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Clinical Trial News

FDA Grants Breakthrough Therapy Designation to Lenvima-Keytruda Combination for Advanced Renal Cell Carcinoma

  • The FDA has granted Breakthrough Therapy Designation to Eisai's Lenvima (lenvatinib) combined with Merck's Keytruda (pembrolizumab) for treating patients with advanced and/or metastatic renal cell carcinoma.
  • The designation was based on results from Study 111, a multicenter Phase 1b/2 clinical trial evaluating the combination therapy in selected solid tumors including renal cell carcinoma.
  • This marks the second Breakthrough Therapy Designation for Lenvima and the twelfth for Keytruda, providing expedited development pathways and regulatory benefits.
  • The combination therapy is being jointly developed by Eisai and Merck as part of a broader strategic collaboration worth up to $5.76 billion.

Landiolol Demonstrates Rapid Rate Control in Atrial Fibrillation Patients

  • Landiolol, an ultra-short acting beta-blocker, effectively reduces heart rate in patients with tachycardic atrial fibrillation without significant blood pressure drop.
  • Studies show landiolol has higher cardioselectivity and potency compared to esmolol, requiring lower doses for effective heart rate control.
  • Clinical trials in both Asian and Caucasian populations confirm landiolol's rapid pharmacokinetic profile and similar efficacy in controlling supraventricular tachycardia.
  • Landiolol is well-tolerated, with dose-ranging studies determining optimal regimens for managing heart rate in emergency department settings.

Futura Medical's MED2005 Shows Promise as Rapid-Acting Topical Treatment for Erectile Dysfunction

  • Phase II trial of MED2005, a novel topical gel containing glyceryl trinitrate, demonstrates significant improvement in erectile function scores with onset within 10 minutes for 70% of participants.
  • The treatment showed an excellent safety profile with no serious adverse events reported, positioning it as a potential first-line therapy for erectile dysfunction.
  • Futura Medical plans to advance MED2005 to Phase III trials in 2018, exploring higher doses to enhance efficacy in moderate to severe erectile dysfunction cases.

PMV Pharma's Rezatapopt: First p53(Y220C) Stabilizer Shows Promise in Solid Tumors

  • PMV Pharma's rezatapopt is the first p53(Y220C) mutant stabilizer to enter clinical trials, targeting a common cancer mutation.
  • The drug is designed to bind to and stabilize the p53(Y220C) mutant, restoring its tumor-suppressing function in various solid tumors.
  • Early clinical results indicate potential efficacy across a range of solid tumors, marking a significant advancement in oncology.
  • Rezatapopt represents a novel approach to cancer therapy by directly addressing p53 mutations, present in over 50% of malignancies.

UK Survey Reveals Complex Landscape of Pharmaceutical Market Access Challenges

  • A comprehensive survey by UK PM Society's Market Access Interest Group reveals significant diversity in understanding market access across pharmaceutical industry and agencies.
  • Survey findings highlight major challenges including budget constraints, pricing pressures, and difficulties accessing key decision-makers within healthcare systems.
  • Results demonstrate a shifting emphasis toward process management in response to evolving NHS organizational structures and agendas.

Clinical Database Delays Significantly Impact Trial Timelines, Tufts Study Reveals

  • New research by Tufts Center for the Study of Drug Development reveals that 85% of life sciences organizations release clinical study databases after first patient enrollment, causing significant downstream delays.
  • Database release delays double patient data entry time from 5 to 10 days and increase database lock time by 75%, highlighting critical inefficiencies in clinical trial management.
  • Protocol changes are cited as the primary cause of database-build delays by 45% of respondents, while 77% report challenges with data loading into EDC systems.

Protection of the Human Gut Microbiome From Antibiotics

A clinical trial demonstrated that DAV132, a product containing activated charcoal, significantly reduces the exposure of the human gut microbiome to the antibiotic moxifloxacin (MXF) without affecting its plasma pharmacokinetics. The study, involving healthy volunteers, showed that DAV132 could protect the intestinal microbiota's richness and composition from the adverse effects of MXF, suggesting its potential to mitigate the long-term consequences of antibiotic treatments.

Safety and Efficacy Study of DAV132 in Healthy Volunteers

NCT02176005CompletedPhase 1
Da Volterra
Posted 3/1/2014

Leading Pharma Companies and Regulators to Convene at 10th Annual Adaptive Clinical Trials Conference

  • Industry leaders from AstraZeneca, Novartis, and Roche will gather in London to discuss innovations in adaptive clinical trial designs and digital technology integration in drug development.
  • The conference will feature key regulatory perspectives from EMA and MHRA representatives, focusing on critical topics including umbrella trials and basket trial assessments.
  • Sessions will explore the application of adaptive designs in developing personalized medicines and the impact of digital technology on modern clinical trials.

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