The Governors of the University of Calgary
🇨🇦Canada
- Country
- 🇨🇦Canada
- Ownership
- Private
- Established
- 1966-04-29
- Employees
- 1K
- Market Cap
- -
- Website
- http://www.ucalgary.ca
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.
Probiotic Supplementation Reduces Mortality in Preterm Infants, Canadian Study Shows
• A large Canadian retrospective study of 32,667 preterm infants reveals probiotics significantly reduced mortality rates, with an adjusted odds ratio of 0.62 in infants born before 34 weeks gestation.
• While probiotics showed promising survival benefits, they did not significantly decrease rates of necrotizing enterocolitis or late-onset sepsis, two common complications in preterm infants.
• The study found probiotic sepsis was rare, occurring in only 27 infants, though researchers emphasize the need for pharmaceutical-grade products and further research on specific probiotic strains.
ESCAPE-MeVO Trial: Endovascular Thrombectomy Shows No Added Benefit for Medium Vessel Occlusion Stroke
• Late-breaking ESCAPE-MeVO trial results reveal endovascular thrombectomy combined with best medical care offers no additional benefit over best medical care alone for medium-vessel occlusion stroke patients.
• Study of 530 patients shows comparable primary outcomes at 90 days, with the combination therapy group showing higher mortality rates (13.3% vs 8.4%) and increased serious adverse events.
• Findings published in the New England Journal of Medicine raise important questions about optimal treatment approaches for medium vessel occlusions and appropriate outcome measures for mild deficit patients.
Brain Stimulation Shows No Added Benefit for Post-Stroke Motor Recovery in Phase 2 TRANSPORT 2 Trial
• A Phase 2 multicenter trial found that transcranial direct current stimulation (tDCS) failed to enhance motor recovery when combined with constraint-induced movement therapy in post-stroke patients.
• The TRANSPORT 2 study, involving 129 patients across 15 U.S. medical centers, demonstrated that both high-dose (4mA) and low-dose (2mA) stimulation groups showed no significant advantage over sham treatment.
• Despite neutral efficacy results, researchers confirmed the safety and feasibility of tDCS in stroke rehabilitation, with plans to explore higher doses and improved trial design in future studies.
University of Calgary Launches Validation Study for Advanced At-Home Hormone Monitoring Device
• University of Calgary researchers are initiating a validation study for the Mira Hormone Monitor, a device claiming to provide precise numerical readings of hormone biomarkers from urine samples.
• The study, requiring Health Canada clearance, aims to validate the device's claimed 99% lab-grade accuracy using ultrasound testing as the gold standard for comparison.
• The technology could revolutionize women's healthcare by enabling daily hormone tracking for conditions like PCOS and PMS, while providing comprehensive data for healthcare providers.
Fluid Biomed Secures $27 Million to Advance Bioabsorbable Stent for Brain Aneurysms
• Fluid Biomed closed a $27 million Series A funding round to advance its bioabsorbable stent for treating brain aneurysms, offering a potential alternative to permanent metal stents.
• The polymer-based stent is designed to dissolve over time, reducing risks associated with long-term blood thinner use and interference with CT and MRI scans.
• Clinical trials are planned for Europe in 2025, with the aim of conducting larger patient trials in the US and Canada to secure regulatory approval for the innovative device.
• The funding round was co-led by Amplitude Ventures and a strategic medical investor, with participation from LifeArc Ventures and IAG Capital Partners.
Simon Two-Stage Design Shows Promise for Streamlining Parkinson's Disease Trials
• Analysis of two clinical trials suggests the Simon 2-Stage futility design is feasible for evaluating treatments in early Parkinson's disease, potentially accelerating drug discovery.
• The Simon 2-Stage design allows for earlier stopping points based on interim analysis, saving time and resources in identifying effective therapies.
• Researchers propose using a five-point worsening on the UPDRS motor score as the primary outcome measure with a 12-month follow-up period in such trials.
• The analysis indicates that smaller clinical trials (fewer than 200 participants) using this methodology are feasible, reducing the need for larger, costly RCTs.
