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Ligand Pharma
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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