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Clinical Trial News

Epitomee Medical Receives FDA Approval for Weight Management Pill

  • Epitomee Medical's weight management pill has received FDA approval for sale in the US, causing a significant surge in the company's share price.
  • The pill works by expanding in the stomach to create a feeling of fullness, targeting individuals with mild to moderate obesity.
  • Clinical trial data showed that 27% of patients lost at least 10% of their body weight using Epitomee's pill.
  • Epitomee plans to partner with distributors in the US and Europe, with a product launch anticipated in the third quarter of 2025.

Durvalumab Plus Chemotherapy Improves Outcomes in Muscle-Invasive Bladder Cancer

  • The NIAGARA phase 3 trial demonstrated that perioperative durvalumab combined with neoadjuvant chemotherapy significantly improved event-free survival in cisplatin-eligible MIBC patients.
  • Overall survival was also significantly improved with the addition of durvalumab, showing a 25% reduction in the risk of death compared to chemotherapy alone.
  • The combination of durvalumab and chemotherapy did not result in a significant increase in grade 3 or 4 adverse events compared to chemotherapy alone, suggesting a manageable safety profile.
  • These findings support perioperative durvalumab with neoadjuvant chemotherapy as a potential new standard of care for cisplatin-eligible muscle-invasive bladder cancer.

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NCT03732677Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/16/2018

FDA Approves First Over-the-Counter Hearing Aid Software for Apple AirPods

  • The FDA has approved the first over-the-counter (OTC) hearing aid software, designed for use with widely available consumer audio products like Apple's AirPods.
  • This authorization aims to increase the accessibility and affordability of hearing support for adults experiencing perceived mild to moderate hearing loss.
  • Apple's AirPods Pro will feature Hearing Test and Hearing Aid capabilities, potentially benefiting over a billion people affected by hearing loss worldwide.
  • The FDA also issued warning letters to two Chinese nonclinical testing laboratories, citing concerns over data quality, integrity, and animal care violations.

In Vivo CAR T-Cell Therapies Advance to Clinical Trials, Promising Faster, Cheaper Cancer Treatment

  • In vivo CAR T-cell generation uses off-the-shelf reprogramming cassettes, potentially reducing manufacturing time and costs compared to ex vivo CAR Ts.
  • Clinical trials are underway to assess the safety and efficacy of in vivo CAR T-cell therapies in treating blood cancers and autoimmune diseases.
  • Lentiviral vectors and lipid nanoparticles (LNPs) are being explored as delivery vehicles for CAR payloads, each with unique advantages and challenges.
  • Researchers are expanding the application of in vivo CAR T-cell therapies beyond T cells to target myeloid cells for solid tumor treatment.

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

NCT03744676CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/29/2018

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123CompletedPhase 1
Jazz Pharmaceuticals
Posted 9/30/2016

Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma

NCT04257578Active, Not RecruitingPhase 1
University of Washington
Posted 12/2/2020

CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML

NCT02944162Unknown StatusPhase 1
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Posted 10/1/2016

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

NCT04484012RecruitingPhase 2
City of Hope Medical Center
Posted 12/31/2020

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018

Certa Therapeutics' GPR68 Inhibitor FT011 Receives International Non-Proprietary Name: Asengeprast

  • Certa Therapeutics' lead drug candidate FT011 has been granted the International Non-Proprietary Name (INN) 'asengeprast' by the World Health Organization.
  • Asengeprast is a first-in-class oral GPR68 antagonist being developed for treating chronic fibrosis in multiple organs, demonstrating efficacy in preclinical models.
  • Clinical studies have shown favorable efficacy, safety, and pharmacokinetics of asengeprast in systemic sclerosis (SSc) patients, with plans for a Phase IIb trial.
  • Certa Therapeutics is also developing biomarkers and gene signatures to identify patients most likely to respond to asengeprast treatment.

PatientSeek Identifies Genetic Signature for Vedolizumab Response in Ulcerative Colitis

  • C4X Discovery's PatientSeek platform has identified a genetic signature that distinguishes responders from non-responders to vedolizumab in ulcerative colitis patients.
  • The genetic signature is based on variations in non-coding regions of DNA and offers a stable, time-independent biomarker for patient selection.
  • This precision medicine approach could lead to smaller, more efficient clinical trials by targeting the right patients for a4b7 integrin therapies.
  • The discovery marks a significant advancement in immuno-inflammation precision medicine, potentially guiding clinical practice for IBD treatment.

AstraZeneca's Imfinzi Shows Promise in Extending Lives of Bladder Cancer Patients

  • AstraZeneca's Imfinzi, combined with standard care, significantly reduced the risk of disease recurrence by 32% in muscle-invasive bladder cancer patients.
  • The late-stage trial involving 1,063 patients demonstrated that Imfinzi also lowered the risk of death by 25% when used with treatments like chemotherapy.
  • Positive data from the Imfinzi trial has boosted AstraZeneca's shares, potentially increasing annual revenue by $500 million if approved for this new patient group.
  • The study's findings, presented at the European Society for Medical Oncology Congress, mark the first instance of an immunotherapy drug improving survival in this cancer type.

FDA Approves Dupixent as First Treatment for CRSwNP in Adolescents

• The FDA has approved Dupixent (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). • This marks the first approved treatment option for CRSwNP in this younger age group, addressing a significant unmet need in upper airway inflammatory diseases. • The approval was based on data from adult trials (SINUS-24 and SINUS-52) and pharmacokinetic data from adolescent asthma studies, demonstrating efficacy and safety. • Dupixent, a monoclonal antibody targeting interleukin-4 and interleukin-13, has now been approved in over 60 countries for various type 2 inflammation-related diseases.

MEDSIR Presents Promising Results in Breast and Thymic Cancer Trials at ESMO

• The ABIGAIL study showed that abemaciclib with endocrine therapy achieved a 59% overall response rate at 12 weeks in HR+/HER2- advanced breast cancer, versus 40% with chemotherapy. • The PECATI study demonstrated an 88% progression-free rate at 5 months using lenvatinib and pembrolizumab in advanced thymic tumors, offering a potential new standard of care. • MEDSIR also hosted MEDTalks, focusing on advancing research in brain metastasis, a critical unmet need in solid tumors like lung, breast, and skin cancers.

Deep Learning Identifies Behavioral Risk Profiles for Ventricular Arrhythmias

  • A new study uses deep learning to analyze physical behavior data from wearable accelerometers to predict the risk of malignant ventricular arrhythmias.
  • The study identified distinct behavioral profiles associated with varying risks of ICD therapy and death in patients with ICDs.
  • Findings suggest that behavioral patterns, captured through wearable technology and analyzed with AI, can improve risk stratification for ventricular arrhythmias.
  • This approach offers a novel way to personalize management strategies for patients at risk of life-threatening arrhythmias.

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