Initial Patients Treated in Multinational Phase 2/3 Study of ChemGenex’s Ceflatonin®
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (September 20, 2006).
ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today that it has begun treating patients in its multi-national phase 2/3 study evaluating the use of Ceflatonin® (homoharringtonine, HHT) in patients with chronic, accelerated and blast-phase chronic myeloid leukemia (CML) who have the T315I bcr-abl point mutation. That mutation is associated with resistance to Gleevec® and other tyrosine kinase inhibitor therapeutics recently approved or known to be in development, and it is increasing in prevalence among patients with CML.
As previously announced, the study is being conducted in both the United States and Europe and is projected to enroll up to 81 patients by mid-2007, with individuals possessing the T315I bcr-abl mutation identified in partnership with Molecular MD. The primary endpoint for the trial will be hematologic response rate, and the secondary endpoint will be cytogenetic response rate.
“We are very pleased to begin treating patients in this key trial of Ceflatonin® and anticipate completing enrolment in this trial in mid-2007,” said Greg Collier, Ph.D., Chief Executive Officer and Managing Director of ChemGenex. “If this study is successful, we could file for initial U.S. approval of Ceflatonin® in this drug resistant population around the end of 2007. Additional phase 2 trials of Ceflatonin® are also underway, aimed at showing Ceflatonin’s® utility in combination with Gleevec®, for the treatment of residual disease and to prolong Gleevec® sensitivity.”
Ceflatonin® is a registered trade-mark of ChemGenex Pharmaceuticals Limited.
Gleevec® is a registered trade-mark of Novartis AG.
About Ceflatonin®
Ceflatonin® (homoharringtonine or HHT) is a potent inducer of apoptosis (programmed cell death) in myeloid cells and inhibits angiogenesis (blood vessel formation). In phase 2 studies, Ceflatonin® demonstrated clinical activity in patients with CML, both as a single agent and in combination with other chemotherapeutic drugs. ChemGenex is developing Ceflatonin® for the treatment of CML, myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
Ceflatonin has a different mechanism of action than tyrosine kinase inhibitors (TKIs), which are widely used in the treatment of CML. A registration-directed, international phase 2/3 clinical study is currently in progress, investigating the effectiveness of Ceflatonin® in the treatment of CML patients who have developed resistance to TKI therapy due to the T315I Bcr-Abl point mutation. Ceflatonin® was recently granted Fast Track status by the U.S. Food and Drug Administration (FDA) for this clinical indication. Additional studies will assess the activity of Ceflatonin® in CML patients who are refractory to, or intolerant of treatment with TKIs and investigate if combination therapy with Ceflatonin®, TKIs and other agents increases the cytogenetic and molecular response rates in CML patients.
Ceflatonin® is not approved by the FDA as a treatment in any indication and is being evaluated in clinical trials for efficacy and safety for future regulatory applications.
About ChemGenex Pharmaceuticals Limited
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes, obesity, and depression. ChemGenex harnesses the power of genomics for target discovery and validation, and in clinical trials to develop more individualized therapeutic outcomes. ChemGenex's lead compound, Ceflatonin®, is currently in phase 2/3 clinical trials for chronic myeloid leukemia and Quinamed® is in phase 2 clinical development for prostate, breast and ovarian cancers. The company has a significant portfolio of anti-cancer, diabetes, obesity and depression programs, several of which have been partnered with international pharmaceutical companies. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP".
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