; and JINNO Medical Skin Clinic.

Background: Giant congenital melanocytic nevi are large skin lesions associated with a risk of malignant transformation. The authors developed a novel treatment to reconstruct full-thickness skin defects by combining an inactivated nevus as the autologous dermis and a cultured epidermal autograft. The first-in-human trial of this treatment was performed. Read More

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Molecular PET/CT Profiling of ACE2 Expression In Vivo: Implications for Infection and Outcome from SARS-CoV-2.

Adv Sci (Weinh) 2021 Jun 26:e2100965. Epub 2021 Jun 26.

Key Laboratory of Carcinogenesis and Translational Research, NMPA Key Laboratory for Research Evaluation of Radiopharmaceuticals (Ministry of Education/Beijing), Department of Nuclear Medicine, Peking University Cancer Hospital and Institute, Beijing, 100142, China.

Rapid progress has been made to identify and study the causative agent leading to coronavirus disease 2019 (COVID-19) but many questions including who is most susceptible and what determines severity remain unanswered. Angiotensin-converting enzyme 2 (ACE2) is a key factor in the infection process of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). In this study, molecularly specific positron emission tomography imaging agents for targeting ACE2 are first developed, and these novel agents are evaluated in vitro, in preclinical model systems, and in a first-in-human translational ACE2 imaging of healthy volunteers and a SARS-CoV-2 recovered patient (NCT04422457). Read More

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Endotracheal Application of Ultraviolet A Light in Critically Ill Patients with Severe Acute Respiratory Syndrome Coronavirus 2: A First-in-Human Study.

Adv Ther 2021 Jun 26. Epub 2021 Jun 26.

Medically Associated Science and Technology (MAST) Program, Cedars-Sinai Medical Center, 700 N San Vicente Blvd, Suite G271, West Hollywood, CA, 90069, USA.

Introduction: Our previous preclinical experiments show that under specific and monitored conditions, ultraviolet A (UVA) exposure reduces certain bacteria, fungi, and viruses including coronavirus-229E without harming mammalian columnar epithelial cells. The goal of this study was to evaluate the safety and effects of narrow-band UVA therapy administered by a novel device via endotracheal tube in critically ill subjects with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Methods: Newly intubated, mechanically ventilated adults with SARS-CoV-2 infection and an endotracheal tube size of at least 7. Read More

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Phase I First-in-Human Dose Escalation Study of the oral SF3B1 modulator H3B-8800 in myeloid neoplasms.

Leukemia 2021 Jun 25. Epub 2021 Jun 25.

H3 Biomedicine, Cambridge, MA, USA.

We conducted a phase I clinical trial of H3B-8800, an oral small molecule that binds Splicing Factor 3B1 (SF3B1), in patients with MDS, CMML, or AML. Among 84 enrolled patients (42 MDS, 4 CMML and 38 AML), 62 were red blood cell (RBC) transfusion dependent at study entry. Dose escalation cohorts examined two once-daily dosing regimens: schedule I (5 days on/9 days off, range of doses studied 1-40 mg, n = 65) and schedule II (21 days on/7 days off, 7-20 mg, n = 19); 27 patients received treatment for ≥180 days. Read More

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Feasibility, Biodistribution and Preliminary Dosimetry in Peptide-Targeted Radionuclide Therapy (PTRT) of Diverse Adenocarcinomas using Lu-FAP-2286: First-in-Human Results.

J Nucl Med 2021 Jun 24. Epub 2021 Jun 24.

Zentralklinik Bad Berka, Germany.

Fibroblast activation protein (FAP) is a promising target for diagnosis and therapy of numerous malignant tumors. FAP-2286 is the conjugate of a FAP-binding peptide, which can be labeled with radionuclides for theranostic applications. We present the first-in-human results using Lu-FAP-2286 for peptide-targeted radionuclide therapy (PTRT). Read More

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