Alkeran

The positive results of the Phase II study will allow the follow-on pivotal study to use a dosing regimen comparable to Alkeran.

The Phase II trial successfully met all endpoints, and PK analysis revealed that the new PG-free melphalan met the requirements for establishment of bioequivalence to Alkeran

PK analyses revealed that the new propylene glycol-free melphalan met the requirements for bioequivalence to Alkeran.

PK analysis revealed that the new propylene glycol-free Melphalan met the requirements for establishment of bioequivalence to Alkeran

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.

Alkeran is packaged as two separate vials that must be combined prior to injection and, due to its limited stability, administered immediately thereafter.

Effective March 31, 2009, ALKERAN is no longer commercialized by Celgene as we concluded the ALKERAN license agreement with GlaxoSmithKline.

As of March 31, 2009, ALKERAN will no longer be commercialized by Celgene as we conclude the ALKERAN license agreement with GlaxoSmithKline.

Alkeran is packaged as two separate vials that must be combined prior to use and, due to its limited stability, administered shortly thereafter.