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Atypical Antipsychotics in Dementia: Balancing Benefits and Risks in BPSD Management

  • Behavioral and Psychological Symptoms of Dementia (BPSD) affect nearly all dementia patients, increasing hospitalization, neglect, and mortality risks.
  • Atypical antipsychotics (AAPs) have historically been used off-label for BPSD, but carry risks of cerebrovascular events and increased mortality in older patients.
  • The DICE approach (Describe, Investigate, Create, Evaluate) prioritizes non-pharmacologic interventions, reserving AAPs for severe cases posing imminent harm.
  • Brexpiprazole is the first AAP with FDA approval for agitation in Alzheimer's dementia, showing improved safety and efficacy in clinical trials.

Belzutifan Shows Sustained Efficacy in VHL-Associated CNS Hemangioblastomas

  • Belzutifan demonstrates meaningful antitumor activity in von Hippel-Lindau (VHL) disease-associated central nervous system (CNS) hemangioblastomas, with efficacy sustained over three years.
  • In a Phase II trial, 44% of patients with VHL-associated CNS hemangioblastomas achieved an objective response with belzutifan, and 46% experienced stable disease.
  • The median duration of response to belzutifan was not reached, indicating a prolonged benefit for patients with VHL-related CNS tumors.
  • Belzutifan's safety profile showed manageable adverse events, supporting its role as a systemic treatment option for VHL disease-related CNS hemangioblastomas.

Bladder Preservation Therapy Gains Ground as Viable Alternative to Cystectomy for Muscle-Invasive Bladder Cancer

  • Trimodality therapy (TMT), combining maximal TURBT and chemoradiation, is increasingly recognized as a primary treatment option for muscle-invasive bladder cancer (MIBC).
  • Studies show TMT yields comparable long-term clinical outcomes to radical cystectomy, with similar safety and tolerability, particularly with modern radiation techniques.
  • Ongoing trials, like SWOG/NRG 1806 (INTACT), explore TMT's combination with immunotherapy, while others investigate the role of neoadjuvant chemotherapy.
  • Research suggests TMT may expand to non-muscle invasive and metastatic bladder cancer, offering bladder-preserving options and improved survival in select patients.

NRx Pharmaceuticals' NRX-100 (Ketamine) Achieves Stability Milestone, NDA Filing on Track

  • NRx Pharmaceuticals' NRX-100 (Ketamine) demonstrated twelve-month real-time stability, a crucial step toward FDA approval for treating suicidal depression.
  • The stability data supports a projected room temperature shelf life exceeding three years, facilitating the drug's potential commercial viability.
  • NRX-100 is formulated as a preservative-free, single-dose vial, which could mitigate toxic side effects associated with traditional ketamine formulations.
  • The company plans to submit a New Drug Application (NDA) to the FDA in 2024, potentially offering a new treatment option for individuals at risk of suicide.

SABR Shows Promise in Renal Cell Carcinoma Management

• Stereotactic ablative radiotherapy (SABR) is emerging as a valuable strategy for managing renal cell carcinoma (RCC), particularly in oligometastatic and oligoprogressive settings. • Studies indicate SABR can delay the need for systemic therapy in oligometastatic RCC, offering a less toxic and more cost-effective alternative to doublet immunotherapy regimens. • Research suggests SABR can extend the efficacy of existing systemic treatments in oligoprogressive RCC, potentially deferring the need for escalation to later-line therapies. • Ongoing trials are investigating SABR's role in treating primary RCC lesions and variant histologies, highlighting its versatility in advanced RCC management.

