Scientific Breakthrough Reveals How Alpha1H Targets Bladder Cancer Cells
• Hamlet BioPharma and Lund University researchers have discovered that Alpha1H, a bladder cancer drug candidate, targets the endoplasmic reticulum in tumor cells, causing it to collapse like a net around toxic components.
• The mechanism explains Alpha1H's ability to kill cancer cells while sparing healthy tissue, as it prevents leakage of harmful substances from dying tumor cells into surrounding areas.
• This breakthrough provides scientific validation for Alpha1H's efficacy and safety profile, strengthening its market position and potential applications in treating the 600,000 people affected by bladder cancer annually.
Targeted Radiopharmaceuticals Summit Returns to Europe and US as Industry Momentum Builds
• The 6th Targeted Radiopharmaceuticals Summit Europe will take place in Amsterdam on December 3-5, featuring 40+ speakers across pre-clinical and clinical tracks as radiopharmaceutical innovation accelerates.
• Major pharmaceutical companies including Novartis, Eli Lilly, AstraZeneca, and Bayer are driving industry growth through billion-dollar collaborations and clinical advancements in novel radiopharmaceutical targets.
• The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego in July, bringing together 275+ global stakeholders to address key challenges in isotope supply, manufacturing, and clinical translation.
Concussions in Hockey Players Linked to Doubled Risk of Depression and Tripled Risk of Burnout
• Hockey players who suffered three or more concussions had twice the risk of depression symptoms compared to those without concussion history, according to new Swedish research.
• The study revealed concussed athletes faced 3.5 times higher risk of burnout symptoms including exhaustion, stress, concentration difficulties, and sleep disturbances.
• Both male and female hockey players showed equally strong links between concussion and mental health issues, challenging previous assumptions about gender differences in recovery.
Early Combination of Statins and Ezetimibe Could Prevent Thousands of Heart Attacks, Study Finds
• Researchers from Imperial College London and Lund University found that early combination therapy with statins and ezetimibe significantly reduces the risk of subsequent heart attacks and death in cardiac patients.
• The study analyzed data from 36,000 heart attack patients, revealing that those receiving combination treatment within 12 weeks had better outcomes than patients receiving delayed treatment or statins alone.
• Implementation of early combination therapy could prevent an estimated 133 heart attacks per 10,000 patients over three years, potentially saving 5,000 heart attacks in the UK over a decade.
Cantargia Initiates First Clinical Trial of Nadunolimab for AML and MDS Treatment
• Swedish biotech Cantargia has enrolled the first patient in a Phase Ib/IIa trial investigating nadunolimab in combination with standard chemotherapy for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
• The US Department of Defense-funded study aims to enroll 40 patients and will assess safety, dosing recommendations, and efficacy measures including overall response rates and duration of response, with full recruitment expected by 2027.
• This marks nadunolimab's first application in hematological malignancies, building on promising results in solid tumors and leveraging the discovery that leukemia stem cells express IL1RAP, the antibody's target protein.
Aspirin Reduces Colorectal Cancer Recurrence in PI3K-Mutated Tumors
• A daily 160mg dose of aspirin significantly reduces the risk of colorectal cancer recurrence in patients with PI3K mutations.
• The ALASCCA trial demonstrated a 51% to 58% reduction in recurrence risk in patients with specific PI3K pathway alterations.
• The study highlights the potential for repurposing aspirin as a cost-effective adjuvant therapy and emphasizes the importance of genomic testing.
• While aspirin was generally safe, the study reported a slightly higher incidence of adverse events compared to placebo.
OncoAssure's Novel Prostate Cancer Test Achieves Clinical Validation, US Launch Planned for Q1 2025
OncoAssure Ltd has announced clinical validation of their innovative prostate cancer biopsy test that improves risk assessment for cancer recurrence. The test, validated through a multi-institutional study, demonstrates enhanced ability to differentiate between aggressive and low-risk prostate cancers, addressing a critical need in treatment decision-making.
BlueRock Therapeutics' Bemdaneprocel Advances to Phase 3 for Parkinson's Disease
• BlueRock Therapeutics is initiating a Phase 3 trial, exPDite-2, for bemdaneprocel, a cell therapy for Parkinson's disease, expected to begin in the first half of 2025.
• The exPDite-2 trial will enroll 102 patients with moderate Parkinson's, assessing the change in 'on' time without dyskinesia over 78 weeks compared to a sham surgery.
• Bemdaneprocel aims to replace dopamine-producing neurons lost in Parkinson's, with Phase 1 data showing tolerability and encouraging trends in motor function.
• The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation, potentially accelerating its development and review process.
Study Reveals Critical Gaps in UK's Pharma-Doctor Payment Disclosure System
• New research from University of Bath and Lund University exposes significant transparency issues in the UK's voluntary pharmaceutical payment disclosure system, with £3.3 billion in research payments lacking recipient details.
• Study finds major pharmaceutical companies, including AstraZeneca and Bristol Myers Squibb, classify over 90% of healthcare professional payments as research-related, potentially obscuring financial relationships.
• Researchers advocate for legislation similar to the US Sunshine Act to replace the current self-regulated Disclosure UK system, emphasizing the need for stronger transparency measures.
Stem Cell Therapies Show Promise in Clinical Trials for Parkinson's, Epilepsy, and Diabetes
• Clinical trials are exploring stem cell therapies to replace or supplement tissues in diseases like cancer, diabetes, and Parkinson's, differing from unapproved treatments.
