( MENAFN - PR Newswire) HEIDELBERG, Germany , May 29, 2024 /PRNewswire/ -- Full-Life Technologies (Full-Life), a fully integrated global radiotherapeutics company, today announced it has received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) for clinical trials of 225Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The company plans to begin clinical studies in the U.S. and globally in 2024.
225Ac-FL-020 employs targeted alpha-radiotherapy designed to selectively attack cancer cells, reducing the damage to healthy tissues. In preclinical models, radiolabeled FL-020 displayed a very promising in vivo biodistribution profile, with high and sustained tumor uptake and fast systemic clearance. 225Ac-FL-020 exhibited robust anti-tumor activity in LNCaP xenograft mice, with a favorable safety profile.
The upcoming Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020, and will lay the groundwork for further clinical development, aiming to establish 225Ac-FL-020 as a valuable therapeutic option for patients with mCRPC. "The IND application clearance is a significant regulatory milestone in our development plan for 225Ac-FL-020", said Steffen Heeger, M.D.
, M.Sc., Chief Medical Officer of Full-Life.
"This important step underscores our overall commitment to the therapeutic potential of radiopharmace.
