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Clinical Trial News

Novel Therapies and Lifestyle Interventions Show Promise in Hypertension Management

  • Recent trials highlight the potential of salt substitution and restriction in lowering blood pressure, particularly in elderly care facilities, showcasing significant cardiovascular benefits.
  • Emerging drug therapies, including aldosterone synthase inhibitors like baxdrostat and lorundrostat, demonstrate efficacy in treatment-resistant hypertension by targeting aldosterone production.
  • Bariatric surgery has shown sustained reductions in blood pressure over five years in obese patients with hypertension, suggesting a durable impact on cardiovascular health.
  • SGLT2 inhibitors, initially for diabetes, are recognized for their beneficial effects on blood pressure regulation, offering a dual-action approach for patients with both conditions.

Adaptive Trial Aims to Break Impasse in Traumatic Brain Injury Treatment

• A new clinical trial is launched across 18 trauma centers to evaluate existing drugs for treating moderate to mild traumatic brain injury (TBI). • The adaptive platform trial design allows simultaneous testing of multiple drugs and the addition/removal of therapies based on efficacy. • The trial leverages recent biomarker and CT scan research to improve patient selection and monitor treatment progress. • Funded by the Department of Defense, the study addresses the urgent need for effective TBI treatments, which affects millions.

Rintatolimod and Durvalumab Combination Shows Promise in Late-Stage Pancreatic Cancer

  • Preliminary data from the DURIPANC trial indicates that rintatolimod plus durvalumab demonstrates early disease control in late-stage pancreatic cancer.
  • Two of three patients in the first dose cohort maintained stable disease at 6 months, with ongoing treatment and assessment.
  • The combination therapy was generally well-tolerated, with no severe adverse effects observed in the first cohort.
  • Improvements in quality of life were noted, correlating with stable disease, offering hope for patients with limited treatment options.

Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy

NCT05927142RecruitingPhase 1
Joachim Aerts, MD PhD
Posted 1/9/2024

UNLV and Global Alzheimer's Platform Foundation Partner to Advance Alzheimer's Research

  • UNLV and the Global Alzheimer’s Platform Foundation (GAP) are collaborating to accelerate the development of new diagnostic tests and biomarkers for Alzheimer’s and other CNS diseases.
  • The partnership aims to expand access to clinical trials in Southern Nevada, focusing on including participants from diverse communities.
  • The collaboration will leverage UNLV's Pam Quirk Brain Health Biomarker Laboratory and GAP's biomarker datasets to enhance research capabilities.
  • UNLV students will gain opportunities in brain science and clinical research, with plans for an annual conference on biomarker technologies.

VITdALIZE-KIDS Trial Assesses Vitamin D Supplementation Impact on Pediatric ICU Patients' Quality of Life

  • The VITdALIZE-KIDS trial is a phase III, multicenter, randomized, double-blind study evaluating high-dose vitamin D supplementation in critically ill children with vitamin D deficiency.
  • The primary outcome is health-related quality of life (HRQL) measured by the PedsQL™ scale at 28 days post-intervention, with secondary outcomes including hospital length of stay and adverse events.
  • The trial aims to enroll 766 patients across 11 Canadian PICUs, randomizing them to either a high-dose cholecalciferol bolus or a placebo, with a metabolomics sub-study planned for a subset.
  • Interim analyses are scheduled to assess efficacy and safety, with a DSMB providing oversight and the potential for early termination based on futility or safety concerns.

Rapid Normalization of Vitamin D Deficiency in PICU

NCT03742505CompletedPhase 3
Children's Hospital of Eastern Ontario
Posted 6/17/2019

Ryvu Therapeutics Doses First Patient in Phase II REMARK Trial of RVU120 for Lower-Risk MDS

  • Ryvu Therapeutics has dosed the first patient in the Phase II REMARK trial, evaluating RVU120 for anemia in lower-risk myelodysplastic syndromes (LR-MDS).
  • The REMARK study, an investigator-initiated trial through the EMSCO network, will enroll approximately 40 patients across 25 global clinical sites.
  • RVU120, a novel CDK8/19 inhibitor, is being explored as a monotherapy for LR-MDS patients who have exhausted other treatment options.
  • The trial's primary goal is to achieve hematologic improvement, with secondary endpoints including transfusion independence and improved hemoglobin levels.