• Parkinson's disease trials using dopamine-producing cells derived from stem cells have shown safety and hints of efficacy, with no uncontrolled movement side effects reported.
• A clinical trial for epilepsy using transplanted interneurons has significantly reduced seizure frequency in participants, leading to FDA fast-track status.
• Vertex Pharmaceuticals' trial for type 1 diabetes using stem cell-derived islet cells has shown promising early results, with some participants no longer needing insulin injections.
AI-Powered Breast Cancer Detection Gains FDA Clearance for Expanded Mammography System Compatibility
• SmartMammo Dx, an AI algorithm by DeepHealth, secured FDA clearance for use with GE HealthCare's Senographe Pristina mammography systems.
• Transpara 2.1, ScreenPoint Medical's Breast AI, obtained FDA clearance for breast density assessment and temporal comparison, improving cancer detection.
• Studies show Transpara increases cancer detection rates, reduces radiologist workload, and performs well in dense and non-dense breasts.
SBRT Shows Non-Inferiority to Standard Radiotherapy in Localized Prostate Cancer
• A phase 3 trial, PACE-B, reveals that five-fraction stereotactic body radiotherapy (SBRT) is non-inferior to conventional radiotherapy for low- to intermediate-risk localized prostate cancer.
• The 5-year incidence of freedom from biochemical or clinical failure was 95.8% in the SBRT group and 94.6% in the control group, indicating comparable cancer control outcomes.
• SBRT offers a reduced treatment duration, potentially alleviating the burden on healthcare systems while maintaining favorable cancer control without hormonal treatment.
• While genitourinary adverse effects were slightly higher in the SBRT group, the overall safety profile was acceptable, supporting SBRT as a viable alternative to standard radiotherapy.
Hamlet BioPharma Reports Positive Clinical Progress in Q1 2024-2025
• Hamlet BioPharma's Q1 report highlights significant clinical advancements in bladder cancer, recurrent acute cystitis, and bladder pain treatments.
• Phase II trials of Alpha1H show strong clinical tumor response in bladder cancer patients, with publication in *Cancer Medicine*.
• Immunotherapy with anakinra demonstrates comparable efficacy to antibiotics in treating recurrent bacterial urinary tract infections.
• The company is advancing new drug candidates and exploring strategic alliances for cancer and immunotherapy projects.
PrecivityAD2 Blood Test Enhances Alzheimer's Diagnosis and Treatment Decisions
• The PrecivityAD2 blood test significantly improves diagnostic confidence for Alzheimer's disease, increasing it from 50-60% to over 90% among clinicians.
• Clinical integration of the PrecivityAD2 test leads to a 35% increase in prescriptions for Alzheimer's disease medications for patients with positive results.
• The test demonstrates high concordance (99%) with intended clinical use and maintains a diagnostic accuracy of 90% when compared to cerebrospinal fluid analysis.
• PrecivityAD2's Amyloid Probability Score 2 (APS2) effectively differentiates Alzheimer's disease pathology, aiding in more accurate diagnosis and treatment planning.
Hamlet BioPharma's Alpha1H Receives FDA Fast Track for Bladder Cancer Treatment
• Hamlet BioPharma's Alpha1H, a tumor-killing compound, has received Fast Track designation from the FDA for bladder cancer treatment, expediting its development.
• Phase II trials of Alpha1H have demonstrated promising results in selectively destroying bladder cancer cells via apoptosis without harming healthy tissues.
• Immunotherapy using anakinra (IL-1RA) shows positive Phase II results for recurrent acute cystitis and severe bladder pain, potentially reducing antibiotic use.
• Hamlet BioPharma is advancing Alpha1H to Phase III studies and exploring partnerships to bring innovative treatments to market, addressing unmet medical needs.
Elixir Medical's DynamX Bioadaptor Meets Primary Endpoint in INFINITY-SWEDEHEART Trial
• The INFINITY-SWEDEHEART trial met its primary endpoint, demonstrating non-inferiority of Elixir Medical's DynamX bioadaptor compared to Resolute Onyx DES for target lesion failure (TLF) at 12 months.
• A pre-specified landmark analysis revealed a statistically significant reduction in TLF with DynamX compared to DES after six months, indicating improved long-term outcomes.
• The DynamX bioadaptor showed numerically lower adverse events across components of the composite endpoint, including target vessel myocardial infarction and ischemia-driven target lesion revascularization.
• The study supports the clinical impact of the Bioadaptor in coronary artery disease treatment, potentially reducing recurring adverse events after percutaneous coronary intervention.
AI Shows Promise in Predicting and Personalizing Treatment for Type 1 Diabetes
• A new article in Diabetologia highlights the potential of artificial intelligence (AI) in identifying and stratifying individuals at risk of type 1 diabetes.
• AI can analyze extensive data repositories to refine screening strategies and enhance early detection and preventive care for type 1 diabetes.
• The ASSET consortium is developing AI algorithms to assess individual risk and predict treatment response, utilizing data from studies like TEDDY and Diamyd Medical's trials.
• AI's ability to personalize preventive treatments is crucial, given the highly individual progression of type 1 diabetes, potentially revolutionizing screening and treatment approaches.
© Copyright 2025. All Rights Reserved by MedPath