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ChemGenex Announces Initiation of Second Phase 2/3 Clinical Trial for Ceflatonin® in CML

MELBOURNE, Australia, and MENLO PARK, California, U.S.A. (April 4, 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 Ceflatonin® (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 (Gleevec®) and dasatinib (Sprycel®), 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.
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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.

About Ceflatonin

Ceflatonin (HHT) is a potent inducer of apoptosis (programmed cell death) in myeloid cells and inhibits angiogenesis (blood vessel formation). In phase 2 studies, Ceflatonin has 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, and pilot studies are underway in myelodysplastic syndrome (MDS) and in acute myeloid leukemia (AML).
Ceflatonin has a different mechanism of action than tyrosine kinase inhibitors (TKIs), and ongoing clinical studies seek to determine:
1. Efficacy in treatment of CML patients who have developed resistance to TKI therapy due to development of the T315I bcr-abl kinase domain point mutation. The T315I bcr-abl mutation, which develops in some CML patients treated with TKIs, is associated with resistance to Gleevec and Sprycel;
2. Efficacy in CML patients who have failed therapy with or are intolerant to two TKIs, e.g., Gleevec and Sprycel and;
3. Efficacy as combination therapy with Gleevec, for the treatment of residual disease and to prolong Gleevec sensitivity in CML patients who have developed resistance to Gleevec.
Ceflatonin is not approved by the FDA as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

About Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) is a cancer of the blood cells caused in the majority of cases by an acquired genetic defect called the bcr-abl mutation. This defect occurs when genetic material from two chromosomes (9 and 22) swaps places, creating the so-called Philadelphia chromosome. The bcr-abl mutation interferes with normal cell replication processes, leading to an abnormal proliferation of white blood cells.
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CML usually occurs in adults and typically progresses through three phases. Patients generally are diagnosed in ‘chronic phase’, progress through ‘accelerated phase’ and then may die if the disease progresses to ‘blast phase’. CML incidence is relatively consistent, occurring at about 1 to 2 per 100,000 people, and the global CML market for therapeutics is significant.

Ceflatonin® is a registered trademark of ChemGenex Pharmaceuticals Limited.
Gleevec®/Glivec® is a registered trademark of Novartis AG.
Sprycel® is a registered trademark of the Bristol-Myers Squibb Company.