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ChemGenex Announces Initiation of Second Phase 2/3 Clinical Trial for Ceflatoninr in CML
04 / 04 / 2007
ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today that it has treated the first patient in a new phase 2/3 clinical study (CML-203) designed to evaluate the efficacy of Ceflatoninr (homoharringtonine or HHT) in patients with chronic myeloid leukemia (CML) who have failed or were intolerant to treatment with two or more prior tyrosine kinase inhibitors (TKIs). The new study is designed to complement the ongoing registration-directed clinical trial in CML patients with the T315I point mutation and will recruit CML patients from chronic, accelerated and blast-phase disease states.
CML patients routinely receive treatment with imatinib mesylate (Gleevecr) and dasatinib (Sprycelr), TKIs that are approved in both the United States and Europe. In addition, other TKIs are available as experimental therapies. Patients who are resistant or intolerant to the approved TKIs have limited treatment options. The CML-203 study is designed to evaluate whether Ceflatonin can provide clinical benefit to such patients.
The first patient was enrolled into CML-203 at the MD Anderson Cancer Center in Houston, Texas, and ChemGenex is expanding the study to an estimated 15 centers through the United States and Europe. It is anticipated that 50-75 patients will be enrolled into CML-203, and that initial data from the study will become available in the first half of calendar year 2008. The primary endpoint for the study will be hematologic response rate, and the cytogenetic response rate will be one of the secondary endpoints assessed.
"Initiation of the CML-203 study represents the achievement of another important milestone for ChemGenex," said Greg Collier, Ph.D., ChemGenex's Managing Director and Chief Executive Officer. "This is a companion study to our ongoing CML-202 study, which will form the basis of our initial new drug application (NDA). CML-203 should provide the basis for filing a supplementary NDA, thereby expanding the potential market for the drug."
Clinical Trial Details
CML-203 is a multi-national open-label study which has opened initially at the MD Anderson Cancer Center in Houston, Texas. The trial will expand to approximately 14 additional centers in both the United States and Europe.
In the remission induction phase of treatment, patients will receive 1.25 mg/m2 HHT by subcutaneous injection two times a day for 14 consecutive days, with cycles repeated every 28 days. In the remission maintenance phase, patients will receive 1.25 mg/m2 HHT by subcutaneous injection two times a day for 7 consecutive days, with cycles repeated every 28 days. Patients will be stratified according to stage of disease, i.e. chronic phase (CP), accelerated phase (AP), or blast phase (BP) CML. The study will be conducted in two stages, using a Simon two-stage study design for each patient subpopulation. During the first stage, 13 evaluable patients from each patient subpopulation (CP, AP, BP CML) will be enrolled. If one or more responses are seen during the first stage of a subpopulation, another 12 evaluable patients from that subpopulation will be enrolled in the second stage. It is anticipated that a maximum of 75 patients will be enrolled into the study, if all three subpopulations proceed to the second stage. The primary and secondary endpoints are hematologic and cytogenetic response rates, respectively.
CML patients routinely receive treatment with imatinib mesylate (Gleevecr) and dasatinib (Sprycelr), TKIs that are approved in both the United States and Europe. In addition, other TKIs are available as experimental therapies. Patients who are resistant or intolerant to the approved TKIs have limited treatment options. The CML-203 study is designed to evaluate whether Ceflatonin can provide clinical benefit to such patients.
The first patient was enrolled into CML-203 at the MD Anderson Cancer Center in Houston, Texas, and ChemGenex is expanding the study to an estimated 15 centers through the United States and Europe. It is anticipated that 50-75 patients will be enrolled into CML-203, and that initial data from the study will become available in the first half of calendar year 2008. The primary endpoint for the study will be hematologic response rate, and the cytogenetic response rate will be one of the secondary endpoints assessed.
"Initiation of the CML-203 study represents the achievement of another important milestone for ChemGenex," said Greg Collier, Ph.D., ChemGenex's Managing Director and Chief Executive Officer. "This is a companion study to our ongoing CML-202 study, which will form the basis of our initial new drug application (NDA). CML-203 should provide the basis for filing a supplementary NDA, thereby expanding the potential market for the drug."
Clinical Trial Details
CML-203 is a multi-national open-label study which has opened initially at the MD Anderson Cancer Center in Houston, Texas. The trial will expand to approximately 14 additional centers in both the United States and Europe.
In the remission induction phase of treatment, patients will receive 1.25 mg/m2 HHT by subcutaneous injection two times a day for 14 consecutive days, with cycles repeated every 28 days. In the remission maintenance phase, patients will receive 1.25 mg/m2 HHT by subcutaneous injection two times a day for 7 consecutive days, with cycles repeated every 28 days. Patients will be stratified according to stage of disease, i.e. chronic phase (CP), accelerated phase (AP), or blast phase (BP) CML. The study will be conducted in two stages, using a Simon two-stage study design for each patient subpopulation. During the first stage, 13 evaluable patients from each patient subpopulation (CP, AP, BP CML) will be enrolled. If one or more responses are seen during the first stage of a subpopulation, another 12 evaluable patients from that subpopulation will be enrolled in the second stage. It is anticipated that a maximum of 75 patients will be enrolled into the study, if all three subpopulations proceed to the second stage. The primary and secondary endpoints are hematologic and cytogenetic response rates, respectively.