Singapore, March 11, 2008:  ChemGenex Pharmaceuticals, a pharmaceutical development company dedicated to improving the lives of patients, currently trading on Australian Stock Exchange and NASDAQ has launched a new phase 2 study evaluating the use of omacetaxine mepesuccinate (formerly homoharringtonine, HHT) in refractory or relapsed acute myeloid leukemia (AML) patients who have failed intensive chemotherapy. 

 

Initiation of the AML study represents the next step in ChemGenex’s development strategy for omacetaxine, complementing its two ongoing clinical studies in chronic myeloid leukemia (CML). The study will be conducted in France and is designed as a two-stage study with potential enrolment of up to 27 patients. The primary endpoint will be the proportion of patients achieving complete and partial remissions, and the secondary endpoints will include survival.

 

AML is a cancer of the myeloid line of white blood cells, characterized by the rapid proliferation of abnormal cells that accumulate in the bone marrow and interfere with the production of normal blood cells. AML is the most common acute leukemia affecting adults with an estimated 30,000 new cases per year in the developed world, more than twice that of CML.  The incidence of AML is increasing with increased life expectancy and ageing of the general population.

 

Despite significant advances in cancer therapy over the past twenty years the treatment outcomes for AML patients, particularly those over 60 years old, have not improved and the overall survival rate is poor.  Omacetaxine’s novel mechanism of action is distinct from existing AML therapies and therefore offers a potential new approach to the treatment of the growing number of AML patients with poor clinical prognoses.

 

“There is a clear need for improved therapeutic treatments for AML patients who have relapsed or progressed after first line therapies, and we believe that omacetaxine may offer a new option for these patients. Our understanding of the mechanism of action of omacetaxine, along with previous clinical experience in a range of leukemias, particularly in CML patients, provides a strong basis for developing omacetaxine for the treatment of AML,” said Dr Greg Collier, Chief Executive Officer and Managing Director of ChemGenex.