Ligand Pharma Begins Pivotal Trial of Captisol-Enabled Propylene Glycol-Free Melphalan for Multiple Myeloma Patients
Ligand Pharma (NASDAQ: LGND) announced today that it has initiated a pivotal trial of Captisol-enabled^®, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma. This multi-center trial will evaluate safety and efficacy in 60 patients, and is intended to confirm the results from an earlier Phase 2 study demonstrating that the PG-free melphalan intravenous formulation was safe and well-tolerated, and met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan (sold by GlaxoSmithKline as Alkeran^® for Injection).
Given the robust dataset compiled to date along with the pivotal study design, Ligand believes that should this pivotal trial produce positive results, the Company will be in a position to submit a 505(b)(2) New Drug Application to the U.S. Food and Drug Administration.
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