A5085923503- Cancer, Hypoxia, and Metabolism
- Glioma Diagnosis and Treatment
- Nanoplatforms for cancer theranostics
- Cancer Treatment and Pharmacology
- Medical Imaging Techniques and Applications
- Chemical Reactions and Isotopes
- Lung Cancer Treatments and Mutations
- SARS-CoV-2 and COVID-19 Research
- Cell death mechanisms and regulation
- Immune Cell Function and Interaction
- Monoclonal and Polyclonal Antibodies Research
- PARP inhibition in cancer therapy
- Radiopharmaceutical Chemistry and Applications
- Liver physiology and pathology
- Colorectal Cancer Treatments and Studies
- Malaria Research and Control
- Pancreatic and Hepatic Oncology Research
- Neutropenia and Cancer Infections
- Computational Drug Discovery Methods
- Immunotherapy and Immune Responses
- Axon Guidance and Neuronal Signaling
- Cancer Immunotherapy and Biomarkers
- Antibiotics Pharmacokinetics and Efficacy
- CAR-T cell therapy research
- Hepatocellular Carcinoma Treatment and Prognosis
Nucleus (Norway)
2018-2023
Breast Cancer Network Australia
2015-2023
Melbourne Clinic
2023
Baylor College of Medicine
2020
University of Maryland, Baltimore
2020
Monash Medical Centre
2012-2019
Monash University
2016
Australia and New Zealand Banking Group
2015
Leukaemia Foundation of Queensland
2003-2014
QIMR Berghofer Medical Research Institute
2003-2014
NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant.We initiated randomized, placebo-controlled, phase 1-2 trial to evaluate the safety immunogenicity rSARS-CoV-2 (in 5-μg 25-μg doses, with or without adjuvant, observers unaware trial-group assignments) in 131 healthy adults. In 1, vaccination comprised two intramuscular injections, 21 days apart....
Elayta (CT1812) is a novel allosteric antagonist of the sigma-2 receptor complex that prevents and displaces binding Aβ oligomers to neurons. By stopping key initiating event in Alzheimer's disease, this first-in-class drug candidate mitigates downstream synaptotoxicity restores cognitive function aged transgenic mouse models disease.A phase 1, two-part single multiple ascending dose study was conducted 7 4 cohorts healthy human subjects, respectively. In part A, healthy, young subjects (<65...
PG545 (pixatimod) is a novel immunomodulatory agent, which has been demonstrated to stimulate innate immune responses against tumours in preclinical cancer models. This Phase I study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of monotherapy. Escalating doses were administered patients with advanced solid malignancies as weekly 1-h intravenous infusion. Twenty-three subjects enrolled across four cohorts (25, 50, 100 150 mg). Three...
Background The Vaxxas high-density microarray patch (HD-MAP) consists of a high density microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer possibility improved thermostability as well potential to be safer, more acceptable, easier use, and cost-effective administration vaccines than injection by needle syringe (N&S). Here, we report phase I trial using HD-MAP deliver monovalent influenza that was best our knowledge first clinical evaluate safety,...
Abstract Background Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine could be a benefit, requiring 1 rather than 2 visits to healthcare provider for individuals receiving vaccines. Methods The primary immunogenicity objective this phase 3, 1:1 randomized, double-blind, placebo-controlled study healthy adults aged ≥65 years Australia was demonstrate noninferiority immune responses...
Abstract ARC‐520 Injection, an RNA interference drug for the treatment of hepatitis B that targets cccDNA‐derived viral mRNA transcripts with high specificity, effectively reduces production proteins and HBV DNA. In this phase 1 randomized, double‐blind, placebo‐controlled study, 54 healthy volunteers (half male, half female) received a single, intravenous dose 0.01–4.0 mg/kg Injection (n = 36) or placebo 18). Assessments included safety, tolerability, pharmacokinetics, pharmacodynamics...
PEGylated carboxyhemoglobin bovine (SANGUINATE) is a dual action carbon monoxide releasing (CO)/oxygen (O2) transfer agent for the treatment of hypoxia. Its components inhibit vasoconstriction, decrease extravasation, limit reactive oxygen species production, enhance blood rheology, and deliver to tissues. Animal models cerebral ischemia, peripheral myocardial ischemia demonstrated SANGUINATE's efficacy in reducing infarct size, limiting necrosis from promoting more rapid recovery hind limb...
BackgroundStreptococcus pyogenes is a leading cause of infection-related morbidity and mortality. A reinvigorated vaccine development effort calls for new clinically relevant human S experimental infection models to support proof concept evaluation candidate vaccines. We describe the initial Controlled Human Infection Vaccination Against (CHIVAS-M75) study, in which we aimed identify dose emm75 that causes acute pharyngitis at least 60% volunteers when applied pharynx by swab.MethodsThis...
