Clinical Trial News

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Robin Dobbins, an oncology research nurse at Georgia Cancer Center, manages pediatric immunotherapy trials, supporting kids with relapsed brain tumors. Despite initial reluctance, she finds fulfillment in her role, connecting with families and contributing to ALSF-funded research, aiming for a Phase 3 trial.

Healthy adults with BMI < 45 kg/m2, no diabetes, heart, or kidney issues can participate. Study includes meals, treadmill exercise, glucose test, blood/urine samples, and genetic info collection. $300 compensation. Meals provided. Contact: genesis@uabmc.edu or (205) 975-3956.

Lundbeck starts phase I study with second-generation migraine drug Lu AG09222 for potential combination treatment in migraine prevention, as per Clinical Trials registration.

Robin Love's participation in a clinical trial at The University of Kansas Cancer Center 18 years ago led to significant advancements in breast cancer treatment. Dr. Carol Fabian highlights the progress in understanding breast cancer as multiple diseases, with 70-80% responding well to treatment. Love's HER2-positive breast cancer, once aggressive, is now survivable, inspiring her son to become a doctor. Fabian emphasizes the importance of clinical trials and precision medicine in improving survivorship and early detection.

FDA reviewers express concerns over the benefits vs. risks of sulopenem etzadroxil/probenecid, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs), ahead of an advisory committee meeting. The drug, with activity against gram-positive, gram-negative, and anaerobic organisms, was rejected in 2021 but resubmitted by Iterum Therapeutics in April after another phase III trial. The new trial data showed non-inferiority to amoxicillin/clavulanate but had a small sample size of resistant organisms, raising efficacy questions. The FDA warns of potential inappropriate use and antimicrobial resistance (AMR) risks, emphasizing the need for careful stewardship and guideline considerations.

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

Elutia Inc. celebrates one-year anniversary with FDA approval for EluPro™, 20% sales growth, and 170% shareholder value increase.

Relay Therapeutics to report interim data for RLY-2608 600mg BID + fulvestrant in 2L+, CDK4/6-experienced patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer on Sept. 9, 2024, at 8am ET.

GSK announced positive results from the MATINEE phase III trial, showing Nucala (mepolizumab) significantly reduced COPD exacerbations. Nucala targets IL-5 in type 2 inflammation, with consistent safety results. Full data will be presented at a future scientific congress.