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ViPOR Regimen Shows Durable Remissions in Relapsed DLBCL Subtypes

  • A phase Ib/II study of the ViPOR regimen shows durable remissions in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients with specific molecular subtypes.
  • The ViPOR regimen consists of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide, targeting multiple key survival pathways in B-cell lymphoma.
  • In non-GCB DLBCL patients, 39% were alive and without disease evidence at 2 years, with some in continued remission beyond 5 years, suggesting potential cures.
  • The ViPOR regimen offers a cost-effective alternative to CAR T-cell therapy, priced at $180,000 for six cycles compared to $500,000-$1 million for CAR T-cell therapy.

Nomic and PICI Partner to Profile Immunotherapy Responses in RADIOHEAD Study

  • Nomic Bio and the Parker Institute for Cancer Immunotherapy (PICI) are collaborating to analyze protein biomarkers in immunotherapy patients.
  • Nomic's nELISA platform will be used to quantify hundreds of proteins in blood samples from PICI's RADIOHEAD study.
  • The project aims to understand how patients respond to immune checkpoint inhibitor (ICI) treatment and identify resistance mechanisms.
  • Data from the study is expected to be published in early 2025, potentially improving precision medicine approaches.

Ruxolitinib Cream Prescriptions for Vitiligo Issued in Greater Bay Area, China; NDA Accepted by NMPA

  • China Medical System Holdings (CMS) announces the first prescriptions of ruxolitinib cream for vitiligo in the Greater Bay Area.
  • The prescriptions were issued at designated hospitals following approval via the "Hong Kong and Macau Medicine and Equipment Connect" policy.
  • The National Medical Products Administration of China (NMPA) has accepted the New Drug Application (NDA) for ruxolitinib cream for vitiligo.
  • Real-world studies in China showed positive efficacy and safety, aligning with global pivotal clinical study outcomes for vitiligo treatment.

Cardiol Therapeutics Completes Enrollment in Phase II Acute Myocarditis Trial

  • Cardiol Therapeutics has achieved full enrollment for its Phase II clinical trial investigating a novel therapy for acute myocarditis.
  • The trial assesses the safety and efficacy of CardiolRx, a pharmaceutically produced cannabidiol formulation, in reducing myocardial inflammation.
  • Completion of enrollment marks a significant milestone in the development of a potential new treatment option for this inflammatory heart condition.
  • The study's results could provide critical insights into the therapeutic potential of cannabidiol in cardiovascular diseases.

Optimizing Neoadjuvant Immunotherapy Strategies in Colorectal Cancer

  • Neoadjuvant immunotherapy shows promise in treating dMMR/MSI-H colorectal cancer, leading to high pathological response rates and potential organ preservation.
  • Research explores biomarkers like TMB and PD-L1 to predict immunotherapy response, aiming to personalize treatment and improve outcomes.
  • Combination therapies and novel agents like botensilimab are being investigated to enhance efficacy in both dMMR/MSI-H and pMMR/MSS colorectal cancers.
  • Ongoing trials are evaluating the role of neoadjuvant immunotherapy in locally advanced rectal cancer, with a focus on balancing efficacy and toxicity.

Low-Intensity Therapy Shows Positive Outcomes for Pediatric Leukemia Subtypes

  • St. Jude Children's Research Hospital trials show genomics and early treatment response can guide risk classification in B-cell acute lymphoblastic leukemia (B-ALL).
  • Patients with ETV6::RUNX1 and high-hyperdiploid B-ALL achieved positive outcomes with low-intensity chemotherapy, reducing side effects like thrombosis and pancreatitis.
  • The study highlights the potential for personalized treatment approaches based on individual patient characteristics, improving event-free survival rates.
  • Researchers emphasize the importance of minimizing treatment intensity to reduce long-term health issues in pediatric cancer patients.

Synergia Medical Implants First Patients with Novel Neurostimulator for Epilepsy

  • Synergia Medical has implanted its NAO.VNS device in first-in-human study participants with drug-resistant epilepsy, testing a novel neurostimulation technology.
  • The AURORA trial, conducted across sites in Belgium and Germany, will evaluate the safety and efficacy of Synergia's vagus nerve stimulation therapy.
  • Synergia's device uses optical fibers instead of metal wires, potentially allowing patients to undergo MRI scans, which are typically restricted with conventional devices.
  • The global neuromodulation device market is projected to reach nearly $11 billion by 2033, with vagus nerve stimulation contributing significantly to this growth.

Low-Intensity rTMS Shows Promise in Enhancing Myelin Repair in Multiple Sclerosis Models

  • Low-intensity repetitive transcranial magnetic stimulation (LI-rTMS) boosts myelin repair capacity of oligodendrocytes in lab models of multiple sclerosis.
  • LI-rTMS increases myelin production by both new and mature oligodendrocytes, particularly in the corpus callosum, enhancing brain communication pathways.
  • The treatment improves myelin efficiency by increasing the length and thickness of myelin sections, suggesting potential for restoring nerve function.
  • A Phase 2 clinical trial is underway to assess the effectiveness of LI-rTMS in promoting myelin repair and improving clinical outcomes in MS patients.

Cassava Sciences' Simufilam Maintains Safety Profile in Phase 3 Alzheimer's Trials

  • An independent Data and Safety Monitoring Board (DSMB) has endorsed the continuation of Cassava Sciences' Phase 3 trials for simufilam in Alzheimer's disease.
  • The DSMB's recommendation is based on an interim safety review, with no modifications suggested for the ongoing clinical trials.
  • Top-line results from the first Phase 3 trial, involving 804 patients over 52 weeks, are anticipated by the end of 2024.
  • Simufilam, a small molecule drug, targets filamin A and has shown no association with treatment-emergent ARIA in interim MRI data.

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT05026177TerminatedPhase 3
Cassava Sciences, Inc.
Posted 11/18/2021

Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT04994483CompletedPhase 3
Cassava Sciences, Inc.
Posted 11/3/2021

Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients

NCT04388254CompletedPhase 2
Cassava Sciences, Inc.
Posted 3/24/2020

Psychedelic Therapies Approach Europe Amidst Regulatory and Access Challenges

  • Psychedelic therapies, including psilocybin and MDMA, are gaining traction in Europe for treating mental health conditions like depression and addiction.
  • Clinical trials are underway across Europe, with Compass Pathways leading the way in testing psilocybin for treatment-resistant depression.
  • Regulatory hurdles, highlighted by the FDA's rejection of MDMA-assisted therapy for PTSD in the US, pose challenges to European approval processes.
  • Experts emphasize the need for rigorous clinical trials and strategies to ensure patient access and integration into standard healthcare practices.

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