Abstract Purpose: Fluorescence-guided surgery using tumor-targeted contrast agents has been developed to improve the completeness of oncologic resections. Quenched activity–based probes that fluoresce after covalently binding tumor-specific enzymes have proposed specificity, but none tested in humans. Here, we report successful clinical translation a cathepsin probe (VGT-309) for fluorescence-guided surgery. Experimental Design: We optimized dosing, and timing VGT-309 preclinical models lung...
Aberrant activation of MET (hepatocyte growth factor receptor) signaling is implicated in the tumorigenesis human cancers. This phase I study assessed safety, tolerability, and MTD potent selective inhibitor, savolitinib (AZD6094, HMPL-504, volitinib).This open-label, multicenter dose-escalation -expansion evaluated oral for patients with locally advanced or metastatic solid tumors. A 3 + design repeated daily (QD) twice (BID) dosing schedules. The dose-expansion included 12 patients....
There is an unmet medical need for vaccines to prevent dengue. V180 investigational recombinant subunit vaccine that consists of truncated dengue envelope proteins (DEN-80E) all 4 serotypes. Three dosage levels the tetravalent DEN-80E antigens were assessed in a randomized, placebo-controlled, Phase I dose-escalation, first-in-human proof-of-principle trial healthy, flavivirus-naïve adults Australia (NCT01477580). The 9 formulations included either ISCOMATRIX™ adjuvant (2 levels),...
Abstract Background NVX-CoV2373 is a recombinant nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins. We present the Day 35 primary analysis our trial with or without saponin-based Matrix-M1 adjuvant in healthy adults. Methods This randomized, observer-blinded, placebo-controlled, phase 1 131 Trial vaccination comprised two intramuscular injections, 21 days apart. Primary outcomes were reactogenicity, safety labs, and immunoglobulin G (IgG) anti-spike protein...
Tigilanol tiglate, a short-chain diterpene ester, is being developed as intratumoral treatment of broad range cancers. We conducted the first-in-human study tigilanol tiglate in patients with solid tumors.Tigilanol was administered multicentre, non randomized, single-arm study, escalating doses beginning 0·06 mg/m2 tumors estimated to be at least twice volume injection (dose-escalation cohorts). Patients smaller were assigned local effects cohort and received appropriate dose for tumor...
Respiratory syncytial virus (RSV) causes bronchiolitis and pneumonia in neonates infants. RSV vaccination during pregnancy could boost preexisting neutralizing antibody titers, providing passive protection to newborns.
Aims This study investigated the safety, tolerability and pharmacokinetics after administration of a specific Cannabis sativa cultivar extract, standardised to cannabidiol (CBD) content as sublingual wafer or oil formulation compared nabiximols oromucosal spray. Methods For single‐dose study, design was an open‐label, 4‐way crossover in 12 healthy volunteers randomised receive sequence 4 different single doses CBD (25 50 mg CBD), solution (50 spray (20 CBD, 21.6 tetrahydrocannabinol)....
GSK2849330, an anti-HER3 monoclonal antibody that blocks HER3/Neuregulin 1 (NRG1) signaling in cancer cells, is engineered for enhanced antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This phase I, first-in-human, open-label study assessed the safety, pharmacokinetics (PK), pharmacodynamics, preliminary activity of GSK2849330 patients with HER3-expressing advanced solid tumors.Patients various tumor types were prospectively selected HER3 expression by...
Abstract Purpose Evaluate the pharmacodynamics, pharmacokinetics, and safety of paltusotine, an orally bioavailable, nonpeptide, somatostatin receptor subtype 2 (SST2) agonist being developed for treatment acromegaly neuroendocrine tumors. Methods A randomized, double-blind, placebo-controlled, single center, multiple ascending dose phase 1 study was conducted in healthy male volunteers who received (i) single-dose oral paltusotine 1.25, 2.5, 5, 10, 20 mg (solution); 40 60 (capsules) or (ii)...
ABSTRACT AT-752 is a novel guanosine nucleotide prodrug inhibitor of the dengue virus (DENV) polymerase with sub-micromolar, pan-serotype antiviral activity. This phase 1, double-blind, placebo-controlled, first-in-human study evaluated safety, tolerability, and pharmacokinetics ascending single multiple oral doses in healthy subjects. was well tolerated when administered as dose up to 1,500 mg or 750 three times daily (TID). No serious adverse events occurred, majority treatment-emergent...