Patient dosing in CyDex Pharmaceuticals' Phase 2A clinical trial of CDX-353 initiated

Mar 22 2010

CyDex Pharmaceuticals, Inc. today announced the initiation of patient dosing in the company’s Phase 2A clinical trial of its Captisol-Enabled^® Melphalan HCL (CDX-353). Melphalan is an FDA-approved chemotherapy for the palliative treatment of multiple myeloma marketed under the brand name Alkeran^® by GlaxoSmithKline.

“Our Captisol technology improves the solubility and stabilization of active pharmaceutical ingredients”

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. 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.

“Our Captisol technology improves the solubility and stabilization of active pharmaceutical ingredients,” said Theron E. Odlaug, CyDex’s president and chief executive officer. “We look forward to establishing a relationship with a strategic out-licensing partner to assist in further developing and commercializing 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.”

In July 2009, the U.S. Food and Drug Administration (FDA) accepted CyDex’s Investigational New Drug (IND) application for a clinical study of CDX-353. 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.

“Partnering with local bioscience companies like CyDex is an important part of our strategic vision to develop drugs and get them to patients quickly,” said Roy Jensen, MD, director of The University of Kansas Cancer Center.