Ligand Pharmaceuticals Incorporated (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.
"The initiation of the pivotal trial for our Captisol-enabled, PG-free melphalan is an important development for this program, and for Ligand," commented Matthew W. Foehr, Chief Operating Officer of Ligand Pharmaceuticals. "This proprietary product has Orphan Drug designation and a compelling therapeutic profile. While this pivotal trial is underway, we will be evaluating options to license this valuable asset to a strategic partner or commercialize it on our own."
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