Pharmalink announced that the FDA has granted Orphan Drug designation to Busulipo (MZH-2), a conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT).

RELATED: Hematological Disorders Resource Center

Busulipo has been developed as a liposome/lipid complex formulation that improves the safety and stability of the chemotherapy agent busulfan, and is aimed at becoming the new gold standard for use in conditioning prior to HSCT.

An early Busulipo formulation has successfully undergone clinical trials with more than 90 patients treated. Pharmalink is currently preparing for the pivotal clinical trials with this formulation, which are expected to start in 2014.

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