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Clinical Trial News

Alio Launches CAVA Study to Expand Wearable Platform for Chronic Condition Monitoring

  • Alio, Inc. has initiated the CAVA study to broaden the application of its AI-powered wearable technology beyond dialysis patients to those with various chronic conditions.
  • The CAVA study will enroll 300 participants to assess the SmartPatch's ability to non-invasively monitor key health metrics from the calf, such as hemoglobin and potassium levels.
  • The aim is to validate additional body placement locations, potentially extending the platform's reach to patients without vascular access sites and improving chronic disease management.
  • Alio's technology could enable earlier clinical interventions, potentially reducing complications and improving outcomes for patients with chronic kidney disease and heart failure.

Immuneering's IMM-1-104 Shows Promise in Phase 2a Trial for Pancreatic Cancer

  • Immuneering's IMM-1-104, combined with modified gemcitabine/nab-paclitaxel, demonstrates an initial 40% overall response rate in first-line pancreatic cancer patients.
  • The Phase 2a trial data reveals an 80% disease control rate among the first five patients treated with the combination therapy.
  • IMM-1-104 has been well-tolerated in combination with chemotherapy, with the Data and Safety Monitoring Board approving dose escalation.
  • These early findings support further clinical development of IMM-1-104, potentially improving outcomes for pancreatic cancer patients.

A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors

NCT05585320Active, Not RecruitingPhase 1
Immuneering Corporation
Posted 10/31/2022

BridgeBio Refocuses on Late-Stage Assets, Trims Pipeline to Sharpen Commercial Focus

• BridgeBio is prioritizing late-stage assets like acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) and infigratinib for achondroplasia, deemed crucial for commercial success. • The company discontinued its BBP-631 gene therapy program for congenital adrenal hyperplasia (CAH) after disappointing Phase 1/2 results, seeking partnerships for further development. • BridgeBio spun out its KRAS-focused oncology portfolio and early-stage assets for tuberous sclerosis complex into new companies to enhance efficiency. • Acoramidis, awaiting FDA decision, faces competition from Pfizer's tafamidis in the ATTR-CM market, with efficacy and dosing frequency being key factors.

HeartSciences Advances AI-ECG Technology for Early Heart Disease Detection

  • HeartSciences is developing cloud and device-based AI-ECG solutions for versatile heart disease detection across healthcare settings.
  • The MyoVista Insights Platform, featuring an LVEF algorithm licensed from Mount Sinai, targets FDA submission in the second half of 2025.
  • FDA 510(k) submission for the MyoVista® wavECG™ device remains on track for the first calendar quarter of 2025.
  • Recent patents granted for detection of ventricular dysfunction using deep learning and MyoVista Wavelet Technology expand HeartSciences' IP.

Inhaled Colistimethate Sodium Shows Efficacy in Non-Cystic Fibrosis Bronchiectasis

  • Phase 3 PROMIS trials demonstrate that inhaled colistimethate sodium (CMS I-neb) significantly reduces pulmonary exacerbations in NCFB patients colonized with P. aeruginosa.
  • The PROMIS-I trial achieved a 39% reduction in annual pulmonary exacerbation rate compared to placebo (p=0.0010), with a 59% reduction in severe exacerbations.
  • CMS I-neb treatment led to clinically important improvements in quality of life and a reduction in P. aeruginosa density among NCFB patients.
  • The treatment was generally well-tolerated, with bronchospasm occurring in fewer than 5% of patients, offering a potential new option for this underserved population.

Lipophilic Statins Linked to Reduced Hepatocellular Carcinoma Risk

  • A recent study utilizing data from the All of Us Research Program found that lipophilic statins, like atorvastatin and simvastatin, are associated with lower odds of hepatocellular carcinoma (HCC).
  • Hydrophilic statins, such as pravastatin and rosuvastatin, along with aspirin and metformin, did not show a similar reduction in HCC risk.
  • The findings suggest that selecting lipophilic statins for patients with statin indications and HCC risk factors may offer a chemopreventive benefit.
  • A multi-center clinical trial (NCT05028829) is underway to further evaluate atorvastatin's potential in reducing HCC risk in high-risk patients.

Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

NCT05028829RecruitingPhase 2
Raymond Chung
Posted 5/10/2023

Cancer Screening Trials: Mortality vs. Late-Stage Diagnosis as Endpoints

  • A recent study highlights the importance of considering cancer-specific mortality as the primary endpoint in cancer screening trials to accurately assess the effectiveness of screening programs.
  • The relationship between late-stage cancer diagnosis and cancer-specific mortality can be influenced by advancements in cancer staging and treatment, impacting the interpretation of trial results.
  • Improvements in cancer treatment across all stages, as indicated by Surveillance, Epidemiology, and End Results data, can affect the ability of screening tests to demonstrate a mortality benefit.
  • Researchers emphasize the need for ongoing evaluation of screening programs in light of evolving treatment landscapes to ensure continued effectiveness in reducing cancer mortality.

Spark Biomedical Receives NIDA Funding to Develop AI for Opioid Withdrawal Detection

  • Spark Biomedical has been awarded a $318,875 SBIR grant from the National Institute on Drug Abuse (NIDA) to develop an AI algorithm for detecting opioid withdrawal symptoms and cravings.
  • The AI algorithm will analyze data from wearable devices that measure digital and physical biomarkers, along with clinical assessments, to proactively identify withdrawal symptoms.
  • The second phase of the project will apply the AI algorithm to trigger closed-loop neurostimulation using Spark Biomedical’s Sparrow Ascent device for timely intervention.
  • The collaboration with Battelle Memorial Institute and Hazelden Betty Ford Foundation aims to improve treatment effectiveness, patient compliance, and reduce relapse rates in opioid use disorder (OUD) recovery.

Digital Twin Technology Mimics Standard of Care in Graft-vs-Host Disease Trial

  • A digital twin (DT) arm, derived from a real-world clinical trial database, effectively mirrored the outcomes of standard-of-care (SOC) treatment for graft-vs-host disease (GVHD).
  • The DT arm, constructed using the Phesi Trial Accelerator platform, showed a 52.7% overall response rate at 6 months, consistent with existing literature on prednisone treatment.
  • Digital twins offer incremental advantages in trial planning, potentially reducing control arm sample sizes and identifying design issues before trial commencement.
  • While digital twins hold promise, challenges remain regarding data privacy, security, and the need for high-quality, unbiased data to ensure accurate model representation.

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.

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