About Captisol-enabled MelphalanLigand's Captisol-enabled, PG-free melphalan program is a new intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, and has been granted Orphan designation by the FDA. Ligand's formulation avoids the use of propylene glycol, which has been reported to cause renal and cardiac side-effects that limit the ability to deliver higher quantities of therapeutic compounds. The use of the Captisol ® technology to reformulate melphalan is anticipated to allow for longer administration durations and slower infusion rates, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy. In December 2012 Ligand announced the initiation of a pivotal trial of Captisol-enabled melphalan. 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 Captisol-enabled melphalan 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).
Ligand Signs Global License Agreement With Spectrum Pharmaceuticals For Captisol-Enabled® Melphalan
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