Phase 2 trials will begin for a new form of melphalan (Alkeran), a form of low-dose chemotherapy for multiple myeloma patients, made by CyDex Pharmaceuticals, Inc. These studies will compare the effectiveness of CyDex’s new melphalan, Propylene Glycol-Free Melphalan HCL (CDX-353), and GlaxoSmithKline’s Alkeran in multiple myeloma patients who will be undergoing stem cell transplants.

According to CyDex’s press release, the advantages of the new treatment are its one-vial packaging, gentler formula, and increased stability at room temperature. “These advantages have the potential to enable doctors to safely achieve a higher dose intensity of pre-transplant chemotherapy, which could lead to better therapeutic outcomes,” said Dr. Parameswaran Hari, clinical director of the Adult Bone Marrow Transplant Program and an associate professor at the Medical College of Wisconsin.

CyDex’s first Phase 2 trial will start this August with 24 study subjects, but is not yet open to recruiting participants according to the National Institutes of Health’s ClinicalTrials.gov. CyDex estimated that it will finish its tests in December 2010.

In December 2008, the FDA gave orphan drug designation to CyDex’s Proylene Glycol-Free Melphalan HCL as a preparatory treatment for stem cell transplants. This “orphan status,” as the FDA calls it, gives companies tax credits and marketing incentives to make products for diseases that affect less than 200,000 people in the United States. CyDex will have exclusive marketing rights to its new melphalan for seven years.

For more information, please see the CyDex Pharmaceuticals press release (pdf) and the ClinicalTrials.gov document on CyDex’s upcoming Phase 2 trial.