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Clinical Trial News

Placental Evaluation Enhances Risk Assessment for Retinopathy of Prematurity

  • A recent study identifies maternal and fetal vascular malperfusion as significant factors in retinopathy of prematurity (ROP) risk, enhancing current screening methods.
  • Maternal vascular malperfusion correlates with higher gestational age and lower birthweight, while fetal malperfusion is associated with lower birthweight and reduced mechanical ventilation duration.
  • Placental factors like distal villous hypoplasia, severe acute histologic chorioamnionitis, and funisitis are independently linked to ROP, offering new targets for early identification.
  • Evaluating placental risk factors shortly after birth may enable earlier identification of high-risk infants and personalized interventions to prevent ROP development.

Talquetamab and Teclistamab Combination Shows Promising Results in Relapsed/Refractory Multiple Myeloma

  • Updated results from the Phase 1b RedirecTT-1 study show the combination of talquetamab and teclistamab yields high response rates in relapsed/refractory multiple myeloma patients.
  • The bispecific antibody combination demonstrates durable responses and a manageable safety profile, consistent with each agent's monotherapy profile.
  • Patients with extramedullary disease, often resistant to standard therapies, also showed meaningful overall response rates and duration of response with the combination.
  • The findings support further investigation of talquetamab-based combinations in multiple myeloma treatment, especially for those with limited options.
NCT05972135RecruitingPhase 2
SCRI Development Innovations, LLC
Posted 10/23/2023
NCT06500884RecruitingPhase 2
Janssen Research & Development, LLC
Posted 8/26/2024
NCT04722146Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 3/12/2021
NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020
NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017
NCT05050097Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/22/2021

PfSPZ Vaccine Demonstrates Efficacy Against Malaria in Women Anticipating Pregnancy

  • The PfSPZ vaccine showed significant efficacy against P. falciparum parasitemia in women anticipating pregnancy, offering a potential preconception immunization strategy.
  • In phase 2 trials, both doses of the PfSPZ vaccine demonstrated efficacy against parasitemia and clinical malaria at years 1 and 2 in women of childbearing age.
  • The vaccine was well-tolerated, with mild adverse events, and serious adverse events occurring at similar rates across study groups, including the placebo group.
  • Vaccine efficacy against post-conception P. falciparum parasitemia during first pregnancies was approximately 57% and 49% in the two dosage groups, respectively.

IDEAYA's Darovasertib Shows Promise in Neoadjuvant Uveal Melanoma Phase 2 Trial

  • IDEAYA Biosciences reports interim Phase 2 data for darovasertib in neoadjuvant uveal melanoma (UM).
  • The FDA provided guidance on a registrational trial design based on a Type C meeting.
  • Darovasertib is a selective protein kinase C (PKC) inhibitor targeting primary and metastatic UM.
  • An investor webcast will present the Phase 2 clinical data and regulatory update.

BWC0977: A Novel Antibacterial Agent Shows Promise Against Multi-Drug Resistant Infections

  • BWC0977, a novel bacterial topoisomerase inhibitor, has demonstrated efficacy against multi-drug resistant pathogens, including strains resistant to fluoroquinolones and carbapenems.
  • The drug's unique mechanism of action targets a broad spectrum of bacteria, encompassing both Gram-positive and Gram-negative types, distinguishing it from traditional antibiotics.
  • Clinical trials have shown BWC0977 to be safe and well-tolerated in healthy volunteers, with ongoing development including an oral formulation to enhance patient accessibility.

University of Hong Kong to Enhance AI Tool for Cardiovascular Disease Risk Prediction

  • The University of Hong Kong (HKU) is launching a recruitment round for its "Heartwise" study, aiming to enroll 3,000 patients.
  • The study seeks to improve the accuracy of the "P-Cardiac" tool, an AI-powered system for predicting cardiovascular disease risk.
  • "P-Cardiac" utilizes Asia's largest patient records database, encompassing 300,000 records from the Hospital Authority.
  • Researchers hope the improved tool will enhance cardiovascular disease risk assessment and personalize healthcare strategies.

Molecular Imaging Reveals Mechanism Behind BCG Resistance in Bladder Cancer, Leading to New Trial

  • A recent imaging study has elucidated the mechanisms behind BCG resistance in non-muscle invasive bladder cancer (NMIBC) by assessing gene and protein activity in tumor samples.
  • The study identified the upregulation of the immune checkpoint NKG2A in immune cells, suggesting a potential target for overcoming BCG resistance.
  • Findings from this research have directly led to the launch of the phase 2 ENHANCE trial (NCT06503614), which will test the combination of durvalumab and monalizumab.
  • The ENHANCE trial will enroll patients with BCG-unresponsive NMIBC, including carcinoma in situ and papillary tumors, with the goal of improving treatment outcomes.

FDA Approves Shield Blood Test for Colorectal Cancer Screening

  • The FDA has approved Shield, the first blood test for primary colorectal cancer screening, offering a less invasive option for average-risk adults.
  • Shield demonstrated high sensitivity in detecting existing colorectal cancers (83%) but lower sensitivity (13%) for precancerous polyps in a study of nearly 8,000 participants.
  • Experts emphasize the importance of follow-up colonoscopies after positive Shield test results to remove precancerous growths and prevent cancer deaths.
  • While Shield could increase screening rates, questions remain about its cost-effectiveness and long-term impact on reducing colorectal cancer incidence and mortality.

Whooping Cough Cases Surge in the U.S., Prompting Review of Vaccine Testing Methods

  • Pertussis cases in the U.S. have increased fivefold compared to last year, reaching the highest levels since 2014, indicating a return to pre-pandemic infection rates.
  • Current pertussis vaccines offer strong initial protection, but their effectiveness wanes after two to three years, contributing to the upward trend in infections despite high vaccination rates.
  • The FDA is considering the use of human challenge trials, where participants are intentionally infected, to accelerate the development and testing of more effective pertussis vaccines.
  • Experts are exploring if challenge trials can accurately measure vaccine efficacy, while acknowledging the need to refine these models to ensure they provide sufficient evidence for vaccine approval.

Moderna's mRNA Cancer Vaccine Shows Promising Early Results in Solid Tumors

  • Moderna's mRNA vaccine demonstrates encouraging early results in a trial targeting advanced solid cancers, enhancing the immune system's ability to recognize and kill cancerous cells.
  • The vaccine represents a personalized approach, potentially offering an 'off-the-shelf' solution for various cancer types based on individual tumor profiles.
  • Early trial data suggests the vaccine's capability to stimulate immune responses against cancer cells, marking a significant step forward in cancer immunotherapy.
  • This development highlights the potential of mRNA technology beyond infectious diseases, paving the way for innovative cancer treatments.
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