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HER2DX® Genomic Test Demonstrates Predictive Value in Advanced HER2+ Breast Cancer

  • REVEAL GENOMICS' HER2DX® test shows a significant association between ERBB2 mRNA levels and survival outcomes in HER2+ breast cancer patients treated with standard therapies.
  • The study, conducted on samples from the CLEOPATRA phase III trial, highlights HER2DX®'s potential in guiding treatment decisions for HER2-positive breast cancer.
  • HER2DX® ERBB2 mRNA score can predict progression-free survival (PFS) and overall survival (OS), potentially aiding in selecting patients for specific anti-HER2 therapies.
  • The findings support the use of HER2DX® to identify patients who may require alternative therapeutic strategies based on their ERBB2 expression levels.

Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy

NCT02411344CompletedPhase 2
Istituto Oncologico Veneto IRCCS
Posted 2/1/2014

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

NCT00567190CompletedPhase 3
Genentech, Inc.
Posted 2/12/2008

Belite Bio Doses First Patient in Phase 2/3 DRAGON II Trial of Tinlarebant for Stargardt Disease

  • Belite Bio has dosed the first patient in the Phase 2/3 DRAGON II trial, evaluating Tinlarebant for Stargardt disease (STGD1) treatment.
  • The DRAGON II trial will assess Tinlarebant's efficacy, safety, and tolerability in approximately 60 adolescent STGD1 subjects across multiple sites.
  • Tinlarebant, an oral therapy, aims to reduce vitamin A-based toxins that contribute to retinal disease in STGD1 and advanced Dry AMD.
  • The trial includes sites in the U.S., U.K., and Japan, with data from Japanese subjects intended to support future NDA applications in Japan.

Academic-Community Collaboration Improves Multiple Myeloma Treatment Outcomes, Experts Report

  • Seamless collaboration between academic and community cancer centers leads to better patient outcomes in multiple myeloma treatment through integrated care delivery and expertise sharing.
  • New bispecific antibodies targeting BCMA and GPRC5D offer promising treatment options for relapsed/refractory multiple myeloma patients, with specific considerations for sequencing with CAR T-cell therapy.
  • Structured referral processes and clear communication channels between community practices and academic centers are crucial for optimal patient care coordination and management of novel therapy-related toxicities.

MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

NCT04649359Active, Not RecruitingPhase 2
Pfizer
Posted 2/2/2021

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

NCT05050097Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/22/2021

Libtayo Demonstrates Durable Survival Benefit in Advanced NSCLC After Five Years

  • Regeneron's Libtayo showed a median overall survival of 26 months compared to 13 months with chemotherapy in PD-L1 high advanced NSCLC patients.
  • The EMPOWER-Lung 1 trial's five-year follow-up highlighted Libtayo's continued clinical benefits and manageable safety profile in advanced NSCLC.
  • Libtayo monotherapy demonstrated a 46.5% objective response rate, significantly higher than the 21% observed with chemotherapy in the study.
  • These results underscore Libtayo's potential as a first-line treatment option for NSCLC patients with high PD-L1 expression and no EGFR, ALK, or ROS1 aberrations.

QurAlis Completes First Cohort Dosing in Phase 1 MAD Trial of QRL-101 for ALS

  • QurAlis has completed dosing the first participant cohort in a Phase 1 multiple-ascending dose (MAD) clinical trial evaluating QRL-101 for ALS.
  • QRL-101 is a first-in-class selective Kv7.2/7.3 ion channel opener designed to reduce hyperexcitability-induced neurodegeneration, present in about 50% of ALS patients.
  • A previous Phase 1 single-ascending dose (SAD) trial with 88 participants showed QRL-101 was well-tolerated, with no significant safety concerns reported.
  • Topline data from the MAD trial is expected in the first half of 2025, which will support larger global studies in people living with ALS.

