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Clinical Trial News

Decipher Genomic Test Predicts Chemotherapy Benefit in Metastatic Prostate Cancer

  • The Decipher Prostate Genomic Classifier test successfully identified metastatic prostate cancer patients who benefit from docetaxel chemotherapy, showing a 36% reduction in death risk for high-scoring patients.
  • Among 832 metastatic prostate cancer patients in the STAMPEDE trial, those with high Decipher scores had significant survival improvement with docetaxel, while lower-scoring patients showed minimal benefit.
  • The 22-gene test becomes the first molecular diagnostic with randomized trial evidence to guide chemotherapy decisions in metastatic prostate cancer, potentially sparing patients from unnecessary treatment side effects.
  • Additional analysis revealed that combining Decipher scores with PTEN status further refined patient selection, with high Decipher/PTEN inactive tumors showing 45% reduction in death hazards with docetaxel.

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

NCT00268476Active, Not RecruitingPhase 2
Medical Research Council
Posted 7/8/2005

Neusoft Medical Systems Receives NMPA Approval for China's First Photon-Counting CT Scanner

  • Neusoft Medical Systems' NeuViz P10 photon-counting CT has received market approval from China's National Medical Products Administration, marking the first photon-counting CT approved in China.
  • The system represents a breakthrough in next-generation imaging technology, using cadmium zinc telluride detectors to directly convert X-ray photons into digital signals for superior image clarity and reduced radiation exposure.
  • The NeuViz P10 is the world's first wide-body photon-counting CT system equipped with an 8-cm detector, enabling clearer visualization of blood vessels, earlier tumor detection, and more accurate neurological assessments.

CUNY Researchers Develop First Broad-Spectrum Antiviral Targeting Viral Envelope Glycans

  • Researchers at the City University of New York have identified synthetic carbohydrate receptors that successfully blocked infection from seven different viruses across five unrelated families, including Ebola, Marburg, and SARS-CoV-2.
  • In critical testing, 90 percent of mice infected with SARS-CoV-2 survived when treated with the lead compound, compared to none in the control group.
  • The compounds work by targeting viral envelope glycans, sugar molecules that are structurally conserved across unrelated viral families and represent a novel mechanism of action.
  • Phase I clinical trials are anticipated to begin in 2028, potentially offering the world's first broad-spectrum antiviral for immediate deployment against future pandemic threats.

MHRA Launches Route B Pilot to Streamline Clinical Trial Modifications Ahead of 2026 Regulatory Overhaul

  • The UK's MHRA is launching a Route B substantial modification pilot from October 1, 2025 to March 31, 2026, offering automatic approval within 14 days for eligible clinical trial changes.
  • The pilot prepares for new clinical trials regulations taking effect April 28, 2026, which will consolidate existing notification schemes into a unified "Notifiable Trials" framework.
  • Route B modifications must meet pre-defined eligibility criteria under section 11B of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 and undergo risk-proportionate review rather than full assessment.
  • The existing voluntary notification scheme for Type A trials will close on September 30, 2025, as part of the transition to the new regulatory framework.

Lilly's Verzenio Demonstrates Significant Overall Survival Benefit in High-Risk Early Breast Cancer

Oncology
  • Eli Lilly's Verzenio plus endocrine therapy demonstrated statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy alone in patients with HR+, HER2-, node-positive, high-risk early breast cancer.
  • The seven-year landmark analysis of the monarchE trial also showed sustained benefit in invasive disease-free survival and distant relapse-free survival, reinforcing the consistency and durability of treatment effects.
  • These results validate Verzenio as the standard-of-care for patients with node-positive, high-risk disease and represent a major milestone for CDK4/6 inhibitor therapy in the adjuvant setting.
  • The monarchE study enrolled 5,637 adults across more than 600 sites in 38 countries, making it the only adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a node-positive, high-risk early breast cancer population.

