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Clinical Trial News

Daye's Diagnostic Tampon Shows Promise in STI and HPV Screening

• Daye's diagnostic tampon, designed for self-collection of vaginal and cervical fluids, aims to improve STI and HPV screening. • The STAMP trial demonstrated that women preferred the tampon over traditional swabs, with comparable outcomes to other self-screening methods. • The diagnostic tampon showed improved identification of bacterial vaginosis, chlamydia, gonorrhea, and trichomoniasis compared to alternative sampling methods. • Daye has commercialized the diagnostic tampon in the UK and the US, emphasizing convenient patient journeys to encourage more participation in screening programs.

Biotron's BIT225 Phase 2 Trial for COVID-19 Meets Safety Endpoint but Fails to Show Efficacy

  • Biotron's Phase 2 clinical trial of BIT225 for COVID-19 met its primary safety and tolerability endpoint, showing adverse events consistent with previous trials.
  • The trial did not meet the primary efficacy endpoint, as there were no statistically significant differences in SARS-CoV-2 nasal viral load reduction between the drug and placebo groups.
  • Four participants had undetectable levels of SARS-CoV-2 virus in their nasal samples on Day 1, impacting the overall efficacy analysis.
  • Biotron remains optimistic about BIT225's potential, citing promising preclinical data and the challenges of demonstrating efficacy in small trials with vaccinated individuals.

Zongertinib Shows Promise in HER2-Mutated NSCLC, Phase 3 Trial Underway

  • Zongertinib demonstrates significant activity in pretreated NSCLC patients with HER2 mutations, including those with brain metastases, showing a promising objective response rate.
  • The novel HER2-specific TKI, zongertinib, selectively binds to the HER2 tyrosine kinase domain, sparing EGFR, potentially reducing EGFR-mediated toxicities.
  • Clinical trial data from the Beamion LUNG-1 study reveals a manageable safety profile for zongertinib, with low rates of high-grade adverse events and no reported cases of ILD or pneumonitis.
  • A phase 3 confirmatory study, Beamion LUNG-2, is currently enrolling patients to compare zongertinib with standard of care as a first-line treatment for advanced HER2-mutant NSCLC.

Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

NCT04886804RecruitingPhase 1
Boehringer Ingelheim
Posted 7/2/2021

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

NCT03505710TerminatedPhase 2
Daiichi Sankyo
Posted 5/21/2018

Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

NCT06151574RecruitingPhase 3
Boehringer Ingelheim
Posted 2/9/2024

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

NCT05099172Active, Not RecruitingPhase 1
Bayer
Posted 10/25/2021

TIXiMED Receives FDA Clearance for Phase 1 Trial of Oral Type 1 Diabetes Drug, TIX100

  • TIXiMED Inc., a UAB startup, has received FDA clearance to begin clinical trials for TIX100, a novel oral drug for Type 1 diabetes.
  • TIX100's development stems from decades of research by Dr. Anath Shalev at UAB, aiming to ease the burden of insulin injections for T1D patients.
  • The oral availability of TIX100 represents a potential breakthrough in T1D treatment, offering a more convenient alternative to existing therapies.
  • This Phase 1 trial marks a significant step toward translating diabetes research into an improved treatment option for individuals with Type 1 diabetes.

Fulzerasib Shows Promise in KRAS G12C-Mutated NSCLC: Updated Phase 2 Results

  • Fulzerasib demonstrated a confirmed objective response rate of 49.1% in patients with advanced NSCLC harboring the KRAS G12C mutation.
  • The disease control rate with fulzerasib was 90.5%, with a median progression-free survival of 9.7 months in the studied population.
  • Fulzerasib was generally well-tolerated, with most treatment-related adverse events being Grade 1-2 in severity, indicating a manageable safety profile.
  • Approved in China, fulzerasib offers a new treatment option for NSCLC patients with KRAS G12C mutations who have received prior systemic therapy.

A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

NCT05005234RecruitingPhase 1
Innovent Biologics (Suzhou) Co. Ltd.
Posted 9/10/2021

Sacituzumab Govitecan Shows Promise in Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer

  • Sacituzumab govitecan demonstrated a 41.9% overall response rate in patients with extensive-stage small cell lung cancer (ES-SCLC) who had progressed after one prior line of therapy.
  • The TROPiCS-03 trial data showed a manageable safety profile, consistent with previous studies of sacituzumab govitecan, with no treatment discontinuations due to adverse events.
  • Median overall survival was 13.6 months, and the median progression-free survival was 4.4 months, indicating a clinically meaningful benefit in this patient population.
  • These encouraging results have led to the initiation of a randomized phase 3 study to further evaluate sacituzumab govitecan in relapsed ES-SCLC.

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

NCT03964727Active, Not RecruitingPhase 2
Gilead Sciences
Posted 10/15/2019

Subcutaneous Daratumumab Improves Patient Experience in Multiple Myeloma Treatment

  • A multi-country study reveals that subcutaneous daratumumab is perceived more favorably than the intravenous form by multiple myeloma patients.
  • Patients reported reduced anxiety, stress, and fatigue with the subcutaneous formulation, alongside increased comfort and well-being during treatment.
  • The subcutaneous route significantly decreased hospital stay duration, allowing patients more time for daily activities and improving their quality of life.
  • The study highlights the importance of considering patient preferences in treatment administration for improved adherence and overall outcomes.

Oxford Scientists Develop First Cancer Prevention Vaccine for Lynch Syndrome Patients

  • University of Oxford researchers are developing LynchVax, a first-of-its-kind vaccine designed to prevent cancers in patients with Lynch syndrome, a genetic condition that increases cancer risk by 80%.
  • The vaccine aims to train the immune system to recognize and destroy pre-cancerous cells before they develop into bowel, womb, and ovarian cancers.
  • Lynch syndrome affects an estimated one in 400 people in England and causes approximately 1,100 bowel cancer cases annually, primarily in patients under 50.
  • Cancer Research UK has awarded the research team £550,000 to analyze pre-cancerous cells and determine which components can be targeted by the immune system.

Real-World Evidence Shows Apixaban Reduces Major Bleeding Risk Compared to Rivaroxaban in Atrial Fibrillation Patients

Real World Evidence
  • Multiple large-scale real-world studies consistently demonstrate that apixaban is associated with 31-45% lower risk of major bleeding events compared to rivaroxaban in patients with non-valvular atrial fibrillation.
  • The COBRA-AF study, analyzing 177,866 propensity-matched patient pairs, found apixaban reduced the composite risk of major and clinically relevant non-major bleeding by 31% versus rivaroxaban.
  • Apixaban showed superior safety profiles across diverse patient populations, including those with chronic liver disease and bleeding history, while maintaining comparable stroke prevention efficacy.

Adaptive Deep Brain Stimulation Shows Promise in Parkinson's Disease

  • Adaptive deep brain stimulation (aDBS) significantly reduced the duration of bothersome symptoms in Parkinson's patients compared to conventional DBS.
  • Participants reported improved quality of life during aDBS sessions, with no significant adverse effects on mental health or sleep.
  • The aDBS system personalizes stimulation by measuring brain activity in real-time and adjusting stimulation levels accordingly.
  • Further research is needed to improve the accessibility and usability of aDBS systems for broader application in Parkinson's disease.

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