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Clinical Trial News

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.

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT03274492Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/16/2017

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.

Psyence Biomed to Acquire Clairvoyant Therapeutics, Expanding Psilocybin Pipeline for AUD

  • Psyence Biomed has signed a conditional agreement to acquire Clairvoyant Therapeutics, a developer of psilocybin-based therapeutics, for $500,000 in shares and potential milestone payments.
  • The acquisition aims to broaden Psyence Biomed's pipeline by including a synthetic psilocybin candidate for Alcohol Use Disorder (AUD), complementing their existing nature-derived psilocybin program.
  • Clairvoyant is currently conducting a Phase IIb clinical trial of its psilocybin candidate for AUD, with topline data expected in early 2025.
  • The deal could position Psyence Biomed as a leader in psychedelic-based therapeutics, with potential for commercialization in the underserved mental health market.

Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

NCT05646303Active, Not RecruitingPhase 2
Clairvoyant Therapeutics
Posted 5/2/2022

Aurinia Pharmaceuticals Initiates Phase Ia Trial of AUR200 for Autoimmune Diseases

  • Aurinia Pharmaceuticals has dosed the first subject in a Phase Ia trial of AUR200, an IgG4 Fc-fusion protein, for autoimmune diseases.
  • The trial aims to assess the safety, tolerability, pharmacokinetics, and biomarker changes of AUR200 in healthy volunteers, with results expected in the first half of next year.
  • AUR200 targets both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), crucial cytokines in B-cell regulation.
  • Preclinical studies showed AUR200 reduced disease activity markers and improved survival in a lupus mouse model, suggesting potential as a best-in-class treatment.

Marcus Foundation Funds $25.9 Million REACH Trial to Revolutionize Deep Hemorrhagic Stroke Treatment

  • The Marcus Foundation has awarded $25.9 million to fund the REACH trial, aimed at improving treatment for intracerebral hemorrhage (ICH), a severe form of hemorrhagic stroke.
  • The REACH trial will investigate minimally invasive parafascicular surgery (MIPS) for deep ICH, specifically within the anterior basal ganglia, where current surgical treatments lack proven effectiveness.
  • The study will enroll approximately 600 patients across 60 stroke centers nationwide, starting in December 2024, to optimize MIPS technique and establish new treatment guidelines.
  • The REACH registry will build a comprehensive data repository to guide future clinical practices and promote broader adoption of MIPS for patients with spontaneous ICH.

FDA Grants Fast Track Status to Treg Therapy for Multiple Sclerosis and Orphan Drug Designation to Gene Therapy for Retinitis Pigmentosa

  • Abata Therapeutics' ABA-101, an autologous Treg cell therapy, received FDA Fast Track designation for progressive multiple sclerosis, aiming to reduce inflammation in the central nervous system.
  • Orgenesis Inc. reported encouraging data from a real-world study of ORG-101, a CD19 CAR-T therapy, showing high complete response rates in both adult and pediatric patients with B-cell ALL.
  • Skyline Therapeutics' SKG1108, a gene therapy for retinitis pigmentosa, received FDA Orphan Drug Designation, offering potential vision restoration by delivering light-activatable proteins to the retina.

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