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Clinical Trial News

European Regulators Approve Lenacapavir, First Twice-Yearly HIV Prevention Injection

Drug Approval
  • The European Medicines Agency's advisory committee issued a positive opinion on lenacapavir for pre-exposure prophylaxis, marking the final regulatory hurdle before formal approval by the European Commission.
  • Lenacapavir demonstrated 100% efficacy in preventing HIV transmission during clinical trials, offering a twice-yearly injection alternative to daily prevention pills.
  • The approval comes as HIV cases rose 11.8% in Europe in 2023, with over 24,700 new diagnoses across the EU, Iceland, Liechtenstein, and Norway.
  • Gilead Sciences has committed to making generic versions available in 120 low-income countries, though concerns remain about equitable global access.

China Grants Conditional Approval to Seaweed-Derived Alzheimer's Drug Oligomannate

Drug Approval
  • Chinese regulators have granted conditional approval to Oligomannate, a seaweed-derived drug for mild to moderate Alzheimer's disease, marking the first new Alzheimer's therapy approval in nearly two decades.
  • The drug, developed by Shanghai Green Valley Pharmaceuticals, showed cognitive improvements in a Phase 3 trial of 818 patients with benefits observed as early as four weeks.
  • Unlike traditional approaches targeting brain protein buildup, Oligomannate works by modulating the gut microbiome to reduce neuroinflammation associated with Alzheimer's disease.
  • The company plans to launch a global Phase 3 trial in 2020 with sites in the United States, Europe, and Asia to seek international regulatory approval.

CDK4/6 Inhibitors Plus Endocrine Therapy Significantly Improve Outcomes in Advanced Breast Cancer

• A meta-analysis of eight clinical trials demonstrates that CDK4/6 inhibitors combined with endocrine therapy significantly prolong progression-free survival in advanced breast cancer patients. • The combination therapy also shows a statistically significant improvement in overall survival compared to endocrine therapy alone, with manageable adverse events. • The study identifies a notable increase in bone marrow suppression, particularly neutropenia and leukopenia, associated with the combined treatment, but without increased gastrointestinal toxicity. • Findings support the use of CDK4/6 inhibitors with endocrine therapy as a salvage treatment, highlighting the need for longer follow-up to fully evaluate long-term overall survival benefits.

EU Approves Astellas' Xospata for FLT3-Positive AML, Showing Survival Benefit Over Chemotherapy

  • The European Commission has granted approval for Xospata (gilteritinib) to treat relapsed or refractory FLT3-positive acute myeloid leukemia, demonstrating a 3.7-month survival advantage over standard chemotherapy.
  • FLT3 mutations, present in approximately 30% of AML patients, are associated with poor prognosis and shorter survival, making this targeted therapy a significant advancement in treatment.
  • Astellas' Xospata demonstrates broader mutation coverage by targeting both ITD and TKD FLT3 mutations, positioning it advantageously against competitor drugs in the European market.

Replimune Enrolls First Patient in Phase 1 Clinical Trial of RP2 for Advanced Cancer

Replimune Group Inc. has announced the enrollment of the first patient in its Phase 1 clinical trial of RP2, an oncolytic immuno-gene therapy, both as a single agent and in combination with Opdivo (nivolumab) for treating advanced solid tumors. This trial aims to assess the safety, tolerability, and optimal dosage of RP2, which expresses an anti-CTLA-4 antibody-like protein to enhance immune response against cancer.

NIH Launches Influenza Human Challenge Study to Advance Vaccine Development

  • The National Institute of Allergy and Infectious Diseases (NIAID) has initiated a clinical trial where healthy adults will be deliberately infected with influenza virus under controlled conditions at four research sites across the US.
  • The study aims to assess how pre-existing influenza antibodies affect the timing, magnitude, and duration of flu symptoms, with up to 80 volunteers aged 18-50 participating in the trial.
  • Participants will receive a nasal spray containing the InfluenzaA/Bethesda/MM2/H1N1 strain and remain under observation for at least seven days, with preliminary results expected by May 2020.

H1N1v Virus Challenge Study in Healthy Subjects

NCT04044352CompletedPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)
Posted 10/22/2019

The TREATT Trial: Evaluating Tranexamic Acid in Haematological Malignancies

The TREATT trial investigates the use of tranexamic acid (TXA) in patients with haematological malignancies to reduce bleeding and the need for platelet transfusions. This multinational, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of TXA during periods of severe thrombocytopenia.

American Trial Using Tranexamic Acid in Thrombocytopenia

NCT02578901CompletedPhase 3
University of Washington
Posted 6/1/2016

TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

NCT03136445CompletedPhase 3
NHS Blood and Transplant
Posted 6/1/2015

Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study

NCT02650791CompletedPhase 3
Ottawa Hospital Research Institute
Posted 10/1/2016

Final Analysis from RESONATE: Up to Six Years of Follow-up on Ibrutinib vs Ofatumumab in CLL

The final analysis of the RESONATE study, with up to six years of follow-up, highlights the efficacy and safety of ibrutinib compared to ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ibrutinib demonstrated significantly longer progression-free survival (PFS) and overall survival (OS) benefits, especially in high-risk patients. The study also noted the long-term tolerability of ibrutinib, with a decrease in adverse events over time.

MRD Negativity as a Surrogate Endpoint for PFS in Newly Diagnosed Multiple Myeloma

  • Meta-analysis of six randomized trials with 3,283 NDMM patients supports MRD negativity as a surrogate endpoint for progression-free survival (PFS).
  • Treatment effect on MRD negativity strongly correlates with the treatment effect on PFS, indicating its potential to predict clinical benefit.
  • The study suggests MRD status can be used in clinical trials for NDMM, potentially accelerating drug development and approval processes.
  • These findings align with FDA workshop guidelines, supporting MRD negativity as a Level 3 surrogate endpoint for PFS in NDMM.

A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma

NCT00531453CompletedPhase 2
Millennium Pharmaceuticals, Inc.
Posted 10/1/2007

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