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Clinical Trial News

Tonix Pharmaceuticals Submits NDA for TNX-102 SL for Fibromyalgia Treatment

  • Tonix Pharmaceuticals has submitted an NDA to the FDA for TNX-102 SL, a non-opioid analgesic, seeking approval for fibromyalgia treatment.
  • TNX-102 SL demonstrated statistically significant pain reduction in two Phase 3 trials, offering a potential new option for fibromyalgia patients.
  • If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years, representing a novel tricyclic class of medicine.
  • The FDA has granted Fast Track designation to TNX-102 SL, with a PDUFA date expected in 2025 for a decision on approval.

Risk Prediction Model Identifies Cancer Patients Prone to ER Visits During Clinical Trials

  • A new risk prediction model identifies advanced cancer patients in clinical trials at high risk for unplanned ER visits and hospital stays.
  • The model incorporates factors like performance status, coronary artery disease, hypertension, liver disease, and prostate cancer status.
  • Patients with two or more risk factors had over three times the risk of acute care use, highlighting the need for targeted interventions.
  • The model's validation supports its use in improving care quality and reducing costs by identifying high-risk patients for proactive management.

CAR T-cell Therapy Monitoring: Study Suggests Reduced REMS May Improve Accessibility

  • A recent study suggests that the FDA's Risk Evaluation and Mitigation Strategy (REMS) for CAR T-cell therapy may be overly restrictive, impacting patient accessibility.
  • The study found that the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is low after the first two weeks post-CAR T infusion.
  • Researchers propose a more flexible approach to monitoring, with a mandatory 2-week period near the treatment center, followed by individualized assessments.
  • Revisiting REMS mandates could reduce the physical and financial burden on patients, potentially improving access to CAR T-cell therapy, especially for underserved populations.

Zr-89 Girentuximab PET-CT Shows Promise in Detecting Clear Cell Renal Cell Carcinoma

  • A phase III trial demonstrated that Zr-89 girentuximab PET-CT imaging accurately detects clear cell renal cell carcinoma (RCC) in patients with indeterminate renal masses.
  • The imaging technique showed a mean sensitivity of 85.5% and specificity of 87.0% across three independent readers for clear cell RCC detection.
  • The study reported a favorable safety profile for Zr-89 girentuximab, with most adverse events occurring post-surgery and few related to the imaging agent.
  • Researchers suggest Zr-89 girentuximab PET-CT could be a practice-changing, non-invasive modality for characterizing clear cell RCC.

Fecal Microbiota Transplants Show Promise in Overcoming Immunotherapy Resistance in GI Cancers

  • A South Korean study suggests fecal microbiota transplants (FMTs) may enhance immunotherapy efficacy in gastrointestinal (GI) cancer patients resistant to anti-PD-1 drugs.
  • The study found that 46.2% of patients with metastatic solid tumors refractory to nivolumab benefited from FMTs, showing tumor shrinkage in some cases.
  • Specific bacterial strains, like Prevotella merdae, improved FMT effectiveness, while others, such as Lactobacillus salivarius, had detrimental impacts.
  • Researchers emphasize the need for efficient FMT production methods and further clinical trials to integrate FMT into standard cancer treatment.

NeuroSense Therapeutics Regains Compliance with NASDAQ, Plans Phase 3 Trial for PrimeC

  • NeuroSense Therapeutics has regained compliance with Nasdaq's minimum bid price requirement, ensuring continued listing on the exchange.
  • This milestone follows positive Phase 2b trial results for PrimeC, a treatment for neurodegenerative diseases.
  • The company is now focused on initiating a Phase 3 trial of PrimeC in the United States.
  • NeuroSense is also in discussions with potential partners to further the development and commercialization of PrimeC.

Roche Unveils TAGS Technology: Revolutionary Multi-Pathogen Detection System for Infectious Diseases

  • Roche introduces TAGS (Temperature-Activated Generation of Signal) technology, enabling detection of up to 15 diagnostic targets from a single patient sample, marking a significant advance in infectious disease testing.
  • The first application, cobas Respiratory flex panel, can simultaneously screen for 12 respiratory viruses including influenza, COVID-19, and RSV, compatible with existing Roche diagnostic platforms.
  • The technology enhances conventional PCR testing by incorporating multiple diagnostic criteria, potentially revolutionizing hospital laboratory testing efficiency and improving patient care delivery.

FDA Accepts LEO Pharma's Delgocitinib Cream NDA for Chronic Hand Eczema

  • The FDA has accepted LEO Pharma's New Drug Application (NDA) for delgocitinib cream 2% for treating moderate to severe Chronic Hand Eczema (CHE) in adults.
  • The NDA is supported by Phase 3 DELTA 1 and DELTA 2 clinical trials, which demonstrated the efficacy and safety of delgocitinib cream compared to a cream vehicle.
  • Delgocitinib cream is an investigational topical pan-JAK inhibitor that addresses the unmet need for CHE patients who have inadequate responses to topical corticosteroids.
  • The FDA regulatory review process is expected to conclude in the second half of 2025, potentially offering a new treatment option for this debilitating condition.

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

NCT04871711CompletedPhase 3
LEO Pharma
Posted 5/10/2021

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

NCT04872101CompletedPhase 3
LEO Pharma
Posted 5/25/2021

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

NCT04949841CompletedPhase 3
LEO Pharma
Posted 8/23/2021

Cenna Biosciences Awarded NIH Grant for Alzheimer's Disease Drug Development

  • Cenna Biosciences receives a $2.7M Phase II SBIR grant from the NIH's National Institute on Aging to advance Nubytide™ for Alzheimer's disease.
  • Nubytide™, a novel peptide drug, targets the production of toxic Aβ species, offering a potentially safer alternative to monoclonal antibody therapies.
  • The funding supports IND-enabling studies and Phase 1 clinical trials, with an IND filing anticipated in early 2025.
  • Cenna's approach aims to modify the disease course, potentially preventing or delaying Alzheimer's progression, addressing a critical unmet need.

Rimegepant Shows Consistent Efficacy and Safety in Pooled Migraine Trial Analysis

  • Pooled analysis of four randomized, placebo-controlled trials demonstrates rimegepant's statistically significant benefits in acute migraine treatment.
  • Rimegepant 75 mg showed superiority over placebo in achieving pain freedom and freedom from the most bothersome symptom at 2 hours post-dose.
  • The analysis supports early and consistent use of rimegepant, highlighting its flexibility for both acute and preventive migraine treatment.
  • Rimegepant's effectiveness leads to reduced use of rescue medications, potentially decreasing the risk of medication overuse headache and chronic migraine.

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