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Clinical Trial News

OmRx Oncology Launches Phase 2 Trial of Oral Checkpoint Inhibitor OX-4224 for NSCLC

  • OmRx Oncology launched with the goal of increasing access to cancer immunotherapy in low and middle-income countries.
  • OX-4224, an oral PD-1/PD-L1 inhibitor in-licensed from Gilead Sciences, will be evaluated in a Phase 2 trial for NSCLC.
  • The Phase 2 study will be conducted in India, focusing on patients with NSCLC who have not received prior checkpoint inhibitors.
  • OmRx aims to develop OX-4224 as a more affordable and accessible alternative to antibody checkpoint inhibitors.

Sansum Diabetes Research Institute Actively Recruiting Pediatric Patients for Clinical Trials

  • Sansum Diabetes Research Institute (SDRI) is recruiting patients aged 2-17 for pediatric clinical trials focused on diabetes research.
  • Dr. Kristin Castorino and a pediatric clinical trial patient, Aidan Free, discussed the trials and their importance.
  • The clinical trials aim to advance understanding and treatment of diabetes in young patients.
  • Interested individuals can find more information and participate through the Sansum Diabetes Research Institute website.

Oxford Heartbeat Completes Patient Recruitment for AI-Powered PreSize Neurovascular Software Trial

  • Oxford Heartbeat has concluded patient recruitment for its clinical trial of PreSize Neurovascular, an AI-powered software designed to aid in neurovascular surgery.
  • The trial, funded by the UK's NIHR, is a multicenter, prospective study run by Imperial Clinical Trials Unit, involving 100 patients with cerebral aneurysms.
  • PreSize software aims to optimize the selection of flow-diverting stents, potentially reducing device wastage, improving surgical efficiency, and minimizing patient complications.
  • The trial compares clinical decision-making with and without PreSize, assessing surgical efficiency metrics to demonstrate the software's benefits in real-world settings.

CDC Recommends 21-Valent Pneumococcal Conjugate Vaccine (PCV21) for Adults

  • The CDC recommends the 21-valent pneumococcal conjugate vaccine (PCV21) for adults, particularly those at higher risk of pneumococcal disease, to broaden protection against invasive strains.
  • Clinical trials demonstrate PCV21's non-inferior immunogenicity compared to existing vaccines like PCV15, PCV20, and PPSV23, with statistically significant improvements against unique serotypes.
  • Safety data from trials indicate that PCV21 has a similar safety profile to comparator vaccines, with mostly mild to moderate adverse events like injection site pain and fatigue.
  • Economic models suggest PCV21's cost-effectiveness varies, potentially being cost-saving compared to PCV20 in high-risk groups, but less favorable for universal vaccination in younger adults.

B Cell Abnormalities Predict Treatment Response in Triple-Negative Breast Cancer

  • Researchers identified two distinct patterns of B cell abnormalities in triple-negative breast cancer patients that correlate with treatment response.
  • Patients with TiBA-0 B cell profiles showed a 78.6% complete response rate to chemotherapy and immunotherapy, compared to 33.3% in TiBA-1 and TiBA-2 groups.
  • The study suggests that B cell changes, detectable via blood draw, could serve as biomarkers to stratify patients for treatment strategies.
  • Future research will focus on validating these biomarkers in larger cohorts and exploring methods to reverse tumor-induced changes in bone marrow.

FDA Approves Over-the-Counter Hearing Aid Software for Apple AirPods Pro

  • The FDA has approved the first over-the-counter (OTC) hearing aid software, the Hearing Aid Feature (HAF), for use with Apple AirPods Pro.
  • HAF is designed for adults 18 and older with perceived mild to moderate hearing impairment, allowing personalized sound amplification.
  • Clinical studies showed HAF's self-fitting strategy provides similar benefits to professional fitting, enhancing accessibility to hearing support.
  • This authorization follows the FDA's 2022 OTC hearing aid regulations, expanding access to hearing aids without prescriptions or audiologist visits.

Yunu Provides Free Platform Access for Children's Oncology Group Clinical Trials

  • Yunu is extending free use of its clinical trial imaging platform to all Children's Oncology Group (COG) clinical trials nationwide, aiming to improve pediatric cancer care.
  • The initiative waives implementation and platform time-point fees for COG trials at collaborating sites with a Yunu subscription, enhancing access to advanced imaging.
  • Yunu's platform reduces research coordinator time by 80% and radiologist time by 50% on imaging assessments, while also minimizing clinical trial imaging data error rates.
  • This commitment aims to support institutions serving underserved and rare pediatric disease populations, ensuring accurate and timely imaging data for treatment decisions.

GSK and CureVac Announce Positive Phase 2 Data for mRNA Seasonal Influenza Vaccine

  • GSK and CureVac's mRNA-based seasonal influenza vaccine program has demonstrated positive Phase 2 results, marking a significant step in novel vaccine development.
  • The vaccine showed an improved immune response compared to existing commercial vaccines, suggesting enhanced protection against influenza strains.
  • This collaboration leverages mRNA technology to potentially offer more effective and adaptable influenza vaccines, addressing a critical public health need.
  • Further clinical trials are planned to assess long-term efficacy and safety, paving the way for potential regulatory submissions.

Medtronic Gains FDA Approvals for Percept and Inceptiv Systems

  • Medtronic's Percept system, a 'pacemaker for the brain,' received FDA approval for managing movement disorders like Parkinson's disease by sending electrical signals to modulate brain rhythms.
  • The Inceptiv spinal cord stimulator, designed for chronic pain treatment, secured FDA approval with its unique ability to automatically adjust therapy, enhancing pain relief and maintaining stimulation levels.
  • Clinical data suggests that a significant percentage of patients undergoing spine operations continue to experience spinal pain, highlighting the need for innovative solutions like Inceptiv.
  • Analysts anticipate growth for Medtronic due to the launch of the Inceptiv closed-loop spinal cord stimulator, praising its potential impact on the neuromodulation market.

Hypofractionated Radiation Therapy Improves Outcomes in Breast Cancer Patients

  • A systematic review and meta-analysis indicates that moderate hypofractionation reduces acute radiation dermatitis by 46% in breast conserving therapy patients and 32% in mastectomy patients compared to conventional fractionation.
  • Moderate hypofractionation is associated with less hyperpigmentation and breast shrinkage, as well as improved cosmesis and quality of life, compared to conventional fractionation.
  • Survival and recurrence rates were similar across ultra-hypofractionation, moderate hypofractionation, and conventional fractionation, suggesting shorter radiation protocols should be considered the standard approach.
  • The study suggests shorter radiation protocols enhance patient convenience and are potentially more cost-effective, while longer-course regimens should be reserved for selected cases.

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