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Clinical Trial News

Merit Medical Enrolls First Patient in WRAPSODY Registry for Hemodialysis Vascular Access

FDA ApprovalReal World Evidence
  • Merit Medical Systems has enrolled the first patient in its WRAP North America registry, a prospective multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY Cell-Impermeable Endoprosthesis for hemodialysis patients.
  • The registry will enroll up to 250 US and Canadian hemodialysis patients experiencing vascular access obstructions such as stenosis or occlusion, with clinical outcomes evaluated over three years.
  • The WRAPSODY CIE received FDA premarket approval in December 2024 and Health Canada approval in April 2025, following superior performance demonstrated in the WAVE pivotal trial.
  • If completed as designed, this registry would represent the largest cohort of patients treated with an implantable device to restore vascular access for hemodialysis.

WRAP North America

NCT06807099Recruiting
Merit Medical Systems, Inc.
Posted 7/31/2025

Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

NCT05062291Recruiting
Merit Medical Systems, Inc.
Posted 6/23/2022

Health Canada Approves Iovance's AMTAGVI as First T-Cell Therapy for Solid Tumors in Canada

Drug Approval
  • Health Canada granted conditional marketing authorization for AMTAGVI, marking the first T-cell therapy approved for solid tumors in Canada, specifically for advanced melanoma treatment.
  • The approval is based on safety and efficacy data from the mid-stage C-144-01 trial, with conditional status pending confirmatory trials to demonstrate clinical benefit.
  • AMTAGVI is indicated for adult patients with unresectable or metastatic melanoma who have progressed after at least one prior systemic therapy and lack satisfactory treatment alternatives.
  • Iovance plans to authorize its first Canadian treatment center within months and continues pursuing approvals in additional international markets including the U.K., Australia, and Switzerland.

Belhaven Biopharma Secures Oversubscribed Series A Funding to Advance First Dry Powder Nasal Epinephrine Therapy

  • Belhaven Biopharma completed an oversubscribed Series A financing round in just six weeks, exceeding its initial $10 million target with strong investor interest.
  • The funding will enable completion of clinical development and commercial manufacturing of Nasdepi®, positioning the company for FDA New Drug Application submission.
  • Nasdepi® represents the first dry powder, needle-free, and heat-stable epinephrine therapy designed for emergency anaphylaxis treatment to reach the market.
  • The innovative intranasal delivery system addresses key limitations of current autoinjector-based epinephrine delivery, including needle phobia and temperature sensitivity.

Greenwich LifeSciences Builds Internal Clinical Team to Reduce Costs and Enhance FLAMINGO-01 Breast Cancer Trial Operations

  • Greenwich LifeSciences is transitioning from external Clinical Research Organizations to an internal clinical trial management team for its Phase III FLAMINGO-01 study to reduce costs and improve efficiency.
  • The strategic shift aims to lower the company's baseline burn rate while enhancing data quality and site monitoring capabilities for the breast cancer immunotherapy trial.
  • The internal team expansion positions Greenwich to potentially conduct multiple simultaneous trials and manage additional pipeline indications or in-licensed drug candidates more cost-effectively.
  • FLAMINGO-01 is evaluating GLSI-100 immunotherapy in HER2-positive breast cancer patients, with plans to enroll approximately 750 patients across up to 150 global sites.

Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

NCT05232916RecruitingPhase 3
Greenwich LifeSciences, Inc.
Posted 8/11/2022

FDA Issues New Draft Guidance for Optimizing Radiopharmaceutical Dosing in Cancer Clinical Trials

Oncology
  • The FDA released draft guidance on August 18, 2025, to help drug sponsors optimize dosing for radiopharmaceutical therapies (RPTs) in oncology clinical development programs.
  • The guidance allows for studying RPT dosages that exceed traditional external beam radiation therapy organ tolerance limits when adequately justified and discussed with FDA.
  • Radiopharmaceuticals represent an evolving cancer treatment modality that combines characteristics of both radiation therapy and systemic drug therapy, requiring specialized dosing considerations.
  • The new guidance provides safeguards including appropriate participant selection, trial design, safety monitoring, and radiation dosimetry evaluation for dosage optimization studies.

