Clinical Trial News

Shan Lu, MD, PhD, co-authored studies on a Phase I HIV vaccine trial showing strong immune responses, including 100% CD4+ T cell responses. A separate study identified a novel human monoclonal antibody, HmAb64, neutralizing various HIV subtypes, marking significant progress in HIV vaccine development.

Vitamin D treatment reduced BPPV recurrence by 87% in a double-blind RCT, with 0.75 fewer episodes per person-year vs. placebo. Longer time to first recurrence in treatment group. Future studies needed to explore vitamin D as standard care for BPPV.

Guard Therapeutics has announced the dosing of the first patient in its phase 2b clinical study, POINTER, evaluating RMC-035 as a kidney-protective treatment during open-heart surgery. The study, starting in Canada and expanding to Europe, aims to determine the optimal dosing regimen and target population for RMC-035.

QLIFE HOLDING AB faced financial and legal challenges in Q2 2024, including a significant net loss and arbitration loss against Aidian Oy, leading to bankruptcy filing for its Danish subsidiary. Despite these, operational progress was noted, including CRP biomarker trials in China and participation in a PKU research trial in the USA. The company aims to restructure and focus on the home-hospital segment and rare diseases.

An observational study in The BMJ suggests diabetes drugs, specifically SGLT-2 inhibitors, may lower dementia risk. Experts emphasize the need for controlled trials to confirm these findings and understand the mechanisms behind the potential protective effects on the brain.

The PAIN trial at University of Utah Health aims to compare fentanyl and ketamine for prehospital pain management in injured patients, aiming to enhance patient comfort and outcomes while reducing risks associated with opioids.

The study analyzed CheckMate 141 trial data to estimate cure proportions in patients treated with nivolumab for recurrent squamous cell carcinoma of the head and neck, using a Flexible Parametric Cure Model (FPCM) with varying knot numbers and placements. The FPCM, compared to the Kaplan-Meier (KM) method and Weibull Non-Mixture Cure Model (WNCM), showed significant impact of knot placement on cure proportion estimates. A simulation study was conducted to determine optimal knot placement for accurate cure proportion estimation.

GATC Health Corp. partners with Medical and Commercial International Limited to develop an AI-based financing model for clinical trials, approved by Lloyd's of London, aiming to provide insurance coverage for funding in case of trial failure, using AI technology to predict efficacy and safety of pharmaceutical assets.

Clearside Biomedical completes final participant visit in phase 2b ODYSSEY trial of CLS-AX for wet AMD, aiming to provide a safer treatment option with reduced burden. Topline results expected in early October.

YolTech Therapeutics dosed first two patients in YOLT-203 trial, an in vivo gene-editing therapy for primary hyperoxaluria type 1 (PH1), targeting AGXT gene mutations to reduce oxalate levels.