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Clinical Trial News

Olaparib-Temozolomide Combination Fails to Improve Outcomes in Advanced Uterine Leiomyosarcoma

  • The phase 2/3 Alliance A092104 trial evaluating olaparib plus temozolomide in advanced uterine leiomyosarcoma failed to meet its primary progression-free survival endpoint compared to standard care.
  • The combination showed a median PFS of 3.2 months versus 5.5 months with investigator's choice of pazopanib or trabectedin, leading to early trial closure for futility.
  • Despite promising early-phase data, the study highlights the challenge of demonstrating superiority over existing therapies in this rare cancer population.
  • The trial will be closed on October 1, 2025, with researchers emphasizing the need to better identify which patients might benefit from molecularly targeted approaches.

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

NCT05432791Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 3/30/2023

Moderna Seeks External Partners to Fund Late-Stage Vaccine Trials for Latent Virus Programs

  • Moderna is actively seeking partnerships with pharmaceutical companies and financial firms to fund late-stage trials for its latent virus vaccine portfolio, including programs targeting Epstein-Barr virus, herpes simplex virus, and varicella-zoster virus.
  • The company has paused internal spending on these programs and aims to advance them to Phase 3 trials without additional capital expenditure, leveraging existing manufacturing capacity.
  • This strategic financing approach follows Moderna's earlier collaboration model with Blackstone on flu vaccine development and supports the company's goal to return to profitability by 2028.
  • Despite having over $8.5 billion in cash reserves, Moderna prioritizes capital efficiency and securing optimal partnership structures over speed in deal-making.

University at Buffalo Develops Novel Non-Opioid Molecule for Long-Lasting Chronic Pain Relief

  • University at Buffalo researchers have developed a lipidated peptide molecule that provides chronic pain relief for up to three weeks with a single local injection, targeting the Magi-1/NaV1.8 protein interaction.
  • The novel approach disrupts the scaffolding protein Magi-1's interaction with pain-transmitting NaV1.8 ion channels, causing channel degradation and blocking pain transmission without affecting touch sensation.
  • Preclinical studies published in the journal Pain demonstrate the molecule's effectiveness in both animal models and human pain neurons, with the research team now seeking partners for clinical trials.
  • The development represents a significant advancement in non-opioid pain management, supported by NIH's HEAL Initiative and being commercialized through startup company Channavix Therapeutics LLC.

Sandoz Completes $11.2 Billion Spin-Off from Novartis, Becomes Independent Generics Leader

  • Sandoz successfully separated from Novartis and began trading independently on the SIX Swiss Exchange at CHF 24 per share, valuing the company at approximately $11.2 billion.
  • The newly independent company reported strong financial performance with $4.8 billion in first-half sales, up 8% at constant currencies, and operating profit of $1 billion.
  • Sandoz management expects to add $3 billion in annual sales from new product launches, primarily biosimilars and complex generics, following the separation.
  • The spin-off allows Novartis to focus entirely on innovative medicines while positioning Sandoz as a global leader in generics and biosimilars serving 500 million patients worldwide.

Ryght AI Secures $3M Seed Funding and Expands Academic Partnerships to Accelerate Clinical Trial Site Selection

AI
  • Ryght AI raised $3 million in seed funding led by Foothill Ventures to advance its AI-powered clinical trial platform that creates digital twins of over 100,000 research sites worldwide.
  • The company announced new partnerships with academic medical centers including Emory University, West Virginia University, and West Clinic, joining previously established collaborations with USC Keck School of Medicine and Medical College of Wisconsin.
  • Ryght AI's platform addresses critical industry inefficiencies where sponsors spend up to $50,000 activating a single site and $50,000-$500,000 enrolling each patient, with 55% of trials failing due to poor site feasibility.
  • The AI-driven solution reduces traditional feasibility timelines from several months to less than three weeks through automated workflows and real-time site performance data.

FDA Accepts Tamarack Biotics' UV Light Milk Treatment Technology as Safe Alternative to Traditional Pasteurization

FDA Approval
  • Tamarack Biotics secured FDA acceptance for its TruActive® UV light-based milk treatment process, marking the first scientifically verified safe raw milk equivalent in the dairy industry.
  • The innovative technology eliminates harmful pathogens while preserving bioactive compounds like enzymes and immunity-supporting proteins that are typically destroyed by heat-based pasteurization.
  • A UC Davis clinical trial demonstrated that milk protein concentrate treated with TruActive® restored immune function in aging populations, while European studies showed raw milk consumption protected children from allergies.
  • The FDA approval initially covers powdered dairy ingredients, with liquid raw milk treatment expected as early as 2027.