A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

NCT05667779CompletedPhase 1
QurAlis Corporation
Posted 12/22/2022

A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants

NCT06532396CompletedPhase 1
QurAlis Corporation
Posted 7/1/2024

EMA Rejects Lecanemab: Experts Question Risk-Benefit Assessment and Conflict-of-Interest Policies

  • The European Medicines Agency (EMA) declined to approve lecanemab for early-stage Alzheimer's, creating divergence from regulatory bodies in the US, Japan, and other countries.
  • Concerns arise that the EMA's decision overestimates lecanemab's risks, such as brain swelling or bleeding, while underestimating its potential to extend cognitive function.
  • The EMA's stringent conflict-of-interest policy, excluding experts with industry ties, may limit access to crucial insights and slow down drug approvals.
  • An appeal by Eisai offers a second chance for EMA to approve lecanemab, impacting access for early-stage Alzheimer's patients in Europe.

Cardiol Therapeutics' CardiolRx™ Shows Promise in Myocarditis and Pericarditis Trials

  • Cardiol Therapeutics completes enrollment in Phase II ARCHER trial for acute myocarditis, evaluating CardiolRx™ impact on myocardial recovery.
  • MAvERIC-Pilot study data, presented at AHA Scientific Sessions 2024, highlights CardiolRx™'s effectiveness in reducing recurrent pericarditis pain and inflammation.
  • Cardiol plans MAVERIC-2 trial to assess CardiolRx™ post-IL-1 blocker therapy, alongside a Phase III program for recurrent pericarditis.
  • CardiolRx™ targets the inflammasome pathway, offering a potential non-immunosuppressive treatment for inflammatory heart diseases.

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

NCT05180240CompletedPhase 2
Cardiol Therapeutics Inc.
Posted 6/22/2022

Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

NCT05494788Active, Not RecruitingPhase 2
Cardiol Therapeutics Inc.
Posted 11/30/2022

Delta-Fly Pharma Initiates Phase I/II Trial of DFP-10917 with Venetoclax for Relapsed/Refractory AML

  • Delta-Fly Pharma's Phase I/II trial of DFP-10917 combined with Venetoclax in relapsed/refractory AML patients has enrolled its first patient.
  • The trial, approved by the FDA, will evaluate the combination therapy's complete remission rate and progression-free survival in up to 39 patients.
  • This study follows interest from pharmaceutical companies, including mega-pharmas, due to the large potential market for AML treatments.
  • Delta-Fly Pharma aims to develop a more effective and safer combination therapy compared to the current standard of Venetoclax with Azacitidine.

Zydus Lifesciences' Usnoflast Shows Promise in Phase IIa ALS Trial

  • Zydus Lifesciences has completed a Phase IIa clinical trial of Usnoflast (ZYIL1) in patients with Amyotrophic Lateral Sclerosis (ALS).
  • The trial demonstrated Usnoflast's safety and ability to reach target concentrations in both blood and cerebrospinal fluid.
  • Usnoflast showed a favorable trend in reducing neurofilament light chain levels, a key marker of nerve damage, in ALS patients.
  • Improvements were also observed in ALS Functional Rating Scale scores and Slow Vital Capacity, suggesting potential for slowing disease progression.

Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers

NCT04731324CompletedPhase 1
Zydus Lifesciences Limited
Posted 12/28/2020

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS)

NCT05186051CompletedPhase 2
Zydus Lifesciences Limited
Posted 6/1/2022

Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis

NCT05981040CompletedPhase 2
Zydus Lifesciences Limited
Posted 11/9/2023

A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

NCT06398808CompletedPhase 2
Zydus Lifesciences Limited
Posted 4/8/2024

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers

NCT04972188CompletedPhase 1
Zydus Lifesciences Limited
Posted 7/12/2021

Silo Pharma Completes FDA Pre-IND Meeting for Intranasal PTSD Treatment SPC-15

  • Silo Pharma completed a pre-IND meeting with the FDA for SPC-15, an intranasal prophylactic treatment for PTSD and stress-induced anxiety disorders.
  • The meeting focused on aligning with the FDA on the 505(b)(2) regulatory pathway for SPC-15 approval, potentially shortening clinical timelines and reducing costs.
  • SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist being developed as an intranasal medication for PTSD, anxiety, and other stress-induced affective disorders.
  • Silo Pharma is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study in advance of an IND submission for SPC-15.

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