FDA has accepted CyDex’s Investigational New Drug (IND) application for a clinical study of Captisol-enabled melphalan HCL (CDX-353).
Melphalan is an FDA-approved low dose chemotherapy for multiple myeloma marketed under the brand name – Alkeran by GlaxoSmithKline.
Reportedly, the upcoming clinical studies are expected to begin with a phase 2(a) trial that compares pharmacokinetics of CyDex’s CDX-353: Propylene Glycol-Free Melphalan HCL with Alkeran, and evaluate safety parameters.
Theron Odlaug, president and CEO of CyDex, said: “IND acceptance for Captisol-enabled melphalan is an important milestone for CyDex as we work to develop a portfolio of new drugs for the hospital acute care market. We look forward to establishing a relationship with a strategic out-licensing partner to advance CDX-353 into the clinic and, longer-term, develop and commercialize this promising oncology product.”