ChemGenex on a roll
Tuesday, 01 July, 2008
ChemGenex [ASX: CXS] has submitted the non-clinical section of its New Drug Application [NDA] to the US FDA for omacetaxine, the company's chronic myeloid leukaemia treatment.
The non-clinical section is the first of three in the company's rolling submission: the next steps are the chemistry and manufacturing controls segment and the clinical section.
ChemGenex expects that both remaining submissions will be complete by mid-2009.
The FDA has already granted fast-track designation to the drug, omacetaxine mepesuccinate, for treatment of patients who have failed prior treatment with Novartis' imatinib mesylate, or Glivec.
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