MedPath

Clinical Trial News

Neuralink Receives Approval for Brain Chip Clinical Trial in Canada

  • Neuralink has been approved by Health Canada to begin recruiting for its first clinical trial in the country, marking a significant step for the BCI startup.
  • The trial will focus on evaluating the safety and initial functionality of Neuralink's implant for individuals with quadriplegia, aiming to restore autonomy.
  • This Canadian trial mirrors Neuralink's ongoing efforts in the U.S., where the company has already implanted the device in two patients.
  • Neuralink's technology allows users to control digital devices through thought alone, potentially improving the lives of those with severe motor impairments.

MD Anderson Clinical Trials and Targeted Therapy Extend Lung Cancer Survivor's Life Through Multiple Diagnoses

  • Diane White, diagnosed with stage III non-small cell lung cancer, benefited from MD Anderson's clinical trials involving immunotherapy and radiation therapy.
  • The identification of an EGFR mutation led to treatment with osimertinib, a targeted therapy, which effectively halted tumor growth, showcasing personalized medicine.
  • Despite subsequent diagnoses of breast cancer and brain metastases, ongoing monitoring and treatment adjustments have maintained Diane's lung cancer as inactive.
  • Diane emphasizes the importance of a positive attitude and MD Anderson's comprehensive care in managing her cancer journey and maintaining a high quality of life.

FDA Grants Accelerated Approval to Zanidatamab for HER2-Positive Biliary Tract Cancer

• The FDA has granted accelerated approval to zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. • Approval was based on the HERIZON-BTC-01 trial, which demonstrated a 52% objective response rate and a median duration of response of 14.9 months. • Zanidatamab, a bispecific HER2-directed antibody, is administered intravenously every two weeks at a dose of 20 mg/kg until disease progression or unacceptable toxicity. • The FDA also approved the Ventana PATHWAY anti-HER-2/neu antibody as a companion diagnostic to identify patients eligible for zanidatamab treatment.

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

NCT04466891CompletedPhase 2
Jazz Pharmaceuticals
Posted 10/1/2020

Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target for Early Readout

  • Diamyd Medical's DIAGNODE-3 trial, a Phase 3 precision medicine study, has recruited 180 patients, surpassing the target for its planned early readout in March 2026.
  • The early readout is intended to support a potential accelerated Biologics License Application (BLA) to the FDA for Diamyd® in Type 1 Diabetes.
  • DIAGNODE-3 evaluates Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes, focusing on the HLA DR3-DQ2 haplotype.
  • The trial assesses the preservation of endogenous insulin production (C-peptide) and glycemic control (HbA1c) over 24 months in approximately 330 patients.

FDA Approves Study on Marijuana for PTSD Treatment in Veterans

  • The FDA has authorized a clinical trial to assess the safety and efficacy of marijuana for treating PTSD in military veterans, reversing a previous rejection in 2021.
  • This decision marks a rare instance where the FDA permits smoking marijuana in a study focused on its therapeutic benefits rather than its harms.
  • Federal health officials acknowledge the significant need for additional treatment options for mental health conditions like PTSD, signaling a shift towards further research on cannabis.
  • Legalization and associated tax revenue are enabling states to expand studies into marijuana’s efficacy for therapeutic uses, complementing federally prioritized research on its harms.

Polarean Imaging Receives FDA Clearance to Expand MRI Chest Coil Compatibility

  • Polarean Imaging secured FDA 510k clearance for its MRI chest coil to include GE Healthcare's 3 Tesla MRI scanners, enhancing Xenon-129 nuclei visualization.
  • The expanded clearance ensures Polarean's Xenon MRI technology is accessible to more institutions and clinicians across the U.S. for lung disease detection.
  • With this approval, Polarean now supports Xenon MRI scanning from all three major scanner vendors: GE Healthcare, Koninklijke Philips NV, and Siemens Healthineers AG.

FDA Grants Accelerated Approval to Jazz Pharmaceuticals' Ziihera for HER2-Positive Biliary Tract Cancer

• The FDA has granted accelerated approval to Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) for previously treated HER2-positive biliary tract cancer (BTC). • This approval marks Ziihera as the first dual HER2-targeted bispecific antibody and chemotherapy-free option for BTC treatment in the US. • The approval was based on a Phase IIb study demonstrating a 52% objective response rate and a median duration of response of 14.9 months. • Jazz Pharmaceuticals is also evaluating Ziihera in studies for gastroesophageal adenocarcinoma, metastatic breast cancer, and other HER2-positive solid tumors.

Zanidatamab Gains NCCN Recommendation and Companion Diagnostic Approval for HER2+ Biliary Tract Cancer

• Zanidatamab, a bispecific antibody targeting HER2, has been added to the NCCN guidelines as a category 2A treatment option for HER2-positive biliary tract cancer (BTC). • The FDA approved PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test as a companion diagnostic to identify BTC patients eligible for zanidatamab. • HERIZON-BTC-01 trial data demonstrated a 52% objective response rate and a median duration of response of 14.9 months with zanidatamab in pretreated HER2+ BTC. • Ongoing phase 3 HERIZON-BTC-302 trial is evaluating zanidatamab plus standard-of-care therapy vs standard-of-care alone in the first-line treatment of HER2-positive BTC.

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

NCT04466891CompletedPhase 2
Jazz Pharmaceuticals
Posted 10/1/2020

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123CompletedPhase 1
Jazz Pharmaceuticals
Posted 9/30/2016

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

NCT06282575RecruitingPhase 3
Jazz Pharmaceuticals
Posted 7/19/2024

MD Anderson Highlights: Modified NRF2 Activator Reverses Chronic Pain, Canakinumab Shows Promise in MDS Subgroup

  • A modified NRF2 activator, designed to release specifically in response to oxidative stress, effectively reversed chronic pain in lab models while reducing unwanted side effects.
  • In a Phase II trial, canakinumab showed a modest overall response in lower-risk MDS patients, with benefits most evident in those with lower genetic complexity.
  • Research identifies specific microRNAs that shape the tumor immune microenvironment in chronic lymphocytic leukemia (CLL), highlighting their potential as therapeutic targets.
  • A Phase II trial demonstrates that induction chemotherapy before surgery improves outcomes for patients with advanced sinonasal squamous cell carcinoma.

Psychedelic Therapy Faces Regulatory Hurdles Despite Promising Research

  • The FDA's rejection of Lykos Therapeutics' MDMA therapy for PTSD highlights challenges in psychedelic research, emphasizing the need for consistent and predictable clinical trial outcomes.
  • Regulatory focus on drug components over therapy combinations necessitates innovative approaches for integrating psychotherapy with psychedelic treatments, potentially involving collaborations between the FDA and professional organizations.
  • NIDA's funding of ketamine studies signals growing acceptance of psychedelics' therapeutic potential, driving further research into their efficacy for conditions like depression and PTSD.
  • Key research areas include determining the durability of treatment effects and understanding how psychedelics impact diverse populations, requiring meticulous trial designs and robust data collection.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.