Clinical Trial News
Digital Health Measures Gain Traction in Value-Based Healthcare Despite Implementation Challenges
- Digital measures, including physical activity tracking and cognitive decline monitoring, are emerging as valuable tools in value-based healthcare, particularly when combined with traditional clinical measurements.
- Healthcare stakeholders express initial skepticism about standalone digital measurements, but recognize their potential to provide higher resolution data and valuable insights when paired with standard measures.
- The integration of digital measures faces operational challenges, including cost allocation, technology accessibility, and data consistency, while showing promising applications in clinical research and therapeutic development.
Immix Biopharma's NXC-201 CAR-T Therapy Shows Promise in AL Amyloidosis and Multiple Myeloma
- Immix Biopharma's NXC-201, a BCMA-targeted CAR-T cell therapy, demonstrated a 100% overall response rate in relapsed/refractory AL amyloidosis patients in Phase 1/2a trials.
- The FDA has cleared the IND application for NXC-201, enabling U.S. patient dosing and expanding studies of the therapy in relapsed/refractory AL Amyloidosis.
- NXC-201 has also shown a 95% overall response rate in heavily pre-treated relapsed/refractory multiple myeloma patients with a median follow-up of 11.9 months.
- A virtual KOL event will be hosted to discuss NXC-201's potential as a treatment option for relapsed/refractory AL Amyloidosis, featuring experts in the field.
Highlighted Clinical Trials:
Hadassah Medical Organization
Posted 1/1/2021
Nexcella Inc.
Posted 6/5/2024
Final Data from Phase IIa CORIST Part 2 Trial Shows Promising Median Overall Survival of 10.4 Months
The Phase IIa open-label CORIST part 2 trial has reported a median Overall Survival (OS) of 10.4 months for patients with metastatic colorectal cancer (mCRC), significantly higher than historical data. A potential biomarker, unconjugated bilirubin, was identified, indicating a subset of patients with a median OS of 13.4 months. The trial also observed a Clinical Benefit Rate (CBR) of 21% after 16 weeks, with tumor shrinkage in four patients. These findings suggest a promising direction for the treatment of cancer resistant to current therapies.
ProMIS Neurosciences Initiates Phase 1a Clinical Trial for Alzheimer's Disease Treatment
ProMIS Neurosciences has begun dosing subjects in a Phase 1a clinical trial for PMN310, a novel monoclonal antibody targeting toxic amyloid-beta oligomers in Alzheimer's disease, marking a significant step towards developing a new treatment.
Novartis Highlights New Data on Kisqali, Iptacopan, and Scemblix at SABCS and ASH
- Final analysis of the NATALEE trial showed Kisqali (ribociclib) significantly improved invasive disease-free survival in HR+/HER2- early breast cancer patients.
- APPLY-PNH trial data demonstrated iptacopan monotherapy's sustained efficacy and safety in anti-C5-treated PNH patients with persistent anemia over 48 weeks.
- Scemblix (asciminib) showed sustained efficacy and safety after nearly 4 years in CML-CP patients who failed ≥2 prior tyrosine kinase inhibitors.
4DMedical, TrivarX, and Artrya Advance with FDA Clearances and US Partnerships
- 4DMedical's CT LVAS receives FDA clearance, expanding functional lung imaging accessibility in the US after its Australian rollout.
- TrivarX accelerates its Phase 2 study for Major Depressive Episode, aiming to validate its MEB-001 algorithm for screening and diagnosis.
- Artrya partners with Northeast Georgia Health Ventures to validate its Salix Coronary Anatomy platform for detecting coronary artery disease in the US.
Xeltis' aXess Conduit Shows Promising 12-Month Results in Hemodialysis Access
- Xeltis announced positive 12-month data from its first-in-human trial of aXess, a hemodialysis vascular conduit, presented at VEITHsymposium 2023.
- The trial data showed 100% secondary patency and 78% primary assisted patency with no infections observed in 20 patients.
- aXess is designed to create a new, living vessel for hemodialysis access, potentially reducing interventions and infections compared to current standards.
- A pivotal trial is underway, enrolling up to 110 patients across nine EU countries to further evaluate aXess.
Highlighted Clinical Trials:
Xeltis
Posted 6/10/2021
FDA Approves Medtronic's Minimally Invasive Device for Hypertension Treatment
Medtronic plc has received FDA approval for its Symplicity Spyral renal denervation system, a minimally invasive procedure aimed at treating hypertension. This approval marks a significant advancement in hypertension care, offering patients an adjunctive treatment option to manage high blood pressure more effectively.
UK Approves World's First CRISPR Gene Therapy for Sickle Cell Disease and β-Thalassemia
- The UK has made a landmark decision to approve the world's first CRISPR-based gene therapy, developed by Vertex Pharmaceuticals, for treating sickle cell disease and β-thalassemia.
- This one-time treatment offers potential transformation of patient lives by addressing the genetic root cause of these blood disorders, marking a historic milestone in gene editing technology.
- Despite its therapeutic promise, concerns remain about the high cost of the treatment and questions about accessibility for patients in need, particularly in regions with high disease prevalence.
Biocon Biologics Secures UK Approval for Aflibercept Biosimilar YESAFILI, Expanding European Market Access
- Biocon Biologics received MHRA approval for YESAFILI, a biosimilar of aflibercept, for treating multiple retinal conditions in the UK market.
- The approval follows European Commission authorization in September 2023, demonstrating comparable quality, safety, and efficacy to reference product Eylea.
- YESAFILI targets a significant market opportunity with aflibercept generating $790 million in UK sales as of June 2023.
- The biosimilar expands Biocon's ophthalmology portfolio and strengthens its global presence beyond oncology and diabetes therapeutics.