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Clinical Trial News

Naveris Showcases NavDx Test Advances for HPV-Associated Oropharyngeal Cancer Surveillance at ASTRO 2024

  • Naveris will present new data at the ASTRO Annual Meeting demonstrating the NavDx test's role in managing HPV-driven oropharyngeal cancers.
  • A study analyzing over 1,000 blood samples showed NavDx can identify patients at risk of treatment failure earlier than imaging.
  • Research indicates NavDx can predict outcomes based on HPV DNA clearance during treatment, potentially guiding radiation therapy intensity.
  • Data suggests NavDx outperforms imaging in post-radiotherapy surveillance for oropharyngeal cancer, exhibiting fewer false positives.

Enliven Therapeutics' ELVN-001 Shows Promising Phase 1 Data in Chronic Myeloid Leukemia

  • Enliven Therapeutics announced updated Phase 1 data for ELVN-001, presented at the ESH-iCMLf conference, showing clinical benefit in heavily pretreated CML patients.
  • The trial reported a cumulative major molecular response (MMR) rate of 44.4% by 24 weeks in response-evaluable CML patients treated with ELVN-001.
  • ELVN-001 continues to exhibit a favorable safety profile, with no dose reductions reported and a median treatment duration of 20 weeks across 39 patients.
  • These results suggest ELVN-001's potential to address limitations of current active-site TKIs, particularly for patients who have failed allosteric inhibitors.

A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia

2023-503335-18-00RecruitingPhase 1
Enliven Therapeutics Inc.
Posted 5/22/2022

Anbogen and BeiGene Collaborate to Evaluate Combination Therapy in Colorectal Cancer

  • Anbogen and BeiGene will collaborate in a Phase II trial to evaluate Anbogen's ABT-301 combined with BeiGene's tislelizumab in metastatic colorectal cancer (mCRC) patients.
  • The trial targets patients with mismatch repair–proficient (pMMR) or microsatellite stable (MSS) mCRC, who do not typically respond to immune checkpoint inhibitors.
  • ABT-301, a novel HDAC inhibitor, has shown potential in preclinical studies to enhance the effectiveness of anti-PD-1 therapies by modulating the immune response.
  • The Phase II study will assess the safety, tolerability, and preliminary efficacy of ABT-301 and tislelizumab, with or without Bevacizumab, in advanced MSS CRC patients.

DEA Proposes Increased Production of Psychedelics to Boost Clinical Research

  • The DEA has proposed increasing the production quotas for psilocybin and psilocin by 50% to facilitate research into psychedelic therapies.
  • Ibogaine production is also slated to increase, reflecting a broader effort to explore psychedelics for mental health treatments.
  • These increases signal the DEA's support for psychedelic research, aiming to accelerate FDA approval of new drug products.
  • The move aligns with growing interest in psychedelics for treating conditions like depression, PTSD, and substance use disorder.

Medtronic's PulseSelect Demonstrates Durable Lesion Formation in Atrial Fibrillation Treatment

  • Medtronic's PulseSelect pulsed field ablation (PFA) system shows 98% durable pulmonary vein isolation in AFib patients, according to a new study.
  • The study, presented at APHRS, highlights the system's efficacy with 96% of patients achieving isolation in all veins, approximately two months post-ablation.
  • PulseSelect continues global expansion with approvals in China and Australia, and launch in Japan following reimbursement approval, increasing patient access.
  • The procedure averages 36 minutes, conducted without fluoroscopy, showcasing efficiency and reduced radiation exposure.

FDA Approves GE HealthCare's Flyrcado for Enhanced Coronary Artery Disease Diagnosis

  • Flyrcado (flurpiridaz F 18) injection, a novel PET myocardial perfusion imaging agent, has been approved by the FDA for diagnosing coronary artery disease.
  • Clinical trials demonstrated Flyrcado's superior diagnostic accuracy compared to traditional SPECT MPI, offering improved detection of myocardial ischemia and infarction.
  • The longer half-life of Flyrcado allows for off-site manufacturing and exercise stress testing, potentially expanding access to cardiac PET imaging.
  • Expected to launch in the U.S. in early 2025, Flyrcado represents a significant advancement in nuclear cardiology, promising enhanced diagnostic confidence.

A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

NCT01347710CompletedPhase 3
Lantheus Medical Imaging
Posted 6/1/2011

An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

NCT03354273CompletedPhase 3
GE Healthcare
Posted 6/5/2018

Enanta Biosciences' EDP-938 Demonstrates Efficacy in Phase II RSV Challenge Study

  • Enanta Biosciences' EDP-938 shows promise as a potential respiratory syncytial virus (RSV) therapy based on Phase II challenge study data.
  • The study demonstrated a statistically significant reduction in viral load and clinical symptoms in adults infected with RSV.
  • EDP-938, an N-protein inhibitor, could offer a new treatment option amid the current landscape of RSV therapies and vaccines.
  • These findings support further clinical development of EDP-938 for RSV infection, addressing a significant unmet medical need.

Hypofractionated Radiotherapy Shows Promise in Post-Prostatectomy and Localized Prostate Cancer Treatment

  • A phase II trial (HYPORT-ES) demonstrates that hypofractionated postoperative radiotherapy is safe and effective for prostate cancer, showing a 93% biochemical control rate at three years.
  • Long-term data from a phase III trial indicates that dose-escalated hypofractionated radiation improves 10-year failure rates in localized prostate cancer, particularly in patients not receiving ADT.
  • Hypofractionation offers convenience and comparable or lower toxicity, potentially becoming a standard of care with advanced radiotherapy techniques and individual patient consideration.
  • Research suggests moderate hypofractionation is a safe option, with similar or lower toxicity levels and comparable oncologic outcomes, especially with modern radiation techniques.

Dermatology News Roundup: Bimzelx Expansion, Zoryve sNDA, and HS Insights

  • Bimzelx gains FDA approval for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, marking it as the first IL-17A/F inhibitor for four immune-mediated diseases.
  • Arcutis' Zoryve foam sNDA accepted by the FDA for scalp and body psoriasis, supported by phase 2b and 3 data showing symptom improvement and safety, with a target action date set for May 2025.
  • Semaglutide shows potential in reducing flare-ups and improving quality of life for hidradenitis suppurativa patients, suggesting weight loss medications could complement existing treatments.

GLP-1 Receptor Agonists Show Promise in Treating a Range of Conditions Beyond Diabetes and Obesity

  • GLP-1 receptor agonists, initially developed for type 2 diabetes and weight management, are under investigation for various other conditions, showing potential therapeutic versatility.
  • Research suggests GLP-1s may impact conditions like anxiety, depression, Alzheimer's, Parkinson's, kidney disease, and addiction due to their effects on insulin release, appetite suppression, and inflammation.
  • Ongoing clinical trials are exploring the efficacy of GLP-1 drugs in treating sleep apnea and kidney disease, with pharmaceutical companies seeking FDA approval for expanded indications.
  • The broad action of GLP-1 in the body, affecting the pancreas, hindbrain, and inflammatory responses, underlies its potential to address a wide array of health issues.

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