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Clinical Trial News

IN8bio Pauses INB-400 Glioblastoma Trial to Focus on AML Program

  • IN8bio has suspended enrollment in the phase 2 trial of INB-400, a gamma-delta T-cell therapy, for newly diagnosed glioblastoma multiforme in combination with temozolomide.
  • The company will explore partnership opportunities for its solid tumor drug development program while focusing on its INB-100 program for acute myeloid leukemia (AML).
  • IN8bio's decision is part of a strategic plan to optimize resource allocation and prioritize programs with the potential for near-term value creation.
  • Patients already enrolled in the INB-400 and INB-200 trials will continue to be monitored for long-term remissions and overall survival.

Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients with Newly Diagnosed Glioblastoma

NCT04165941Active, Not RecruitingPhase 1
University of Alabama at Birmingham
Posted 2/11/2020

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma

NCT05664243Active, Not RecruitingPhase 1
In8bio Inc.
Posted 9/8/2023

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

NCT03533816RecruitingPhase 1
University of Kansas Medical Center
Posted 1/31/2020

Etoricoxib/Tramadol Combination Shows Promise for Acute Low Back Pain Relief

  • A phase III clinical trial evaluated a fixed-dose combination of etoricoxib and tramadol for acute low back pain, compared to paracetamol and tramadol.
  • The etoricoxib/tramadol combination demonstrated a greater reduction in pain intensity and disability compared to the paracetamol/tramadol combination.
  • The study suggests that etoricoxib/tramadol offers a faster therapeutic response and opioid-sparing effect, potentially improving treatment adherence and reducing adverse events.
  • The findings support the use of multimodal analgesia with etoricoxib and tramadol as a beneficial therapeutic option for managing acute low back pain.

Two-Stage Screening Model Improves OSA Detection in Primary Care

  • A two-stage screening model using the STOP-BANG questionnaire (SBQ) followed by automated home sleep apnea testing (HSAT) enhances obstructive sleep apnea (OSA) detection in primary care.
  • Automated HSAT scoring shows excellent correlation with manual scoring, with a slight overestimation of the respiratory event index (REI) but high interrater reliability.
  • The two-stage model demonstrates good diagnostic properties, with a sensitivity of 64% and specificity of 97.4% for detecting any OSA (REI ≥ 5).
  • Implementing this model could reduce referrals for sleep studies by 15.3% compared to using the SBQ questionnaire alone, streamlining OSA diagnosis.

Matregenix Secures $4.2M in Contracts to Advance Nanofiber Soft Tissue Repair

  • Matregenix has been awarded three Phase II Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) contracts from the Department of the Air Force (DAF).
  • The contracts, totaling over $4.2 million, will support the development of nanofiber technologies for soft tissue repair applications within the DAF.
  • These awards bring Matregenix's total funding from AFWERX to over $4.5 million, enabling the company to advance its biomedical technologies.
  • The nanofiber solutions aim to address unmet medical needs for both military personnel and civilians, strengthening national defense capabilities.

Kintara Therapeutics Announces Corporate Updates and REM-001 Clinical Study Progress

  • Kintara Therapeutics is set to hold a special meeting on September 20, 2024, to approve its merger with TuHURA Biosciences, aiming to enhance its oncology pipeline.
  • The REM-001 study has enrolled four patients with cutaneous metastatic breast cancer, showing no treatment-related safety issues and progressing towards Phase 3 dose assessment.
  • Kintara emphasizes that the merger with TuHURA is crucial for continued operation and funding of the REM-001 study, urging stockholders to vote in favor.

Global Research Community Applies COVID-19 Lessons to Combat African Mpox Emergency

  • The World Health Organization has declared mpox outbreak in Africa a Public Health Emergency of International Concern, prompting urgent calls for enhanced treatment accessibility and research efforts.
  • Researchers are leveraging COVID-19 pandemic experiences, including adaptive trial designs, real-time data collection, and streamlined regulatory processes, to accelerate mpox vaccine development.
  • While infrastructure and expertise from COVID-19 research could benefit mpox trials, challenges remain in financing, logistics, and healthcare access in affected African regions.

Suzetrigine: Hope or Hype for New Non-Opioid Pain Relief?

  • The FDA is considering suzetrigine, a non-opioid analgesic from Vertex Pharmaceuticals, for priority review, potentially marking a new class of pain medication in over two decades.
  • Suzetrigine received 'Fast Track' and 'Breakthrough Therapy' designations for moderate-to-severe acute pain, but is currently studied only for diabetic peripheral neuropathy.
  • While hailed as a potential solution to the opioid crisis, questions remain about suzetrigine's efficacy compared to existing treatments, leading to skepticism about its true impact.
  • The FDA's eagerness to approve non-opioid alternatives may be driving the fast-track designation, raising concerns whether the drug's benefits justify the accelerated approval process.

Hydroxychloroquine Shows Moderate COVID-19 Prevention in Large Clinical Trial

  • A large, double-blind, placebo-controlled trial (COPCOV) found a 15% reduction in symptomatic COVID-19 with hydroxychloroquine compared to placebo.
  • The study also demonstrated a significant reduction in all-cause respiratory illness and fewer workdays lost due to illness among those taking hydroxychloroquine.
  • Hydroxychloroquine was well-tolerated and safe in the study, which included over 4,600 participants across 11 countries from 2020 to 2022.
  • Researchers emphasize that current immunity from vaccines and natural infections has reduced COVID-19 severity, making hydroxychloroquine unnecessary for prevention today.

Tacrolimus Eye Drops with Cyclodextrins Show Improved Safety and Compliance in Ocular Inflammatory Pathologies

  • A new formulation of 0.015% tacrolimus eye drops with hydroxypropyl-beta-cyclodextrin (HPβCD) was compared to a 0.03% tacrolimus formulation with ethanol (TE).
  • The HPβCD formulation (TCD) demonstrated comparable effectiveness to TE, with significant improvements in patient-reported burning sensations and ocular pain.
  • Patient adherence increased significantly with TCD, likely due to the removal of ethanol, an irritant excipient, leading to better tolerability and reduced ocular surface toxicity.
  • The study suggests that TCD is a safer and more compliant alternative for managing ocular inflammatory pathologies, with potential for wider adoption in hospital pharmacy departments.

Survodutide Shows Promise in Obesity and MASH with Significant Weight and Blood Pressure Reduction

  • Survodutide, a novel dual GCGR/GLP-1R agonist, demonstrates significant weight reduction in overweight or obese patients, with nearly 40% achieving over 20% body weight reduction after 46 weeks.
  • Phase II trial results indicate survodutide substantially reduces blood pressure in patients with metabolic dysfunction-associated steatohepatitis (MASH), showing promise in this area.
  • The dual mechanism of action of survodutide offers benefits in lowering body weight and promoting blood pressure reduction without causing muscle loss, according to study findings.
  • Adverse events leading to discontinuation were mainly due to rapid dose escalation, suggesting a more gradual approach could mitigate this issue and improve tolerability.

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

NCT04771273CompletedPhase 2
Boehringer Ingelheim
Posted 4/27/2021

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

NCT04667377CompletedPhase 2
Boehringer Ingelheim
Posted 3/8/2021

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