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news.CyDex Pharmaceuticals, a specialty pharmaceutical company, has initiated patient dosing in the Phase 2A clinical trial of its Captisol-Enabled Melphalan HCL (CDX-353).
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Melphalan is an FDA-approved chemotherapy for the palliative treatment of multiple myeloma marketed under the brand name Alkeran by GlaxoSmithKline.
CyDex said that the trial will compare the pharmacokinetics of CyDex’s CDX-353: Propylene Glycol-Free Melphalan HCL for Injection with Alkeran for Injection and evaluate safety parameters.
Additionally, CyDex is working in partnership with The University of Kansas Cancer Center on the trial, which will be partially funded by a grant the company received from the Kansas Bioscience Authority, the company added.
Earlier, FDA had accepted CyDex’s investigational new drug (IND) application for a clinical study of CDX-353, in July 2009. In December 2008, CyDex received orphan-drug designation from the FDA for melphalan ‘as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation,’ which would grant the company seven years of exclusive marketing rights upon approval.
Theron Odlaug, president and CEO of CyDex, said: “Our Captisol technology improves the solubility and stabilisation of active pharmaceutical ingredients. We look forward to establishing a relationship with a strategic out-licensing partner to assist in further developing and commercialising Captisol-Enabled Melphalan. In addition, we extend our thanks to The University of Kansas Cancer Center and Kansas Bioscience Authority for supporting this important clinical trial.”