FDA Approves New Tablet Formulation of BRUKINSA for All Indications, Reducing Pill Burden for B-Cell Cancer Patients

Drug ApprovalOncology
  • The U.S. FDA has approved a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications, reducing daily pill burden from four capsules to two tablets while maintaining the same 320 mg daily dose.
  • The new 160 mg tablets demonstrate bioequivalence to the existing capsules based on Phase 1 crossover studies and offer improved patient convenience with smaller size and film coating for easier swallowing.
  • BRUKINSA has achieved market leadership as the top BTK inhibitor in the U.S. and leads in new chronic lymphocytic leukemia patient starts across all therapy lines.
  • The tablet formulation will replace capsules starting in October 2025, with European regulatory approval expected later this year.

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

NCT02604511CompletedPhase 2
Dana-Farber Cancer Institute
Posted 1/1/2016

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

NCT01722487CompletedPhase 3
Pharmacyclics LLC.
Posted 3/1/2013

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT01578707CompletedPhase 3
Pharmacyclics LLC.
Posted 6/1/2012

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

NCT02165397CompletedPhase 3
Pharmacyclics LLC.
Posted 7/7/2014

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

NCT05547399CompletedPhase 1
BeiGene
Posted 6/7/2022

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

NCT01109069CompletedPhase 2
Pharmacyclics LLC.
Posted 6/1/2010

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

NCT03332017CompletedPhase 2
BeiGene
Posted 11/14/2017

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

NCT01614821CompletedPhase 2
Dana-Farber Cancer Institute
Posted 5/1/2012

Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

NCT05767398CompletedPhase 1
BeiGene
Posted 3/7/2023

Aspirin Shows No Benefit and Potential Harm in Colorectal Cancer Liver Metastases, Phase 3 Trial Finds

  • Daily adjuvant aspirin at 160 mg failed to improve disease-free survival in patients with colorectal cancer liver metastases compared to placebo in the randomized phase 3 ASAC trial.
  • The aspirin group showed a numerically higher risk for death that nearly reached statistical significance, with more adverse events and serious complications.
  • Results indicate the protective effects of aspirin observed in non-metastatic colorectal cancer do not translate to patients with liver metastases.
  • Researchers plan subgroup analyses for PIK3CA, PTEN, and KRAS mutations to identify potential patient populations who might benefit from aspirin therapy.

Aspirin in Colorectal Cancer Liver Metastases

NCT03326791Active, Not RecruitingPhase 2
Oslo University Hospital
Posted 12/15/2017

Adjuvant Low Dose Aspirin in Colorectal Cancer

NCT02647099Active, Not RecruitingPhase 3
Anna Martling
Posted 4/7/2016

T1D Exchange to Present 13 Real-World Data Studies at ADA 2025 Scientific Sessions

Real World Evidence
  • T1D Exchange will present 13 real-world data studies at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025.
  • The studies focus on advances in diabetes screening, mental health, health equity, and early intervention, with particular emphasis on continuous glucose monitoring adoption in type 2 diabetes patients using GLP-1 therapy.
  • The research draws from T1D Exchange's Quality Improvement Collaborative network of over 60 endocrinology clinics treating more than 150,000 patients and their Registry of over 20,000 type 1 diabetes participants.
  • The organization has contributed to more than 100 publications in leading medical journals since 2020, strengthening its leadership in diabetes research and care improvement.

OKYO Pharma's Eye Pain Drug Trial Ends Early, Analysts Raise Price Target 60% on Accelerated Timeline

  • OKYO Pharma's Phase 2 trial for urcosimod, a potential first-in-class treatment for neuropathic corneal pain, closed early after treating 17 patients instead of the planned 48, with top-line results now expected in Q3 2025.
  • Goldman Small Cap Research raised its price target for OKYO shares to $8 from $5, citing the early trial closure as potentially shortening the development pathway and accelerating time to market.
  • The drug targets neuropathic corneal pain, a debilitating condition with no FDA-approved therapies and an estimated market opportunity exceeding $6.4 billion.
  • OKYO's shares have nearly doubled since the start of 2025, driven by clinical progress and the FDA's Fast Track designation for urcosimod.

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