Clinical Research Weekly Brief: May 6–12, 2025
Stay informed with the latest developments in clinical research from the past week. This summary highlights key news and trends shaping the field, from advancements in myelofibrosis treatment and ALS research to breakthroughs in ovarian and bladder cancer therapies, pediatric growth disorders, atopic dermatitis, and type 1 diabetes studies.
Key Clinical Research News
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Karyopharm Reports Positive Myelofibrosis Trial Update Alongside Q1 2025 Financials
Karyopharm Therapeutics announced positive results from the Phase 3 SENTRY trial for myelofibrosis, indicating the study will proceed as planned after a successful futility analysis. Additionally, new data from a separate group of myelofibrosis patients treated with selinexor monotherapy showed promising improvements in spleen volume, symptoms, hemoglobin levels, and potential disease modification. These findings suggest selinexor could be a beneficial treatment option for myelofibrosis patients, and the company is exploring its combination with ruxolitinib for newly diagnosed patients.
Published: May 12, 2025
Karyopharm Reports First Quarter 2025 Financial Results and Announces New Data in Myelofibrosis that Further Suggests Selinexor May Lead to Meaningful Spleen Volume Reduction, Symptom Improvement, Hemoglobin Stabilization and Disease Modification - May 12 -
BrainStorm Highlights NurOwn Biomarker Insights at ALS Drug Development Summit
BrainStorm Cell Therapeutics presented new biomarker data related to their investigational cell therapy, NurOwn (debamestrocel), for ALS at the 4th Annual ALS Drug Development Summit. The research involved analyzing cerebrospinal fluid samples from ALS patients treated with NurOwn, aiming to understand the therapy’s mechanism and impact. The findings explored the correlation between specific biomarker pathways and clinical outcomes, also addressing the variability of ALS and NurOwn’s potential differential effects across patient subgroups. These insights are crucial for refining patient selection and optimizing the design of their upcoming Phase 3b clinical trial under a Special Protocol Assessment agreement with the FDA.
Published: May 6, 2025
BrainStorm to Present Biomarker Insights Supporting NurOwn's Mechanism of Action and Clinical Impact at the 2025 ALS Drug Development Summit -
Corvus Pharmaceuticals Shares Interim Findings from Phase 1 Atopic Dermatitis Trial
Corvus Pharmaceuticals announced interim data from its Phase 1 trial of soquelitinib, an ITK inhibitor, in patients with moderate to severe atopic dermatitis. The interim analysis of the first three dosage groups showed that soquelitinib was generally well tolerated with no dose-limiting toxicities. Biomarker studies revealed a reduction in pro-inflammatory cytokines and a correlation with improved Eczema Area and Severity Index (EASI) scores in patients treated with soquelitinib, suggesting a potential therapeutic benefit.
Published: May 8, 2025
https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo/ -
Breakthrough T1D Foundation Shares Updates on Currently Enrolling Clinical Trials for Type 1 Diabetes
The Pacific Northwest Chapter of the Breakthrough T1D Foundation highlighted several ongoing clinical trials and studies seeking participants with type 1 diabetes. These studies, conducted at institutions like the Benaroya Research Institute and the University of Washington, are investigating various approaches, including frexalimab and JAK inhibitors for preserving insulin production in newly diagnosed individuals, and semaglutide for kidney complications in adults with T1D. The foundation encourages interested individuals to contact the research centers for more information on eligibility.
Published: May 6, 2025
Clinical Trials and Studies Now Enrolling! - Pacific Northwest Chapter
Tools & Tips
- RealTime eClinical Platform:
This integrated platform combines CTMS, eSource, eReg/eISF, patient engagement tools, and a payment system to streamline clinical trial site management, enhance efficiency, and improve data quality. - Florence Healthcare Platform:
Offering a suite of solutions including eBinders, eNcounter, StudyOrganizer, eConsent, SiteLink, eTMF, and ParticipantLink, this platform aims to optimize workflows for research sites, sponsors, and CROs.
Fun Fact
Did you know? One of the earliest examples of a controlled experiment resembling a clinical trial is found in the Book of Daniel, where a dietary comparison was made between individuals consuming meat and wine versus those on a vegetarian diet of pulses and water.
We’d love to hear from you!
Have you participated in any clinical research events or utilized new clinical research tools recently? Share your experiences or insights with us—we’re featuring selected community voices in next week’s edition.