Omapro™ (Omacetaxine mepesuccinate) is a first-in-class small molecule which as a single agent is being evaluated in clinical trials in a range of hematological malignancies. Omapro has a novel mode of action, and induces apoptosis by inhibition of protein synthesis, particularly Mcl-1. As Omapro acts independently of tyrosine kinase inhibitors, it may have therapeutic advantages for patients who have developed resistance to tyrosine kinase inhibitor therapy. Omapro is administered subcutaneously.

We are currently conducting registration-directed clinical trials in CML patients who have failed imatinib therapy and who have the T315I point mutation. These patients, who are increasing in number, do not respond to TKI therapy. Data presented at ASH 2009 reported major cytogenetic responses in 41% of chronic phase patients, and complete hematologic responses in 86% of chronic phase patients. Omapro has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as fast track status by the FDA.

In addition to this registration-directed clinical trial, data was presented at ASH 2009 on a phase 2 trial in CML patients who have failed multiple TKI therapies.

ChemGenex’s development strategy is to seek initial approval for Omapro in T315I+ CML as a single agent. We also plan to develop Omapro as a single agent in multi-TKI resistant CML patients and as a combination therapy with TKIs in some CML patients. Opportunities for development and possible approval in MDS, acute myelogenous leukemia (AML) and solid tumors will also be pursued.

For further information on any of the CML studies you can log on to www.tkiresistantcml.com.

ChemGenex has one issued patent and has filed nine patent applications covering omacetaxine compositions, formulations, synthesis and uses.