UNIVERSITY OF MELBOURNE
🇦🇺Australia
- Country
- 🇦🇺Australia
- Ownership
- Private
- Established
- 1853-01-01
- Employees
- 5K
- Market Cap
- -
- Website
- http://www.unimelb.edu.au
Glucotrack Secures Ethical Approval for Long-Term Clinical Study of Implantable Blood Glucose Monitor
• Glucotrack has received ethical approval from St. Vincent's Hospital Melbourne HREC for a year-long clinical study of its implantable continuous blood glucose monitor in patients with type 1 and type 2 diabetes.
• The multi-center study will enroll up to 30 participants requiring intensive insulin therapy, with first implantations expected by July 2025 and potential extension to three years of monitoring.
• Unlike traditional CGMs that measure glucose in interstitial fluid, Glucotrack's device directly measures blood glucose with no wearable component and is designed to function for up to three years.
Engineered "Invisible" Brain Cells Reverse Parkinson's Symptoms in Preclinical Study
• Australian researchers have developed human brain cells with an "invisibility cloak" that evades immune detection, successfully restoring muscle function in rat models of Parkinson's disease without requiring immunosuppressant drugs.
• The engineered cells contain eight modified genes that mimic natural immune evasion mechanisms found in placenta and cancer cells, creating a potential "universal" cell line for transplantation across multiple neurological conditions.
• This breakthrough could eliminate the need for anti-rejection medications that increase infection risk and cause tissue damage, representing a significant advancement toward off-the-shelf cell therapies for conditions including Parkinson's, stroke, and Huntington's disease.
FDA Approves Groundbreaking Technologies for Epilepsy Monitoring: Embrace Smartwatch and Minder Implantable EEG System
• The FDA has approved Empatica's Embrace smartwatch, which uses machine learning and electrodermal activity monitoring to detect generalized tonic-clonic seizures with 100% accuracy in clinical trials.
• Epiminder's Minder system has received FDA De Novo classification and Breakthrough Device designation as the first implantable continuous EEG monitoring system that can track brain activity for months or years.
• These innovations address critical gaps in epilepsy management, potentially reducing the 3,000+ annual deaths from Sudden Unexpected Death in Epilepsy (SUDEP) and improving care for the 3.4 million Americans with epilepsy.
FDA Approves Genentech's TNKase for Acute Ischemic Stroke with Simplified Administration
• The FDA has approved Genentech's TNKase, a clot-dissolving agent, for treating acute ischemic stroke in adults, marking the company's second stroke treatment approval.
• TNKase offers a streamlined five-second intravenous bolus administration, presenting a significant advantage over the current standard treatment Activase's 60-minute infusion protocol.
• The approval is supported by a multi-center non-inferiority study across 22 Canadian stroke centers, demonstrating comparable safety and efficacy to Activase in patients with disabling neurological deficits.
Major ICU Trial Tests High-Protein Enteral Formula in Critical Care Patients Across Australia and New Zealand
• The TARGET Protein trial is evaluating augmented protein enteral formula versus standard formula across eight ICUs in Australia and New Zealand using a cluster randomized, cross-over design.
• The study aims to enroll approximately 3,000 critically ill patients to determine if higher protein delivery improves hospital-free days alive at 90 days post-admission.
• The trial compares Nutrison Protein Intense® (100g protein/1000ml) against standard Nutrison Protein Plus® (63g protein/1000ml) in a pragmatic design using existing clinical databases for outcome assessment.
ARX788 Demonstrates Significant PFS Benefit in HER2-Positive Breast Cancer
• A phase III trial of ARX788 showed a significantly longer median progression-free survival (PFS) of 11.3 months compared to 8.2 months with lapatinib plus capecitabine (LC) in HER2-positive advanced breast cancer patients.
• The objective response rate (ORR) was higher in the ARX788 group (63.8%) compared to the LC group (52.7%), with a significantly longer duration of response (DoR) of 12.5 months versus 8.3 months.
• ARX788 demonstrated a manageable safety profile, with the most frequent treatment-related adverse events (TRAEs) including hepatic enzyme increase, dry eye, blurred vision, alopecia, and interstitial lung disease (ILD).
• The study suggests ARX788 could be an alternative second-line treatment option for HER2-positive advanced breast cancer patients who have progressed on trastuzumab and taxane.
Wellumio Expands to U.S. with Portable Stroke Detection Technology
• Wellumio, a New Zealand-based company, is expanding into the U.S. market to conduct clinical trials for its Axana stroke detection device.