SBRT with Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

NCT04090710Active, Not RecruitingPhase 2
Ontario Clinical Oncology Group (OCOG)
Posted 1/29/2020

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

NCT05327686RecruitingPhase 2
NRG Oncology
Posted 2/1/2023

H. pylori Screening with FIT Does Not Significantly Reduce Gastric Cancer Rates in Taiwan Trial

  • A large randomized trial in Taiwan found that adding a Helicobacter pylori stool antigen test (HPSA) to fecal immunochemical testing (FIT) did not significantly reduce gastric cancer incidence or mortality.
  • Screening participation was higher in the HPSA+FIT group (49.6%) compared to the FIT-alone group (35.7%), potentially influencing the overall results of the study.
  • Post-hoc analyses, adjusting for screening participation and follow-up, suggested a potential reduction in gastric cancer incidence with HPSA+FIT, but no significant impact on mortality.
  • The study highlights the complexities of implementing H. pylori screening programs and the need for further research to optimize screening strategies for gastric cancer prevention.

Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing

NCT01741363CompletedNot Applicable
National Taiwan University Hospital
Posted 1/1/2014

Lanifibranor Shows Promise in Phase 3 MASH Trial with Improved Liver Health Biomarkers

• Interim analysis of the Phase 3 NATiV3 trial reveals that lanifibranor shows potential in improving liver health in patients with metabolic-associated steatohepatitis (MASH). • The global study, involving 837 participants, assesses lanifibranor's impact on MASH resolution and fibrosis reduction over 72 weeks, with top-line results expected by late 2026. • Lanifibranor, an oral PPAR agonist, demonstrated improvements in liver function, reduced fibrosis, and better blood fat and glucose levels in the blinded analysis of pooled data. • The ongoing NATiV3 trial includes patients on GLP-1 receptor agonists, potentially providing insights into the benefits of combining these medications with lanifibranor.

Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

NCT05232071CompletedPhase 2
Inventiva Pharma
Posted 6/29/2022

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

NCT04849728RecruitingPhase 3
Inventiva Pharma
Posted 8/19/2021

Phase 2b Study in NASH to Assess IVA337

NCT03008070CompletedPhase 2
Inventiva Pharma
Posted 2/7/2017

U.P. Oncolytics Receives NIH Grant to Advance Oncolytic Zika Virus Therapy for Glioblastoma

  • U.P. Oncolytics has been awarded a $500,000 NIH fast-track grant to support the development of a novel oncolytic Zika virus therapy for glioblastoma.
  • The grant will fund critical in vitro and in vivo studies to validate the therapeutic approach and advance it towards an FDA Investigational New Drug application.
  • Glioblastoma remains a highly lethal brain cancer with limited treatment options, highlighting the urgent need for innovative therapies like U.P. Oncolytics' approach.
  • Preclinical data suggests that the oncolytic Zika virus can overcome glioblastoma's resistance mechanisms, offering a potential breakthrough in treatment.

CureLGMD2i and myTomorrows Partner to Enhance Clinical Trial Access for Limb-Girdle Muscular Dystrophy Patients

• CureLGMD2i Foundation and myTomorrows have partnered to improve access to clinical trials for Limb-Girdle Muscular Dystrophy (LGMD) patients, caregivers, and healthcare professionals. • The partnership leverages myTomorrows’ search engine to provide up-to-date information on pre-approval treatments and support for patients engaging with these treatments. • Challenges in LGMD clinical trials include the rarity of subtypes, patient access to trial sites, and the need for increased awareness and accurate subtyping for effective treatment. • Current LGMD research includes a Phase 3 trial for a small molecule drug and Phase 2 trials for gene therapies, offering hope but also raising questions about eligibility and long-term effects.

Siemens Healthineers' Mammomat B.brilliant Receives FDA Approval for 3D Mammography

• Siemens Healthineers' Mammomat B.brilliant has received FDA premarket approval for its tomosynthesis, enhancing breast imaging capabilities. • The system features PlatinumTomo technology, enabling rapid 3D image acquisition and reducing blur for more confident diagnoses. • The device includes features to improve workflow for technologists and enhance patient comfort during breast cancer screening. • UltraHD image reconstruction technology minimizes metal artifacts and offers customizable image settings, improving visualization.

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