ChemGenex Investigators Present Data on Clinical Activity of Omacetaxine in Imatinib-Resistant Chronic Myeloid Leukemia Patients
April 01 2008 - 7:00AM
Business Wire
ChemGenex Pharmaceuticals (ASX:CXS)(NASDAQ:CXSP) has announced
interim results from its ongoing phase 2/3 trial of omacetaxine
mepesuccinate (formerly known as Ceflatonin�) in chronic myeloid
leukemia (CML) patients with the T315I mutation. The data continue
to show an increase in the number of patients responding with
increasing duration of response in chronic and accelerated phase
patients. Dr. David Marin of the Hammersmith Hospital, Imperial
College London is delivering an oral presentation of the updated
clinical data on behalf of a team of leading international
hematologists at the New Directions in Leukemia Research (NDLR)
conference being held at the Sunshine Coast, Queensland, Australia
later today. The registration-directed clinical trial of
omacetaxine is in imatinib (Gleevec�)-resistant chronic myeloid
leukemia (CML) patients with the T315I mutation. The mutation
causes resistance to imatinib and second-generation tyrosine kinase
inhibitors including dasatinib and nilotinib and is acknowledged as
a major therapeutic challenge in the treatment of CML, and an unmet
medical need. To date 34 patients have been enrolled in the study,
and data will be presented from 25 evaluable patients: 15 in
chronic phase, 4 in accelerated phase and 6 in blast phase.
Highlights of the data include: Hematologic and/or cytogenetic
responses in 86% of chronic phase patients on trial. Complete
hematologic responses (CHR) in 60% of chronic phase patients, and
cytogenetic responses in 20% of chronic phase patients. Hematologic
responses in all accelerated phase patients and in 2 of 6 blast
phase patients. Two chronic phase patients have maintained their
complete hematologic responses for more than 14 months. Median
durations of hematologic response for chronic and accelerated phase
patients of 8.5 months and 9.9 months, respectively. Omacetaxine
therapy is associated with myelosuppression which is manageable and
reversible. �This is a positive expansion on the clinical data
presented by the ChemGenex team at ASH in 2007,� said Dr. Marin.
�We are seeing that omacetaxine has a beneficial effect on the
majority of patients with the T315I mutation. These are patients
who no longer respond to tyrosine kinase inhibitor therapy, and for
whom a novel therapy is needed.� �We are very pleased with the
updated preliminary clinical data on omacetaxine in T315I positive
CML patients,� said Dr. Greg Collier, ChemGenex�s Managing Director
and Chief Executive Officer. �We are seeing an increase in the
number of patients who are responding to omacetaxine and a
prolongation of response duration in chronic and accelerated phase
patients. We look forward to the completion of clinical trial
enrollment within the year, and to regulatory submission after that
time.� Ceflatonin� is a registered trade-mark of ChemGenex
Pharmaceuticals Limited. Gleevec�/Glivec� is a registered
trade-mark of Novartis AG. About ChemGenex Pharmaceuticals Limited
(http://www.chemgenex.com) ChemGenex Pharmaceuticals is a
pharmaceutical development company dedicated to improving the lives
of patients by developing personalized oncology medicines.
ChemGenex harnesses the power of genomics both to discover novel
targets and drug compounds, and in clinical trials to develop more
individualized treatment outcomes. ChemGenex�s lead compound,
omacetaxine mepesuccinate (formerly known as Ceflatonin�), is
currently in phase 2/3 clinical trials for chronic myeloid leukemia
(CML). ChemGenex has a second anticancer compound, amonafide
dihydrochloride (formerly known as Quinamed�) which is in phase 2
clinical development for various solid cancers, and a portfolio of
assets in pre-clinical development. ChemGenex currently trades on
the Australian Stock Exchange under the symbol "CXS" and on NASDAQ
under the symbol "CXSP". Safe Harbor Statement Certain statements
made herein that use the words �estimate�, �project�, �intend�,
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Private Securities Litigation Reform Act of 1995. These
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uncertainties which could cause the actual results, performance or
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among others, risks or uncertainties associated with the
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successfully market products in the clinical pipeline, the ability
to advance promising therapeutics through clinical trials, the
ability to establish our fully integrated technologies, the ability
to enter into additional collaborations and strategic alliances and
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potential limitations on the company�s technology, the market for
the company�s products, government regulation in Australia and the
United States, changes in tax and other laws, changes in
competition and the loss of key personnel. These statements are
based on our management�s current expectations and are subject to a
number of uncertainties that could change the results described in
the forward-looking statements. Investors should be aware that
there are no assurances that results will not differ from those
projected.
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