Clinical Trial News
Brain-Controlled Bionic Leg Improves Mobility for Amputees in Clinical Trial
- A novel brain-controlled bionic leg enables amputees to control prosthetic movements with their thoughts, leading to a more natural gait.
- Clinical trial participants experienced a 41% increase in walking speed and improved stability on stairs and uneven terrain compared to traditional prosthetics.
- The bionic leg utilizes a new surgical approach, agonist-antagonist myoneural interface (AMI), preserving muscle connections for enhanced control and reduced pain.
- Researchers aim to commercialize the technology within five years, potentially revolutionizing care for amputees worldwide.
Improving Clinical Trial Informed Consent: New Strategies to Enhance Patient Understanding and Trial Success
- Studies reveal concerning gaps in clinical trial consent comprehension, with only 52-53% of participants understanding crucial concepts like placebo use and randomization.
- The i-CONSENT project has released validated recommendations for enhancing informed consent processes, emphasizing patient-centered communication and adaptive information delivery methods.
- Poor consent comprehension poses significant risks to trial success, potentially leading to reduced participant diversity, lower compliance rates, and increased dropout rates, ultimately compromising research quality.
Ivabradine's Impact on Heart Failure with Reduced Ejection Fraction: A Systematic Review and Meta-Analysis
A comprehensive review and meta-analysis reveal that Ivabradine significantly reduces the risk of heart failure mortality and hospitalization in patients with heart failure reduced ejection fraction (HFrEF), while also improving left ventricular ejection fraction and reducing resting heart rate. However, it is associated with an increased risk of both symptomatic and asymptomatic bradycardia.
Lynparza and Imfinzi Combination Recommended for EU Approval in Endometrial Cancer Treatment
AstraZeneca's Imfinzi and Lynparza have received a positive recommendation from the European Medicines Agency for treating certain endometrial cancer patients, marking a significant advancement in cancer care.
Long-Term Biologic Therapy Shows Sustained Efficacy in Chronic Rhinosinusitis with Nasal Polyps
- A 4-year study confirms the sustained efficacy and tolerability of biologics like Dupilumab, Mepolizumab, and Omalizumab for treating chronic rhinosinusitis with nasal polyps (CRSwNP).
- Significant improvements were observed in nasal polyp score, olfaction, and quality of life, with many patients reducing their reliance on oral steroids and surgery.
- Biologic switching was well-tolerated and effective for patients experiencing inadequate response or intolerable side effects, offering a viable alternative.
- The therapy also positively impacted associated Th2 comorbidities like asthma and allergic rhinitis, highlighting the systemic benefits of biologic interventions.
Nivolumab Plus Ipilimumab Improves Quality of Life in MSI-H/dMMR Metastatic Colorectal Cancer
- Frontline nivolumab plus ipilimumab significantly reduces the risk of health-related quality of life deterioration in patients with MSI-H/dMMR metastatic colorectal cancer.
- The combination therapy showed clinically meaningful improvements in global health status compared to chemotherapy, surpassing the minimally important difference threshold.
- Patients receiving nivolumab/ipilimumab experienced improvements in physical, role, and social functioning, along with reduced severity of fatigue, nausea, vomiting, and pain.
- The CheckMate 8HW trial supports the use of first-line nivolumab and ipilimumab in MSI-H/dMMR metastatic CRC, demonstrating superior progression-free survival and enhanced quality of life.
Highlighted Clinical Trials:
Bristol-Myers Squibb
Posted 8/5/2019
KaliVir's Oncolytic Immunotherapy VET3-TGI Receives FDA IND Clearance for Solid Tumor Trial
- KaliVir Immunotherapeutics received FDA clearance for its IND application for VET3-TGI, an oncolytic immunotherapy, to treat advanced solid tumors.
- The Phase 1/1b study (STEALTH-001) will assess VET3-TGI's safety and efficacy as a monotherapy and in combination with checkpoint inhibitors.
- VET3-TGI targets and kills tumor cells while stimulating anti-cancer immunity through interleukin-12 and TGFbeta inhibitor expression.
- This trial marks KaliVir's second clinical trial initiation from its VET platform, following progress with ASP1012 licensed to Astellas.
Highlighted Clinical Trials:
KaliVir Immunotherapeutics
Posted 9/16/2024
Kashiv BioSciences and Amneal Pharmaceuticals Partner for Omalizumab Biosimilar
- Kashiv BioSciences has entered an exclusive licensing agreement with Amneal Pharmaceuticals for ADL018, a biosimilar to omalizumab (XOLAIR®), for the U.S. market.
- ADL018, currently in Phase III clinical trials, targets free IgE and is intended for conditions like allergic asthma and chronic rhinosinusitis with nasal polyps.
- This partnership builds on the existing collaboration between Kashiv and Amneal, following the successful U.S. biosimilar launches of RELEUKO® and FYLNETRA®.
- Omalizumab (XOLAIR®) had approximately $3.2 billion in U.S. sales for the 12 months ending April 2024, according to IQVIA®.
FDA Approves Tepylute, a Ready-to-Dilute Thiotepa Formulation, for Breast and Ovarian Cancer
- The FDA has approved Tepylute, a ready-to-dilute formulation of thiotepa, for treating breast and ovarian cancer, addressing limitations of the previous powder form.
- Tepylute simplifies drug preparation, enhances dosing accuracy, and reduces healthcare personnel's exposure to this hazardous drug during handling.
- Developed by Shorla Oncology, Tepylute is their first in-house NDA approval, marking a significant advancement in their oncology drug pipeline.
- The new formulation aims to improve efficiency and safety in clinical settings, offering a more convenient option for clinicians and patients.
Infection Risk With BTK Inhibitors Low, New CLL Study Finds
A recent study on chronic lymphocytic leukemia (CLL) patients using Bruton’s tyrosine kinase (BTK) inhibitors shows a minimal increase in the risk of invasive fungal infections, with a 1% higher risk compared to those not using BTK inhibitors. The study, published in Open Forum Infectious Diseases, emphasizes the need for further research to identify high-risk patient groups and effective prevention interventions.