• The Axana device utilizes Pulsed Gradient Free Mapping (PGFM) to rapidly detect stroke biomarkers at the patient's bedside, improving the speed of diagnosis.
• Wellumio has appointed key executives and medical advisors to support its U.S. launch and navigate regulatory pathways with the FDA.
• Clinical trials are underway in Australia, with the first patient enrolled to assess the safety and feasibility of Axana in emergency settings.
Telix's TLX250-CDx (Zircaix) BLA for Kidney Cancer Imaging Gains FDA Priority Review
• Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for TLX250-CDx (Zircaix) for kidney cancer imaging.
• TLX250-CDx is an investigational PET drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC).
• The FDA granted Priority Review and provided a PDUFA date of August 27, 2025, paving the way for a potential U.S. commercial launch in 2025.
• Phase III ZIRCON trial results demonstrated 86% sensitivity, 87% specificity, and 93% positive predictive value for ccRCC across three independent radiology readers.
Large Trial Investigates Perioperative Ketamine for Prevention of Chronic Post-Surgical Pain
• A large, multi-center trial (ROCKet) is underway to assess if intravenous ketamine, administered perioperatively, can reduce chronic post-surgical pain (CPSP) at 3 months post-surgery.
• The trial includes over 4800 adult patients undergoing various major surgeries and compares ketamine infusion to placebo, with CPSP incidence as the primary outcome measure.
• Secondary objectives include evaluating ketamine's impact on acute postoperative pain, side effects, quality of recovery, and CPSP incidence at 12 months post-surgery.
• The study incorporates a rigorous, blinded protocol with continuous safety monitoring and pre-planned statistical analyses to determine ketamine's efficacy in preventing CPSP.
PolyActiva's PA5108 Glaucoma Implant Demonstrates Promising IOP Reduction in Phase 2 Trial
• PolyActiva's PA5108 implant showed significant IOP reduction over 26 weeks in a Phase 2 trial, meeting key efficacy and safety endpoints.
• The implant, designed for sustained latanoprost delivery, addresses patient adherence issues by providing consistent medication over an extended period.
• Clinical trials suggest minimal adverse effects, with no evidence of inflammation or corneal endothelial cell changes observed during the study.
• A Phase 2b study is planned in the US, with Phase 3 trials expected to begin soon, potentially leading to market availability by 2029.
Oral Infigratinib Shows Promise for Children with Achondroplasia
• A phase II study found that oral infigratinib was safe and effective in children with achondroplasia, showing a dose-dependent increase in height velocity.
• The highest dose of infigratinib (0.25 mg/kg) resulted in a mean change from baseline of 2.5 cm per year in annualized height velocity at 18 months.
• Infigratinib offers a potential alternative to the current standard treatment, vosoritide, which requires daily subcutaneous injections.
• A phase 3, double-blind, placebo-controlled trial is underway to further evaluate infigratinib in a larger cohort of children with achondroplasia.
Deferiprone Fails to Improve Cognition in Early Alzheimer's Trial, Raises Concerns
• A clinical trial investigating deferiprone, an iron chelator, in patients with mild cognitive impairment or early Alzheimer's, showed reduced iron levels in the hippocampus but accelerated cognitive decline.
• The 12-month study randomized 81 participants to either deferiprone (15 mg/kg twice daily) or placebo and assessed cognitive function, including memory and executive function.
• While deferiprone effectively lowered iron levels in the hippocampus, patients receiving the drug experienced a worsening of executive function compared to the placebo group.
• Researchers suggest that lowering iron levels with deferiprone may be detrimental for individuals with early Alzheimer's disease, warranting caution in its potential therapeutic use.
Australia Aims to Streamline Clinical Trial Regulations
• Australia is seeking to simplify its clinical trial regulations to enhance efficiency and innovation in medical research.
• The University of Melbourne launched Doherty Clinical Trials, Australia’s first facility dedicated to human challenge trials for vaccine development.
• The initiative addresses the complexities and red tape that can hinder clinical trial progress in the country.
CRISPR-Cas13bt3 System Effectively Silences VEGFA in Retinal Cells
• A CRISPR-Cas13bt3 system, delivered via AAV, significantly reduced VEGFA mRNA and protein expression in human retinal organoids and VEGF-transgenic mouse models.