Strategic Funding and Collaboration Boost Pediatric Brain Cancer Clinical Trials
• Collaborative efforts between the Australian Brain Cancer Mission (ABCM) and ANZCHOG are expanding clinical trial access for pediatric brain cancer patients.
• Focused funding models and international partnerships are addressing the challenges of rare diagnoses and complex trial execution.
• Clinical trials are testing innovative treatments to improve survival rates, cognitive benefits, and quality of life for young cancer survivors.
• Sustained investment and innovative funding models are crucial for maintaining momentum and meeting community expectations for accessible trials.
Iqirvo (Elafibranor) Shows Sustained Efficacy and Safety in Long-Term PBC Treatment
• Interim data from the open-label extension of the Phase III ELATIVE trial demonstrate Iqirvo's sustained efficacy and safety profile for up to three years in patients with primary biliary cholangitis (PBC).
• Patients treated with Iqirvo experienced improvements in pruritus and stabilization of surrogate markers of liver fibrosis, suggesting a positive impact on disease progression.
• Exploratory endpoints revealed that Iqirvo led to improvements in fatigue and sleep, as reported by patients, highlighting its potential to address key symptoms of PBC.
• The safety profile of Iqirvo remained consistent with previous findings, with no new safety concerns identified during the extended treatment period.
Ipsen's Iqirvo (elafibranor) Shows Sustained Efficacy and Safety in Long-Term PBC Treatment
• Interim analysis of the Phase III ELATIVE study's open-label extension shows Iqirvo (elafibranor) maintains efficacy and safety for up to three years in PBC patients.
• Patients treated with Iqirvo experienced sustained improvements in pruritus and stabilization of surrogate markers of liver fibrosis over the three-year period.
• Exploratory endpoints revealed improvements in fatigue and sleep, as reported by patients, highlighting the potential for enhanced quality of life.
• The ongoing confirmatory study (NCT06016842) aims to further verify the clinical benefits of Iqirvo in treating primary biliary cholangitis.
FDA Expands Asciminib Indication, Concerns Arise Over Accelerated Approvals
• The FDA has expanded the indications for asciminib (Scemblix) through accelerated approval for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.
• Recent market withdrawals of drugs approved via the FDA's accelerated approval pathway have sparked concerns regarding the robustness of the approval process.
• A phase II/III trial of uproleselan plus cytarabine/daunorubicin in acute myeloid leukemia failed to meet its primary endpoint of event-free survival.
• New data questions the anticancer activity of metformin, a drug commonly used to treat diabetes.
J&J's Tremfya and Lilly's Omvoh Demonstrate Efficacy in Crohn's Disease Phase III Trials
• Johnson & Johnson's Tremfya (guselkumab) showed significant clinical remission in Crohn's disease patients, with up to 66.1% achieving remission at 48 weeks in the GRAVITI study.
• Eli Lilly's Omvoh (mirikizumab) demonstrated high rates of clinical and endoscopic remission in Crohn's disease patients after three years of treatment in the VIVID-2 trial.
• Both Tremfya and Omvoh, interleukin-23 (IL-23) inhibitors, have applications submitted to the FDA for Crohn's disease, potentially offering new treatment options.
• While both drugs show promise, GlobalData predicts Tremfya to have significantly higher sales than Omvoh by 2030, reaching $8.4 billion compared to $867 million.
IL-23 Inhibitors from J&J and Lilly Show Efficacy in Crohn's Disease Trials
• Johnson & Johnson's Tremfya demonstrated significant clinical and endoscopic remission in Crohn's disease patients compared to placebo at 48 weeks.
• Eli Lilly's Omvoh showed high rates of clinical and endoscopic remission in ulcerative colitis patients after two years of treatment in the LUCENT-3 trial.
• In the VIVID-2 trial, Omvoh maintained clinical and endoscopic remission in Crohn's patients over three years, highlighting its long-term efficacy.
• Both Tremfya and Omvoh have applications submitted to the FDA for Crohn's disease, potentially expanding treatment options for this condition.
Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis
• A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis.
• The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup.
• Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation.
• The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new treatment option.
GLP-1 Agonists Show Promise in Reducing Opioid Overdose and Alcohol Intoxication
• A recent study suggests that GLP-1 receptor agonists like semaglutide and tirzepatide may reduce the risk of opioid overdose and alcohol intoxication.
• Analysis of over a million patient records revealed a 40% lower rate of opioid overdose and a 50% reduction in alcohol intoxication among those taking GLP-1 agonists.
• Researchers propose that GLP-1 drugs may modulate reward-response pathways in the brain, impacting addictive behaviors.
• Further clinical trials are needed to confirm these findings and explore the potential of GLP-1 agonists in treating substance use disorders.
Talquetamab and Teclistamab Combination Shows Promising Results in Relapsed/Refractory Multiple Myeloma
• Updated results from the Phase 1b RedirecTT-1 study show the combination of talquetamab and teclistamab yields high response rates in relapsed/refractory multiple myeloma patients.
• The bispecific antibody combination demonstrates durable responses and a manageable safety profile, consistent with each agent's monotherapy profile.
• Patients with extramedullary disease, often resistant to standard therapies, also showed meaningful overall response rates and duration of response with the combination.
• The findings support further investigation of talquetamab-based combinations in multiple myeloma treatment, especially for those with limited options.
DAV132 Adsorbent Does Not Interfere with Plasma Concentrations of Key Antibiotics
• A randomized, controlled study (CL-006) found that DAV132, a colon-targeted adsorbent, did not significantly alter plasma concentrations of ceftriaxone, piperacillin, tazobactam, ceftazidime, and avibactam.
• The study involved 148 healthy volunteers who received DAV132 at two different doses (7.5g or 12g) in combination with antibiotics or without antibiotics over 7 days.
• Exploratory analyses suggest DAV132 may protect the intestinal microbiome diversity during antibiotic treatment, warranting further investigation into its potential role in mitigating antibiotic-associated dysbiosis.
• Research in mice suggests DAV132 may enhance the efficacy of anti-PD-1 immunotherapy by modulating the gut microbiota and immune response, offering a potential strategy to overcome resistance.
Crestone's CRS3123 Shows Promise in Phase 2 Trial for C. difficile Infection
• Crestone's CRS3123 demonstrated comparable clinical cure rates to vancomycin in treating _Clostridioides difficile_ infection (CDI) in a Phase 2 trial.
• The study revealed significantly lower CDI recurrence rates with CRS3123 compared to vancomycin at day 40 (4% vs. 23%).
• CRS3123 was well-tolerated, with no serious treatment-emergent adverse events reported during the clinical trial.
• NIAID exercised its option to provide $4.5 million in new funding for microbiome analyses and manufacturing process optimization of CRS3123.
Probenecid Shows Promise in Alleviating Opioid Withdrawal Symptoms in Clinical Trial
• A clinical trial at the University of Calgary is testing probenecid, a gout medication, to alleviate opioid withdrawal symptoms.
• Research indicates probenecid disrupts abnormal brain-spinal cord communication during opioid withdrawal, reducing hyperactivity in the brain's autonomic system center.
• The 12-week randomized control trial is recruiting participants aged 18 and over aiming to taper or stop opioid use.
• Probenecid has demonstrated effectiveness in reducing opioid withdrawal symptoms in rodents, paving the way for human trials.
Psoriasis Drug Ustekinumab Shows Promise in Preserving Insulin Production in Young Type 1 Diabetes Patients
• A clinical trial found that ustekinumab, a drug currently used for psoriasis, preserved insulin production in young type 1 diabetes patients, with C-peptide levels 49% higher after one year compared to placebo.
• Researchers discovered ustekinumab targets a specific subset of immune cells called Th17.1 cells, which make up only 0.1% of blood immune cells but play a key role in destroying insulin-producing cells.
• The treatment could potentially reduce or eliminate the need for insulin injections if administered early enough, with researchers suggesting future trials combining screening and early intervention.
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