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Clinical Trial News

WCLC 2024: Study Reveals Multiple Hidden Burdens of Lung Cancer Treatment - Financial, Time, and Sexual Health Impacts

  • Research presented at WCLC 2024 shows 52% of lung cancer patients struggle with treatment costs, with minoritized and younger patients experiencing worse financial toxicity.
  • Time toxicity in clinical trials has significantly increased between 2015-2024 compared to the previous decade, particularly impacting patients participating in phase 1-3 studies.
  • A significant 63.4% of lung cancer patients report sexual dysfunction post-treatment initiation, with 88.4% expressing the importance of clinical assessment for these issues.

Poolbeg Pharma's POLB 001 Shows Promise in Preventing Cancer Immunotherapy-Induced CRS

  • Poolbeg Pharma's lead candidate, POLB 001, demonstrates efficacy in reducing cancer immunotherapy-induced Cytokine Release Syndrome (CRS) in preclinical models.
  • Independent research validates a potential $10 billion market opportunity for POLB 001 as a preventative therapy for cancer immunotherapy-induced CRS.
  • Poolbeg strengthens its patent portfolio and expands its focus on rare and orphan diseases, exemplified by an option agreement for tPTX to treat Behçet's Disease.
  • The company is advancing its oral GLP-1R agonist program, with clinical trials expected to begin in late 2024, targeting the growing obesity and diabetes market.

Brenus Pharma Secures $25 Million to Advance STC-1010 Cancer Vaccine Clinical Trials

  • Brenus Pharma has raised $25 million in a Series A funding round to advance clinical trials of its STC-1010 cancer vaccine.
  • The funding will support a Phase I/IIA trial of STC-1010 in metastatic colorectal cancer, utilizing the innovative STC 'Stimulated-Tumor-(ghost)-Cell' platform.
  • The STC platform aims to provide personalized cancer vaccines that anticipate and combat tumor resistance mechanisms, offering a new approach to immunotherapy.
  • Clinical trials are scheduled to commence by the end of 2024 in France, Belgium, and the USA, marking a significant step for Brenus Pharma.

FDA Formalizes Protocol for International Cancer Trials, Expanding Access to Novel Therapies

  • The FDA issued draft guidance formalizing its position on oncology clinical trials, encouraging trials beyond single countries like China.
  • The guidance aims to improve the generalizability and applicability of multiregional trial results to the U.S. population and medical practice.
  • This follows concerns about trials conducted solely in China and the need for diverse patient populations in cancer drug development.
  • Summit Therapeutics plans a global trial for its lung cancer therapy, which previously demonstrated success in a China-only study against Keytruda.

Valneva Seeks to Expand IXCHIQ Chikungunya Vaccine Label to Adolescents in Europe and Canada

  • Valneva has submitted label extension applications to the EMA and Health Canada for its chikungunya vaccine, IXCHIQ, to include adolescents aged 12-17.
  • The applications are supported by Phase 3 data demonstrating a 99.1% immune response in adolescents following a single dose of IXCHIQ.
  • The Health Canada submission includes data showing the vaccine's immune response sustained for 24 months in 97% of participants.
  • Valneva anticipates submitting data to the FDA to support potential label extensions in the U.S. later this year.

Baptist Health Achieves 52% Reduction in High-Risk Infusion Errors Through System-Wide Pump Standardization

  • Baptist Health successfully implemented a unified drug pump library across nine hospitals, streamlining operations and establishing consistent drug administration protocols to enhance patient safety.
  • The 18-month standardization initiative resulted in a 52% decrease in high-risk overrides from March 2023 to March 2024, while maintaining system guardrail compliance above 95%.
  • The health system consolidated eight separate drug pump libraries into one centralized intravenous infusion library, enabling better data-driven decision making and improved monitoring across facilities.

Hypofractionated Radiotherapy Shows Non-Inferior Lymphedema Risk in Early Breast Cancer

  • A phase 3 trial (HypoG-01) demonstrated that moderately hypofractionated locoregional radiation therapy is non-inferior to standard normofractionated radiation therapy for early breast cancer patients.
  • The 5-year cumulative incidence of arm lymphedema was comparable between the hypofractionated (33.3%) and normofractionated (32.8%) radiotherapy arms.
  • Hypofractionated radiotherapy did not show detrimental effects on survival outcomes, local recurrence-free survival, or distant disease-free survival.
  • The findings suggest a shift towards a 3-week hypofractionated regimen, even for nodal radiotherapy, potentially reducing treatment burden and healthcare costs.

Hypofractionated Vs. Conventional Regional Nodal Radiation Therapy for Patients with Invasive Breast Cancer

NCT02912312Active, Not RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 2/23/2017

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

NCT03127995Active, Not RecruitingNot Applicable
UNICANCER
Posted 9/1/2016

Autobahn Therapeutics Initiates Phase 2 Trial of ABX-002 for Major Depressive Disorder

  • Autobahn Therapeutics has commenced the AMPLIFY Phase 2 trial to evaluate ABX-002 as an adjunctive treatment for major depressive disorder (MDD).
  • The trial will enroll 230 adults with moderate-to-severe depression to assess the safety, tolerability, efficacy, and pharmacodynamic effects of ABX-002.
  • ABX-002 is a selective thyroid hormone beta receptor agonist designed to enhance the CNS benefits of thyroid hormone biology.
  • Topline data from the AMPLIFY trial is expected in the second half of 2025, with a second Phase 2 trial for bipolar disorder depression planned for late 2024.

Eli Lilly's EBGLYSS Receives FDA Approval Amidst Strategic Growth Initiatives

  • Eli Lilly's Q2 revenue surged by 36%, driven by new product launches, but was partially offset by supply constraints and a decline in Trulicity revenue.
  • The FDA approved Kisunla for Alzheimer's disease, highlighting Eli Lilly's strong R&D capabilities and pipeline advancements.
  • Eli Lilly is expanding access for Zepbound and acquired Morphic to strengthen its market position and pipeline of oral integrin therapies.
  • Despite a high P/E ratio, Eli Lilly's revenue is forecast to grow faster than the US market, indicating strong future growth potential.

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