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML

NCT06191263RecruitingPhase 2
Ryvu Therapeutics SA
Posted 1/5/2024

RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis

NCT06397313RecruitingPhase 2
Ryvu Therapeutics SA
Posted 9/19/2024

A phase II, open-label, multicenter study of orally administered RVU120 for the treatment of anemia in patients with lower-risk myelodysplastic neoplasms (MDS)

2023-509947-29-00Active, Not RecruitingPhase 2
GCP-Service International West GmbH

Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML

NCT06268574Active, Not RecruitingPhase 2
Ryvu Therapeutics SA
Posted 1/23/2024

Mpox Vaccine Shows Safety and Robust Immune Response in Adolescents

  • A NIH-funded clinical trial found the MVA-BN mpox vaccine safe and effective in adolescents aged 12-17, generating antibody responses similar to those in adults.
  • Interim analysis showed adolescents had higher geometric mean titers (GMT) compared to adults after two doses of the MVA-BN vaccine, indicating a strong immune response.
  • The EMA has recommended extending the use of the Imvanex vaccine to adolescents, based on data showing similar immune responses and safety profiles as in adults.
  • These findings support the use of the MVA-BN vaccine in adolescents, especially in areas with ongoing mpox outbreaks, while further studies in younger children are needed.

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine

NCT05512949CompletedPhase 2
National Institute of Allergy and Infectious Diseases (NIAID)
Posted 9/9/2022

SGLT-2 Inhibitors Linked to Reduced Dementia and Parkinson's Risk in Type 2 Diabetes Patients

  • A recent study suggests that SGLT-2 inhibitors, used for type 2 diabetes, are associated with a lower risk of dementia and Parkinson's disease.
  • The research, involving over 220,000 type 2 diabetes patients, found a 35% reduced risk of dementia with SGLT-2 inhibitors compared to DPP-4 inhibitors.
  • SGLT-2 inhibitor use was linked to a 39% lower risk of Alzheimer's and a 52% lower risk of vascular dementia.
  • The study highlights the potential for repurposing existing drugs like SGLT-2 inhibitors to address neurodegenerative diseases.

Pharmacosmos Completes Strategic Acquisition of G1 Therapeutics in Multi-Million Dollar Deal

  • Danish pharmaceutical company Pharmacosmos has finalized its acquisition of US-based G1 Therapeutics, gaining ownership of the cancer drug Cosela in a deal valued at over half a billion kroner.
  • The acquisition represents a significant expansion for Pharmacosmos, traditionally focused on iron deficiency treatments, into the oncology market with an established commercial product.
  • Company executives indicate they will focus on integration over the next six months, with potential for additional acquisitions in the longer term but not immediately.

FDA Rejects Vanda's Tradipitant for Gastroparesis, Citing Insufficient Evidence

  • The FDA issued a Complete Response Letter for Vanda Pharmaceuticals' tradipitant, a neurokinin-1 receptor antagonist, for treating gastroparesis symptoms.
  • The FDA's decision was based on the need for additional studies, which Vanda argues are inconsistent with expert advice and current understanding of gastroparesis.
  • Vanda plans to continue pursuing marketing authorization for tradipitant and will proceed with a separate NDA submission for motion sickness prevention.
  • Gastroparesis, affecting both diabetic and non-diabetic individuals, lacks effective treatments, making this rejection a setback for patients.

Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

NCT02970968CompletedPhase 2
Vanda Pharmaceuticals
Posted 11/1/2016

Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

NCT04474990available
Vanda Pharmaceuticals

Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

NCT04028492CompletedPhase 3
Vanda Pharmaceuticals
Posted 8/20/2019

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