CyDex set to launch CDX-353 trial for Rx of multiple myeloma

The FDA has accepted an Investigational New Drug (IND) application from CyDex Pharmaceuticals for a clinical study of Captisol-enabled melphalan HCL (CDX-353). Melphalan (Alkeran) is an FDA-approved low-dose chemotherapy for multiple myeloma marketed by GlaxoSmithKline. A phase II(a) trial that compares the pharmacokinetics and safety of CDX-353 with Alkeran is planned. Alkeran is packaged as two vials that must be combined prior to injection and requires immediate administration. CDX-353 is a one-vial formulation that remains stable at room temperature for an extended period of time, according to CyDex.