2 February 2012 - Ligand Pharmaceuticals Inc (NASDAQ:LGND) unveiled positive results of its Phase II trial of Captisol-enabled, propylene glycol-free (PG-free) Melphalan programme.

The Phase II study was designed to compare the safety, tolerability and pharmacokinetic profiles of the PG-free Melphalan intravenous formulation and the current clinically-used intravenous formulation of Melphalan for multiple myeloma patients undergoing autologous transplantation.

The Phase II study successfully met all endpoints, with the new PG-free Melphalan showing to be bioequivalent to Alkeran per guidance requirements, while also demonstrating a marginally higher systemic drug exposure (112%).

Results showed that PG-free Melphalan, administered as half of a high-dose conditioning regimen, resulted in successful myeloablation (100% of patients) and subsequent engraftment (100% of patients) with no additional toxicity.

The positive results of the Phase II study will allow the follow-on pivotal study to use a dosing regimen comparable to Alkeran. The pivotal study will expose patients exclusively to the PG-free Melphalan formulation and will further assess its safety and efficacy.