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- The subcutaneous formulation of daratumumab with hyaluronidase-fihj (Darzalex Faspro) allows multiple myeloma patients to complete treatment visits in under one hour compared to 3-4 hours with intravenous administration. - After the first treatment cycle, patients receiving subcutaneous daratumumab can forgo premedication and observation requirements that are necessary with each intravenous infusion cycle. - The subcutaneous formulation maintains a similar adverse event profile to intravenous daratumumab while providing improved convenience through a 15 ml injection administered slowly in the abdomen. - Healthcare providers emphasize that the subcutaneous option has become the preferred formulary choice due to reduced chair time and improved patient experience without compromising safety or efficacy.
- Kane Biotech has received IRB approval from the University of Miami Health System to commence a clinical study of its DispersinB® Acne Cleanser for mild to moderate Acne Vulgaris. - The split-face efficacy trial will enroll up to 24 subjects at the University of Miami Miller School of Medicine, with the study expected to begin by mid-2025. - DispersinB® represents a novel biofilm-targeting approach to acne treatment, leveraging Kane Biotech's expertise in microbial biofilm prevention and removal technologies.
- AION Healthspan has initiated a Phase I/II clinical trial for REJUVXL, a novel cell therapy targeting inflammation, fibrosis, and immune dysregulation in Stage 3 Chronic Kidney Disease patients. - The groundbreaking therapy, administered through IV infusion, aims to potentially slow or reverse CKD progression without requiring immunosuppressive drugs, addressing a condition affecting 110 million people in the US and Europe. - The trial, being conducted at the University of Miami Health System, could transform CKD treatment by targeting underlying disease mechanisms rather than just managing symptoms like current therapies.
- A phase 1b trial combining luspatercept and lenalidomide demonstrates safety and preliminary efficacy in patients with non-del(5q) myelodysplastic syndrome (MDS). - The combination therapy showed a 50% hematologic improvement rate among evaluable patients, with notable red blood cell transfusion independence. - The study established a recommended phase 2 dose (RP2D) of lenalidomide at 10 mg daily and luspatercept at 1.0 mg/kg every 21 days. - These findings support further investigation of this combination to improve outcomes for lower-risk MDS patients lacking the del(5q) abnormality.