• Single-cell RNA sequencing confirmed the system's high specificity, effectively reducing VEGFA in retinal pigment epithelium cells with minimal off-target effects.
• Researchers found that multiplexed sgRNA delivery did not significantly enhance VEGFA knockdown efficiency compared to single sgRNA delivery.
• The study, led by researchers from the Centre for Eye Research Australia and the University of Melbourne, highlights the potential of Cas13bt3 for targeted gene therapy in retinal diseases.
John Gorman's Anti-D Breakthrough Eradicates Rh Disease in Developed World
• John Gorman's pioneering work in the 1960s led to the development of RhoGAM, effectively eliminating Rh disease, a once-lethal condition for newborns.
• Australia was the first country to implement a national anti-D program, ensuring widespread access to the treatment for Rh-negative pregnant women.
• Despite its eradication in developed countries, Rh disease remains a significant issue in the developing world, causing an estimated 160,000 fetal and neonatal deaths annually.
• Gorman is now focused on expanding access to anti-D treatment globally through the World Initiative for Rh disease Eradication (WIRhE).
Aumolertinib Extends Progression-Free Survival in Stage III EGFR-Mutated NSCLC
• Aumolertinib maintenance therapy significantly improved progression-free survival compared to placebo in stage III EGFR-mutated NSCLC patients after chemoradiotherapy.
• The POLESTAR study demonstrated a median progression-free survival of 30.4 months with aumolertinib versus 3.8 months with placebo (HR = 0.200, P < .0001).
• Aumolertinib showed a manageable safety profile, with the most common adverse event being an increase in blood creatinine phosphokinase.
• The findings suggest aumolertinib is a novel treatment option for unresectable stage III EGFR-mutated NSCLC after chemoradiotherapy, offering a significant advancement.
Largest Whole-Exome Sequencing Study Uncovers New Genetic Links to Epilepsy Subtypes
• A large-scale whole-exome sequencing study involving 21,000 epilepsy patients and 33,000 controls has identified new genetic links to various epilepsy subtypes.
• The study highlights the significant role of genes encoding ion channels in multiple epilepsy subtypes, including epileptic encephalopathies and generalized and focal epilepsies.
• Researchers found subtype-specific genetic contributions, offering data-driven insights for understanding epilepsy biology and developing tailored diagnostic and treatment approaches.
• The Epi25 Collaborative's findings suggest potential therapeutic targets related to neuronal communication and synaptic transmission, with data accessible via an interactive browser.
Magnesium Sulfate Prevents Cerebral Palsy in Premature Babies: Cochrane Review
• A Cochrane review confirms that magnesium sulfate infusions given to women at risk of premature birth can prevent cerebral palsy in their babies.
• The inexpensive treatment, costing approximately $6.50 per dose, has been recommended by the WHO since 2015 for women at risk of premature birth before 32 weeks.
• A program in England demonstrated that widespread use of magnesium sulfate resulted in an estimated 385 fewer cases of cerebral palsy between 2018 and 2023.
• Researchers call for increased global implementation and further studies to optimize the drug's administration, especially in low-resource settings.
Paternal Use of Valproate Not Linked to Increased Birth Defect Risk, Study Suggests
• A new review suggests that fathers taking the epilepsy drug valproate do not pose a significant risk of birth defects or developmental disorders in their children.
• Researchers found scarce and inconsistent evidence linking paternal exposure to anti-seizure medications, including valproate, to adverse offspring outcomes compared to unexposed controls.
• The study questions regulatory restrictions on valproate use for men, as it may lead to less effective medication choices and increased risks of disease and sudden unexpected death in epilepsy (SUDEP).
• The authors emphasize the need for further research to investigate the potential reproductive implications of anti-seizure medication exposure in males.
Paternal Use of Epilepsy Drug Valproate Not Linked to Increased Birth Defect Risk, Study Finds
• A new study indicates that valproate, an anti-seizure medication, does not pose a significant risk of birth defects or developmental disorders when taken by men planning to father children.
• Researchers found scarce and inconsistent evidence of harm to offspring from paternal exposure to anti-seizure medications, with most studies showing no increased risk compared to unexposed controls.
• The study questions the U.K.'s regulatory restrictions on valproate use for men under 55, suggesting it may lead to less effective treatments and increased risks of seizures and sudden unexpected death in epilepsy (SUDEP).
• Experts emphasize the need for further research but suggest current evidence provides reassuring information regarding the safety of paternal valproate exposure.
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