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news.ChemGenex Pharmaceuticals, a developer of personalized oncology medicines, has announced that the FDA has granted orphan drug designation to omacetaxine for the treatment of myelodysplastic syndromes.
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Omacetaxine mepesuccinate is a first-in-class cetaxine with established clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, and induces apoptosis by inhibition of protein synthesis, particularly Mcl-1, the company said.
Greg Collier, managing director and CEO of ChemGenex, said: “Orphan designation for omacetaxine reflects our corporate strategy of expanding the use of the drug to other hematological conditions where new treatment options are needed to improve patient outcomes.
“Whilst expansion into myelodysplastic syndromes is integral to realizing the full commercial potential of omacetaxine, we remain focused on our primary objective of seeking regulatory approval for the drug in chronic myeloid leukemia patients with the T315I mutation. The enrollment target for our registration-directed clinical trial for omacetaxine was achieved on schedule in December 2008, and we remain on track to complete the rolling new drug application submission to the FDA in mid 2009.”