Ligand Pharmaceuticals' Captisol-enabled, propylene glycol-free drug melphalan has met all the endpoints in a Phase II trial treating patients with multiple myeloma.
Developed by Higuchi Biosciences Center, Captisol is a patent-protected, chemically altered cyclodextrin.
The Phase II study compared the safety, tolerability and pharmacokinetic profiles of an intravenous formulation of propylene glycol-free melphalan to the standard multiple myeloma treatment.
The Captisol-enabled drug will provide longer administration durations and slower infusion rates, enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy.
The trial, conducted in partnership with The University of Kansas Cancer Center, is partially funded by the Kansas Bioscience Authority.
The company plans to begin the 60-patient pivotal trial to further evaluate the safety and efficacy of the drug candidate in 2012.