Ligand Pharma (LGND) Reports Melphalan Met All Endpoints in Phase II Study

Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reports data from the Phase II study with its Captisol-enabled, propylene glycol-free (PG-free) melphalan.

This Phase II study compared the safety, tolerability and pharmacokinetic profiles of a new PG-free melphalan intravenous formulation and the current clinically used intravenous formulation of melphalan (sold as Alkeran®) for multiple myeloma patients undergoing autologous transplantation. This Captisol-enabled product is expected to allow for longer administration durations and slower infusion rates, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy.

Trial Highlights and Primary Features of PG-free Melphalan:

• The Phase II trial successfully met all endpoints, and PK analysis revealed that the new PG-free melphalan met the requirements for establishment of bioequivalence to Alkeran
  
  
• Based on these Phase II results, the follow-on pivotal study will utilize a dosing regimen comparable to Alkeran. The pivotal study will be designed to expose patients exclusively to the PG-free formulation and will further elaborate safety and efficacy measures for the product
  
  
• Captisol-enabled, PG-free melphalan is presented in a simple single-vial system and will provide dosing flexibility as compared to the current two-vial PG format for Alkeran
  
  
• Alkeran currently must be used within one hour after formulation. The new PG-free formulation is potentially more stable offering alternate dosing options to clinicians
  
  
• Removal of PG significantly changes the potential side-effect profile of melphalan

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