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Clinical Trial News

Deuterium-Depleted Water Shows Promise in Regulating Cancer Cell Growth

  • Two review papers analyzing nearly 200 studies suggest that deuterium-depleted water (DDW) can inhibit tumor cell proliferation and suppress cancer cell migration, potentially reducing metastasis.
  • DDW may influence cell cycle regulation by promoting autophagy, apoptosis, and senescence, with observed changes in gene expression related to cancer development.
  • A Phase 2 trial showed that prostate cancer patients receiving DDW alongside conventional therapy experienced a significantly greater reduction in prostate size compared to those receiving a placebo.
  • HYD LLC is seeking partnerships to conduct a Phase II/III clinical study to evaluate DDW's efficacy in treating cancers like glioblastoma, lung, breast, or prostate cancer.

Azithromycin Reduces Childhood Mortality in Niger: Study Shows Twice-Yearly Distribution Effective for Children Aged 1-59 Months

  • A randomized cluster trial in rural Niger showed that twice-yearly azithromycin distribution significantly reduced all-cause mortality in children aged 1-59 months.
  • The study found no significant reduction in mortality when azithromycin distribution was limited to infants aged 1-11 months.
  • The findings suggest that broader azithromycin distribution strategies may be more effective in reducing childhood mortality in high-mortality settings.
  • The research highlights the potential of azithromycin as a tool to combat childhood mortality in Sub-Saharan Africa.

Resmetirom: Duke Research Leads to First FDA-Approved Drug for MASH Liver Disease

  • Resmetirom, a novel drug developed with Duke University research, has gained FDA approval as the first treatment for metabolic dysfunction-associated steatohepatitis (MASH).
  • The drug targets thyroid hormone pathways to stimulate fat breakdown in the liver, addressing a critical need for the estimated 115 million people worldwide affected by MASH.
  • While only 30% of trial participants benefited after one year and the treatment costs $50,000 annually, resmetirom marks a significant advancement, with hopes for expanded treatment options and reduced costs through further research.
  • Research indicates that interest in MASH is growing, with resmetirom and similar drugs potentially working alongside other therapies to combat the disease and alleviate the health burden associated with advanced liver and cardiovascular complications.

Lenvatinib and Pembrolizumab Combination Shows Promise in Non-Clear Cell Renal Cell Carcinoma Subtypes

  • Lenvatinib plus pembrolizumab demonstrates a 54% overall response rate and a median progression-free survival of 17.4 months in papillary renal cell carcinoma.
  • For chromophobe RCC, lenvatinib/pembrolizumab shows a 34.5% ORR and a median PFS of 26.2 months, suggesting combination therapy is superior to single-agent treatment.
  • IO-TKI combinations, including lenvatinib/pembrolizumab, exhibit the highest response rates (around 25%) in translocation RCC, supporting their use in this population.

Cytonics Completes Enrollment in Phase 1 Trial of CYT-108 for Knee Osteoarthritis

  • Cytonics has completed enrollment for its Phase 1 clinical trial of CYT-108, a novel recombinant protease inhibitor for osteoarthritis (OA).
  • The trial is a multi-center, double-blind, randomized controlled trial (RCT) evaluating the safety and efficacy of CYT-108 in patients with mild-to-moderate knee OA.
  • CYT-108 is designed as a disease-modifying therapy, differentiating itself through highly specific and broad-spectrum protease inhibition activity.
  • Top-line results from the Phase 1 study are expected in the second quarter of 2025, with plans to file an IND with the FDA.

Akeso Highlights Bispecific Antibody Data at ESMO 2024, Demonstrating Promising Results in Multiple Cancers

  • Akeso will present data from 13 clinical studies at ESMO 2024, featuring cadonilimab, ivonescimab, and ligufalimab across various advanced cancers.
  • Ivonescimab, alone or with ligufalimab, shows significant ORR, DCR, and PFS in MSS-type mCRC, surpassing current standards, particularly as a first-line treatment.
  • In first-line TNBC, ivonescimab combined with chemotherapy demonstrates robust ORR, DCR, and meaningfully significant PFS, even in PD-L1 negative patients.
  • Anlotinib plus penpulimab shows promise as a first-line therapy for advanced hepatocellular carcinoma compared to sorafenib, to be presented as a late-breaking abstract.

Novel Cell-Free DNA Assays Enhance MRD Detection in Lymphoma Subtypes

  • New cell-free DNA assays are improving minimal residual disease (MRD) detection in lymphoma, extending utility across various subtypes.
  • IgHTS assays track tumor-specific clonotypes, while panel-based assays like CAPP-Seq offer improved sensitivity by tracking dozens of mutations.
  • Emerging assays like PhasED-seq and MAESTRO maximize tumor reporters, potentially adapting therapy based on ctDNA results.
  • Clinical trials are now adapting therapy based on circulating tumor DNA (ctDNA) results, showcasing the impact of these advancements.

Cardiff Oncology's Onvansertib Enters Phase 2 Trial for KRAS/NRAS-Mutated Metastatic Colorectal Cancer

  • Cardiff Oncology has initiated a Phase 2 randomized trial (ONSEMBLE) of onvansertib in patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC).
  • The company's Scientific Advisory Board (SAB) has been expanded with full membership, enhancing expertise for clinical development.
  • Fairooz Kabbinavar, MD, FACP, has been appointed as Chief Medical Officer, bringing extensive experience to guide clinical programs.
  • Cardiff Oncology's financial runway extends into 2025, supported by approximately $97 million in cash, cash equivalents, and short-term investments.

Shingles Episodes Linked to 20% Higher Risk of Cognitive Decline, Brigham Study Reveals

  • New research from Brigham and Women's Hospital demonstrates that experiencing shingles is associated with a 20% increased risk of subjective cognitive decline in both men and women.
  • The study, analyzing data from over 149,000 participants across three cohorts, found an elevated risk particularly among male carriers of the APOE4 gene, known for its connection to cognitive impairment.
  • Researchers highlight the potential of shingles vaccination as a preventive measure against both the viral infection and subsequent cognitive decline, emphasizing its public health significance.

Vor Bio's Trem-cel Plus Mylotarg Shows Promise in Relapsed/Refractory AML

  • Vor Bio announced positive Phase 1/2 clinical data for trem-cel followed by Mylotarg in relapsed/refractory AML, demonstrating reliable engraftment.
  • The treatment showed shielding from Mylotarg's on-target toxicity and broadened the therapeutic window, suggesting early patient benefit.
  • VCAR33ALLO, another asset, showed encouraging biomarker data at the lowest dose in relapsed/refractory AML post-transplant patients.
  • Vor Bio plans to discuss a pivotal trial design with the FDA for trem-cel + Mylotarg by year-end and is advancing VADC45, a new preclinical asset.
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