CXS Chemgenex Fpo

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omapro™ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who are resistant or intolerant to two or more tyrosine kinase inhibitors (TKI). New data were presented at the 51st Annual American Society of Hematology Meeting in New Orleans, Louisiana.

At the Oral Session titled “Chronic Myeloid Leukemia - Therapy: New Trends in Management,” Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center, and a lead investigator in the study, presented data on behalf of ChemGenex and a team of investigators from leading U.S. and European clinical research centers. Completing his presentation, Dr. Cortes concluded that Omapro represents a new potential therapy for patients with multi-TKI resistant CML.

Data were presented from 89 CML patients: 44 in chronic phase, 25 in accelerated phase and 20 in blast phase. Highlights of the data were:

• Complete hematologic responses (CHR) in 82% of chronic phase patients, median response duration 4.8 months
• Cytogenetic response rate of 27% in chronic phase patients, with major cytogenetic response (MCyR) rate of 23%
• Overall hematologic responses in 80% of accelerated phase patients, with 52% achieving a CHR (median duration 3.1 months).
• Overall hematologic responses in 50% of blast phase patients with 35% achieving a CHR (median duration 2.5 months)
• Investigators reported that omacetaxine is safe for self-administration, is well tolerated, and that reversible and manageable myelosuppression is the most common side effect

“Omapro continues to show that it may provide clinical benefit for CML patients who have developed resistance to currently approved therapies independent of the T315I point mutation” said Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex. “We would like to thank Dr. Cortes and all of our investigators for their efforts to complete this trial.”

About the Study

The study was designed to evaluate the safety and efficacy of subcutaneously (SC) administered omacetaxine in patients who are resistant or intolerant to two or more TKIs. Eligible patients were adult CML patients in chronic, accelerated, or blast disease phase (CP, AP, BP). Patients were given 1.25 mg/m2 SC omacetaxine twice daily for 14 days every 28 days until hematologic response for induction therapy. For maintenance therapy, patients were dosed 1.25 mg/m2 SC omacetaxine twice daily for 7 days every 28 days. Eighty nine patients were described in this presentation (44 CP, 25 AP and 20 BP). The median age was 59 years (20-78) with a median CML disease duration of 72, 92 and 60 months in CP, AP and BP patients, respectively.

About Omapro™ (omacetaxine mepesuccinate)

Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global phase 2/3 clinical trials for CML and 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.

Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). In addition, pre-clinical research presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany this summer, demonstrated that omacetaxine kills human CML stem cells that are known to be insensitive to TKIs.

About Chronic Myeloid Leukemia (CML)

Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of approximately 200,000 patients. The bone marrow is responsible for the production of specialized cells that constitute blood; these cells include red blood cells (to carry oxygen around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the body’s defense system against infection). In patients with CML the cell production system is diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.

About ChemGenex Pharmaceuticals Limited

ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorisation Application has been validated by the European Medicines Agency for CML patients with the Bcr-Abl T315I mutation. The corporate strategy for ChemGenex is to commercialize omacetaxine independently in North America and to establish commercial partnerships in the rest of the world. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS." For additional information on ChemGenex Pharmaceuticals, please visit the company’s website at http://www.chemgenex.com.

Details on the clinical trials can be accessed from the following websites:

http://www.clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and

http://www.tkiresistantcmltrials.com

Omapro™ is a trademark of ChemGenex Pharmaceuticals Limited

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