Australian Researchers Launch World's First Long COVID Diagnostic Test Trial

  • Australian researchers at the University of Adelaide are recruiting participants for a clinical trial to develop the world's first diagnostic test for long COVID, addressing a critical gap in current medical practice.
  • The trial builds on previous studies showing that COVID-19 can disrupt the immune system long after initial infection, with those experiencing the most severe immune dysfunction later developing long COVID symptoms.
  • Around 5 percent of patients experience persistent symptoms like fatigue, brain fog, and chest pain for over three months after infection, sometimes lasting a year regardless of age or initial infection severity.
  • The study will collect blood samples and symptom questionnaires from long COVID volunteers, with follow-up testing to track biomarkers as symptoms potentially improve.

BeginNGS Newborn Genome Screening Program Expands to Qatar in First International Collaboration

Precision Medicine
  • Rady Children's Institute for Genomic Medicine announced a collaboration with Sidra Medicine in Qatar to implement the BeginNGS genome-based newborn screening program internationally.
  • The partnership aims to screen newborns for over 1,000 treatable genetic disorders, building on Qatar's existing NOOR project for large-scale newborn genome screening.
  • BeginNGS technology reduces false positives by 97 percent and benefits one in 13 infants, currently screening for 511 severe childhood genetic diseases across multiple US hospitals.
  • The collaboration supports the program's goal of implementing screening for 1,000 diseases in at least 10 countries by 2030.

FDA Issues Complete Response Letter for Darzalex Faspro in Newly Diagnosed Multiple Myeloma

Monoclonal AntibodyDrug Approval
  • The FDA issued a complete response letter for Johnson & Johnson's supplemental biologics license application for Darzalex Faspro in combination with VRd for newly diagnosed, transplant-ineligible multiple myeloma patients.
  • The CRL cited observations from facility inspections and was not related to safety and efficacy data, with no additional clinical studies requested by the FDA.
  • The phase 3 CEPHEUS trial demonstrated that D-VRd achieved significantly higher minimal residual disease negativity rates (60.9% vs 39.4%) compared to standard VRd treatment.
  • Darzalex Faspro remains available for all nine currently approved multiple myeloma indications in the United States with no impact on supply or availability.

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

University of Oklahoma Researchers Unlock Amylin Receptor Mechanisms for Next-Generation Obesity Drugs

  • University of Oklahoma researchers published breakthrough findings in Science Signaling revealing new understanding of how amylin receptors function, providing crucial insights for obesity drug development.
  • The study developed novel biochemical and pharmacological methods to analyze how drugs interact with each of the three distinct amylin receptors that control appetite and blood sugar.
  • Researchers discovered that amylin receptors share core components but have unique accessory subunits, and that drugs can either pull these subunits together or push them apart.
  • The findings provide pharmaceutical companies with previously unavailable tools to understand exactly how their amylin-based obesity drugs affect each receptor type.

COUR Pharma Initiates First-in-Class Type 1 Diabetes Trial with CNP-103 Nanoparticle Therapy

  • COUR Pharma has dosed the first patient in a Phase 1b/2a clinical trial evaluating CNP-103, a tolerogenic nanoparticle therapy designed to address underlying autoimmunity in type 1 diabetes.
  • CNP-103 contains four recombinant proteins covering over 95% of known antigens driving type 1 diabetes, aiming to prevent further islet cell destruction and maintain insulin production.
  • The trial targets stage 3 newly diagnosed type 1 diabetes patients, a population with no FDA-approved disease-modifying therapies to combat autoimmune β-cell destruction.
  • The study will assess safety and evaluate CNP-103's ability to preserve islet cell function through maintenance of C-peptide levels in adults aged 18-35 and pediatric patients aged 12-17.

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

NCT06783309RecruitingPhase 1
COUR Pharmaceutical Development Company, Inc.
Posted 5/12/2025

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