Flexbumin (albumin (human) solution) / Takeda - LARVOL DELTA

Phase I Study Evaluating Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Recombinant Human Serum Albumin (rHSA) in Healthy Adults. (PubMed, Drug Des Devel Ther) - "Based on these outcomes, Part 2 (n=50) was conducted as a randomized (1:1), active-controlled, parallel-group study comparing rHSA with pdHSA (Flexbumin® 20%) administered at escalating doses (10 g, 20 g, and 40 g) with 3-week intervals...Low-titre IgG antibodies were detected in a few participants, without clinical relevance, with no IgE or anti-host cell protein (HCP) antibodies detected. The test rHSA was well tolerated at cumulative doses of 70 g and demonstrated comparable PK, PD, safety and immunogenicity profiles to pdHSA, supporting its potential as a viable alternative."

Clinical • Journal • P1 data • PK/PD data

[VIRTUAL] Human IPSC-Derived Committed Cardiac Progenitor Cells Engraft and Differentiate Following Transendocardial Injections in a Swine Ischemic Heart Failure Model (AHA 2021) - "28 days later, TEI targeting the peri-infarct region was performed using combinations of 200 million CCPs with or without 50 mg CFM particles and Flexbumin control... TEI of CCPs, with and without CFM, resulted in grafts of human cardiomyocytes in the myocardium of immunosuppressed pigs, after 1 month post MI. Ongoing cardiac MRI analyses will determine the impact of CCP therapy on cardiac structure and function."

Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Oncology • Ventricular Tachycardia • MRI

"Takeda Receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia https://t.co/RjFiFGap89" (,@NewsFromBW)

FDA event