Clinical Trial News
Sanofi Pivots R&D Strategy, Discontinues Diabetes Research to Focus on Novel Therapeutics
• Sanofi announces major strategic shift, discontinuing diabetes and cardiovascular R&D while prioritizing six potentially transformative therapies and its successful Dupixent franchise.
• The company's pipeline now features promising candidates including fitusiran for hemophilia, venglustat for rare diseases, and novel treatments for breast cancer and multiple sclerosis.
• Strategic realignment expected to generate €2 billion in cost savings, enabling increased investment in pipeline development and wider profit margins.
Tech-Enabled Solutions Target Racial Disparities in Clinical Trial Participation
• Less than 3% of eligible US patients participate in clinical trials, with even lower rates among ethnic minorities, highlighting a critical gap in medical research representation.
• Reveles Clinical Services partners with Black Men in White Coats to increase diversity among principal investigators, addressing trust barriers in minority communities.
• Decentralized clinical trials utilizing telehealth, wearables, and remote monitoring are being implemented to overcome geographical and access barriers for underserved populations.
Early Disease Screening Programs Show Significant Impact on Chronic Disease Prevention
• Annual health screenings identified 1,185 previously unrecognized cases of prediabetes, 287 cases of diabetes, and 73 cases of chronic kidney disease per 10,000 people screened.
• Early detection and appropriate medical care could prevent 210 diabetes cases and delay 34 cases of end-stage kidney disease over 5 years per 1,000 cases identified.
• Employer-sponsored screening programs demonstrate potential for substantial healthcare cost savings through early disease identification and intervention.
Apple Launches Research App with Three Major Health Studies Focusing on Women's Health, Heart Disease, and Hearing
• Apple has introduced its Research app in the US, enabling iPhone and Watch users to participate in studies on women's health, cardiovascular conditions, and hearing impacts, with leading research institutions.
• The women's health study, partnering with Harvard University and NIEHS, will investigate connections between menstrual cycles and conditions like PCOS, while the heart study with Brigham and Women's Hospital will monitor for AFib and heart disease.
• The app emphasizes data privacy and user control, allowing participants to manage their data sharing preferences while contributing to multiple studies simultaneously through a unified platform.
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.
Highlighted Clinical Trials:
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.
Highlighted Clinical Trials:
Ottawa Hospital Research Institute
Posted 10/1/2016
University of Washington
Posted 6/1/2016
NHS Blood and Transplant
Posted 6/1/2015
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.