Evommune Initiates Phase 2b Trial of Oral MRGPRX2 Antagonist EVO756 for Moderate to Severe Atopic Dermatitis

  • Evommune has enrolled the first patient in a Phase 2b trial evaluating EVO756, an oral MRGPRX2 antagonist, in approximately 120 adults with moderate to severe atopic dermatitis over 12 weeks.
  • The trial's primary endpoint measures percentage change in Eczema Area and Severity Index (EASI) from baseline to week 12, with a key secondary endpoint evaluating itch severity using the Pruritus-NRS scale.
  • EVO756 targets MRGPRX2, a receptor that mediates neurogenic inflammation by triggering mast cell degranulation and inflammatory mediator release when activated by ligands common in inflammation.
  • Top-line results from the Phase 2b trial are expected in the second half of 2026, representing the company's second Phase 2b program with EVO756.

Azitra Doses First Patient in Phase 1/2 Trial of Live Biotherapeutic for EGFR Inhibitor-Associated Rash

  • Azitra has dosed the first patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic designed to treat EGFR inhibitor-associated rash affecting approximately 150,000 people annually in the U.S.
  • The multicenter, randomized, double-blind study will evaluate the safety and tolerability of the engineered Staphylococcus epidermidis strain, which was selected for its ability to reduce IL-36γ and S. aureus levels elevated in EGFRi-associated skin rash.
  • EGFR inhibitor-associated papulopustular rash occurs in 50-80% of patients receiving these targeted cancer therapies and can severely impact quality of life, often leading to treatment interruption or discontinuation.
  • The FDA has granted Fast Track designation for ATR04-484, highlighting the critical unmet medical need for managing dermatologic toxicities that accompany EGFRi treatments across multiple cancer types including NSCLC and colorectal cancer.

A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity

NCT06830863RecruitingPhase 1
Azitra Inc.
Posted 6/15/2025

Minovia Therapeutics Secures $350,000 Grant to Develop Blood-Based Mitochondrial Biomarkers

  • Minovia Therapeutics received a $350,000 grant from Countdown for a Cure Foundation to develop novel mitochondrial blood-based biomarkers for patient identification and treatment monitoring.
  • The funding will support clinical operations to collect blood samples from approximately 30 patients with primary mitochondrial diseases and 140 healthy controls at Sheba Medical Center.
  • The company aims to develop a "MitoScore" system to quantify mitochondrial content, quality and function, addressing the current lack of approved therapies and functional diagnostic tests for mitochondrial dysfunction.
  • Minovia is simultaneously advancing its mitochondrial augmentation technology (MAT) platform and preparing for a business combination with Launch One Acquisition Corp projected for late 2025.

CRISPR Gene Therapy Exa-cel Delivers Sustained Quality of Life Improvements in Blood Disorders

Drug ApprovalGene Editing
  • Treatment with exagamglogene autotemcel (exa-cel), a CRISPR-based gene therapy, led to significant and sustained improvements in health-related quality of life for patients with severe sickle cell disease and transfusion-dependent beta thalassemia.
  • Patients with sickle cell disease saw quality of life scores not only improve but exceed population norms, with adult patients experiencing the largest gains in social and emotional functioning.
  • Beta thalassemia patients reported mean gains of 14.0 points in EQ-5D-5L scores by month 48 for adults and 6.1 points by month 24 for adolescents, all exceeding minimal clinically important difference thresholds.
  • The findings represent among the first quantified patient-reported quality-of-life changes following CRISPR-based gene editing treatment, based on data from ongoing clinical trials with median follow-up of 33.6 months for sickle cell disease and 38.4 months for beta thalassemia.

Wugen Secures $115 Million to Advance First-in-Class Off-the-Shelf CAR-T Therapy for T-Cell Malignancies

CAR-TOncology
  • Wugen raised $115 million in financing led by Fidelity Management & Research to advance its pivotal T-RRex trial of WU-CART-007, an off-the-shelf CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
  • WU-CART-007 demonstrated exceptional efficacy in Phase 1/2 trials with a 91% overall response rate and 73% complete remission rate, substantially outperforming current standard-of-care therapies for these aggressive malignancies.
  • The company aims to file a Biologics License Application in 2027, positioning WU-CART-007 as the potential first approved allogeneic CAR-T therapy for T-cell malignancies.
  • The therapy uses CRISPR gene editing technology and donor-derived cells to create an accessible, scalable treatment that eliminates the need for patient-specific cell extraction and manipulation.

A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

NCT04984356CompletedPhase 1
Wugen, Inc.
Posted 1/14/2022

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

NCT06514794RecruitingPhase 2
Wugen, Inc.
Posted 1/31/2025

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