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HiDO Technologies Secures NIA Grant to Advance AI Dementia Care

  • HiDO Technologies has been awarded a Phase II SBIR grant from the National Institute on Aging (NIA) to further develop its AI-driven dementia care technology.
  • The technology leverages facial recognition and video observation to enhance safety, improve health outcomes, and alleviate caregiver stress for dementia patients.
  • The grant will enable HiDO Technologies to accelerate the development and deployment of its innovative solutions for individuals living with dementia.
  • HiDO Technologies focuses on creating AI-driven solutions to improve care for people with chronic health conditions, including dementia.

BioStem Technologies Initiates Clinical Trial of BR-AC for Diabetic Foot Ulcers

  • BioStem Technologies has begun the BR-AC-DFU-101 clinical trial to assess BR-AC (BioREtain - Amnion Chorion) for treating non-healing diabetic foot ulcers (DFUs).
  • The study will enroll 60 patients across 10 U.S. sites, comparing BR-AC plus standard care to standard care alone, with completion expected by the end of 2025.
  • The primary goal is to determine if BR-AC enhances complete wound closure within 12 weeks, with secondary outcomes including closure time and wound area changes.
  • DFUs affect 15% of diabetic individuals, leading to significant hospitalization and amputation risks, with treatment costs in the U.S. ranging from $9 to $13 billion annually.

A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC

NCT06511596Active, Not RecruitingNot Applicable
BioStem Technologies
Posted 9/3/2024

Emergex's T Cell Vaccine Selected for NIH's Project NextGen Clinical Trials

  • Emergex's CoronaTcP, a T cell-priming vaccine candidate, has been chosen by the NIH/NIAID for clinical trials under Project NextGen, aimed at developing next-generation COVID-19 vaccines.
  • The vaccine has demonstrated a favorable safety profile and the ability to elicit targeted CD8+ T cell immune memory, crucial for long-lasting protection against Betacoronaviruses.
  • Project NextGen will cover the full cost of the Phase I clinical trial, with Emergex responsible for providing clinical trial materials and documentation.
  • CoronaTcP is designed to be broadly effective against Betacoronavirus infections, including SARS-CoV-1 and SARS-CoV-2 variants, potentially reducing the need for frequent boosters.

A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against SARS-CoV-2

NCT05113862CompletedPhase 1
Gylden Pharma Ltd
Posted 1/10/2022

Antibody-Based Test Shows Promise for Early Melanoma Detection

  • Australian researchers have identified circulating antibodies against tumor antigens as potential biomarkers for early melanoma detection, offering a more accurate diagnosis.
  • A novel cancer-specific array, tested on plasma samples from stage I and II melanoma patients, highlighted three tumor antigens with high accuracy in early-stage melanoma diagnosis.
  • The biomarker with an AUC of 0.981 demonstrated 98% sensitivity in the discovery cohort and 99% in the validation cohort, with specificity at 82%.
  • Researchers are also developing a multimodal AI-based approach integrating imaging, pathology, and antibody profiling data to improve melanoma diagnosis accuracy.

Apalutamide Demonstrates Superior Overall Survival Compared to Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer

  • A retrospective analysis reveals apalutamide significantly improves overall survival (OS) compared to enzalutamide in metastatic castration-sensitive prostate cancer (mCSPC) patients.
  • At 24 months, apalutamide showed a 23% reduction in the risk of death versus enzalutamide (HR, 0.77; 95% CI, 0.62-0.96; P = .019).
  • The survival benefit with apalutamide aligns with findings from the phase 3 TITAN trial, reinforcing its efficacy in mCSPC treatment.
  • This real-world evidence supports apalutamide as a valuable option for prescribers choosing an androgen receptor pathway inhibitor (ARPI).

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

NCT02489318Active, Not RecruitingPhase 3
Aragon Pharmaceuticals, Inc.
Posted 11/27/2015

Low-Dose Decitabine Shows Promise in Myelofibrosis Treatment

  • A phase II trial of low-dose subcutaneous decitabine demonstrated a 33% overall response rate in myelofibrosis (MF) patients, primarily improving cytopenias.
  • The treatment showed a median response duration of 7 months and a favorable safety profile with manageable non-hematologic toxicities.
  • Decitabine may offer a new therapeutic avenue for MF patients, who currently have limited treatment options beyond symptom palliation.
  • The study supports further investigation of hypomethylating agents like decitabine, alone or in combination, for treating myelofibrosis.

Decitabine in Treating Patients With Myelofibrosis

NCT00095784Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 9/29/2004

Conformal Medical Initiates GLACE Study for Next-Gen LAAO Device with ICE Imaging

  • Conformal Medical has begun its GLACE study to assess the use of intracardiac echocardiography (ICE) imaging during left atrial appendage occlusion (LAAO) procedures using the CLAAS AcuForm device.
  • The GLACE study aims to enroll approximately 80 patients across multiple European sites to validate the use of ICE with the innovative LAAO technology in patients with non-valvular AFib.
  • The CLAAS AcuForm LAAO system is designed to conform and seal the LAA, simplifying delivery and potentially eliminating the need for general anesthesia during the procedure.
  • ICE imaging offers real-time visualization, enhancing precision and potentially reducing radiation exposure and procedure time during LAAO closure.

BioIntelliSense's BioButton Receives FDA Clearance for Continuous Patient Monitoring

  • BioIntelliSense gains FDA clearance for its rechargeable BioButton wearable and BioDashboard system, enhancing continuous patient monitoring in hospitals and at home.
  • The BioButton automates vital sign collection, reducing manual tasks and improving clinical workflow efficiencies across various healthcare settings.
  • BioDashboard offers data-driven exception management, enabling clinicians to monitor numerous patients concurrently and make proactive clinical decisions.
  • The system aims to improve patient safety, prioritize care, and make continuous care more affordable and accessible for all hospital-admitted patients.

Malignant Serous Effusions Offer Molecular Insights for Precision Oncology

  • A prospective study analyzed malignant serous effusions (MSEs) from 184 patients to understand the molecular landscape and drug responses for precision oncology.
  • The study integrated genomic, transcriptomic, and proteomic data from MSEs to identify potential therapeutic targets and predict drug sensitivities.
  • Ex vivo drug screening (pharmacoscopy) was performed on MSE-derived cells to quantify cellular composition and drug responses, revealing personalized therapeutic strategies.
  • Multi-omics factor analysis identified disease-specific factors and potential therapeutic targets, offering insights into patient-specific drug responses.

Real-World Data Show Less Robust Weight Loss with GLP-1 Drugs Compared to Clinical Trials

• Real-world studies indicate that weight loss from GLP-1 agonists is less pronounced than reported in clinical trials, with patients achieving only a 3.7% average weight loss after one year. • Patient persistence with GLP-1s is a significant challenge, as discontinuation rates can reach as high as 85% after two years of treatment, impacting long-term health outcomes. • Factors such as medication supply shortages, adverse effects, high costs, and unmet expectations contribute to non-persistence in real-world GLP-1 usage. • To achieve the health benefits of GLP-1s, sustained use is crucial to realize clinical success and avoid potential weight regain after discontinuing the medication.

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