Benefit of Avasopasem Manganese on Severe Oral Mucositis in Head and Neck Cancer in the ROMAN Trial: Unplanned Secondary Analysis.

Purpose: Oral mucositis (OM) is a debilitating side effect of cisplatin and intensity-modulated radiation therapy (IMRT) in patients with head and neck cancer. The phase 3 ROMAN trial showed avasopasem manganese (AVA) significantly decreased individual endpoints of incidence and duration of severe oral mucositis (SOM, World Health Organization [WHO] grade 3-4), with nominal decrease in severity (WHO grade 4) and significant increase in the delay in onset of SOM. We sought to determine the Net Treatment Benefit (NTB) of AVA versus placebo (PBO) using the generalized pairwise comparisons (GPC) method.

Subclinical malaria among pregnant women living in refugee settlements in Northern Uganda.

Background: Malaria during pregnancy contributes to significant perinatal morbidity and mortality, accounting for almost 25% of global maternal mortality. However, the epidemiology and risk factors for subclinical malaria among pregnant women living in refugee settlements is poorly understood.

Objective: To determine the prevalence and predictors of subclinical malaria among pregnant women in refugee settlements in Northern Uganda.

Child feces disposal practices in humanitarian and non-humanitarian settings across 34 low- and middle-income countries.

Globally, safe sanitation has improved significantly in the last two decades, but unsafe child feces disposal remains a growing challenge in many regions, exposing household members and communities to infectious pathogens. The drivers associated with child feces disposal in several contexts including humanitarian settings are not well understood. This study investigated child feces disposal (CFD) practices and associated factors in low- and middle-income countries, including in humanitarian settings.

Superoxide Dismutase Mimetic Avasopasem Manganese Enhances Radiation Therapy Effectiveness in Soft Tissue Sarcomas and Accelerates Wound Healing.

Soft tissue sarcomas (STSs) are mesenchymal malignant lesions that develop in soft tissues. Despite current treatments, including radiation therapy (RT) and surgery, STSs can be associated with poor patient outcomes and metastatic recurrences. Neoadjuvant radiation therapy (nRT), while effective, is often accompanied by severe postoperative wound healing complications due to damage to the surrounding normal tissues.

Patient-centric Comparability Assessment of Biopharmaceuticals.

The comparability assessment of a biological product after implementing a manufacturing process change should involve a risk-based approach. Process changes may occur at any stage of the product lifecycle: early development, clinical manufacture for pivotal trials, or post-approval. The risk of the change to impact product quality varies.